The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    TVB-009
Previous Study | Return to List | Next Study

A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04729621
Recruitment Status : Completed
First Posted : January 28, 2021
Results First Posted : April 18, 2024
Last Update Posted : April 18, 2024
Sponsor:
Collaborator:
Teva Branded Pharmaceutical Products R&D, Inc.
Information provided by (Responsible Party):
Teva Pharmaceuticals USA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoporosis, Postmenopausal
Interventions Combination Product: TVB-009
Combination Product: Prolia®
Enrollment 332
Recruitment Details  
Pre-assignment Details 332 subjects were randomized into the study. Those that completed the Main treatment period were then randomized into the transition period. Therefore, the 3 arms noted as "Transition period" are the same subjects that were included in the "Treatment Period".
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Hide Arm/Group Description

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Period Title: Main Treatment Period (Week1 to Week 52)
Started 166 166 0 0 0
Completed 148 143 0 0 0
Not Completed 18 23 0 0 0
Reason Not Completed
Adverse Event             3             7             0             0             0
Withdrawal by Subject             13             12             0             0             0
Multiple Other Reasons             2             4             0             0             0
Period Title: Transition Period (Week 52 to Week 78)
Started [1] 0 0 148 72 71
Completed 0 0 140 67 69
Not Completed 0 0 8 5 2
Reason Not Completed
Withdrawal by Subject             0             0             7             2             1
Lost to Follow-up             0             0             0             1             0
Multiple Other Reasons             0             0             1             2             1
[1]
Subjects who completed the Main Treatment Period were re-randomized to one of 3 new arms.
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period Total
Hide Arm/Group Description

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

 Total of all reporting groups
Overall Number of Baseline Participants 166 166 332
Hide Baseline Analysis Population Description
The baseline characteristics are only presented for the Treatment Period Arms as the same subject were employed in the Transition Period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 166 participants 166 participants 332 participants
68.5  (5.69) 67.7  (5.56) 68.1  (5.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 166 participants 332 participants
Female
166
 100.0%
166
 100.0%
332
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 166 participants 332 participants
Hispanic or Latino
23
  13.9%
18
  10.8%
41
  12.3%
Not Hispanic or Latino
143
  86.1%
148
  89.2%
291
  87.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 166 participants 332 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   0.6%
1
   0.6%
2
   0.6%
White
165
  99.4%
164
  98.8%
329
  99.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   0.6%
1
   0.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Hungary Number Analyzed 166 participants 166 participants 332 participants
11 6 17
United States Number Analyzed 166 participants 166 participants 332 participants
34 35 69
Czechia Number Analyzed 166 participants 166 participants 332 participants
21 19 40
Ukraine Number Analyzed 166 participants 166 participants 332 participants
13 12 25
Poland Number Analyzed 166 participants 166 participants 332 participants
30 37 67
Georgia Number Analyzed 166 participants 166 participants 332 participants
17 9 26
Slovakia Number Analyzed 166 participants 166 participants 332 participants
6 13 19
Bulgaria Number Analyzed 166 participants 166 participants 332 participants
22 20 42
Germany Number Analyzed 166 participants 166 participants 332 participants
1 1 2
Russia Number Analyzed 166 participants 166 participants 332 participants
11 14 25
Previous Use of Biophosphonates  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 166 participants 332 participants
Yes
21
  12.7%
21
  12.7%
42
  12.7%
No
145
  87.3%
145
  87.3%
290
  87.3%
Prior Fractures  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 166 participants 332 participants
Yes
37
  22.3%
38
  22.9%
75
  22.6%
No
129
  77.7%
128
  77.1%
257
  77.4%
Taking Calcium & Vitamin D Supplements   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Yes
28
  75.7%
28
  73.7%
56
  74.7%
No
9
  24.3%
10
  26.3%
19
  25.3%
[1]
Measure Analysis Population Description: Calcium & Vitamin D Supplement status was only required for patients that experienced any fractures prior to study start.
1.Primary Outcome
Title Percent Change From Baseline in LS-BMD at Week 52
Hide Description Percent change from baseline in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52
Time Frame Baseline and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population was used for this analysis. The modified intent-to-treat (mITT) analysis set will include all randomized patients who received at least 1 dose of IMP and had at least 1 post-baseline evaluation of LS-BMD
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 157 152
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage of change from baseline
4.76
(3.82 to 5.69)
4.54
(3.62 to 5.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TVB-009 Main Treatment Period, PROLIA Main Treatment Period
Comments LS means, differences and confidence intervals (CI) from the ANCOVA model with percent change from baseline to Week 52 in LS-BMD as the outcome, treatment group, region and previous use of bisphosphates as fixed effects, baseline LS-BMD and baseline weight as covariates. Missing outcomes imputed using multiple imputation methods under the MAR assumption.
Type of Statistical Test Equivalence
Comments Biosimilarity will be demonstrated if the 95% CI for the difference falls entirely within the equivalence margin of (-1.45, +1.45).
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
-0.73 to 1.15
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline in sCTX-1 at Week 26
Hide Description Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen at week 26
Time Frame Baseline and week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT was used for this analysis. The modified intent-to-treat (mITT) analysis set includes all randomized patients who received at least 1 dose of IMP and had at least 1 post-baseline evaluation of LS-BMD
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 157 152
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage of change from baseline
-56.05
(-64.99 to -47.12)
-65.13
(-74.09 to -56.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TVB-009 Main Treatment Period, PROLIA Main Treatment Period
Comments LS means, differences and confidence intervals (CI) from the ANCOVA model with percent change from baseline to Week 26 in sCTX-1 as the outcome, treatment group, region and previous use of bisphosphates as fixed effects, baseline sCTX-1 and baseline weight as covariates. Missing outcomes are not imputed. Results below the limit of quantification (BLQ) are imputed as the low limit of quantification (LLOQ = 0.033 ng/mL).
Type of Statistical Test Equivalence
Comments Biosimilarity will be demonstrated if the 95% CI for the difference falls entirely within the equivalence margin of (-20, +20).
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 9.07
Confidence Interval (2-Sided) 95%
-0.14 to 18.29
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline in LS-BMD at Week 26
Hide Description Percent change from baseline in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 26
Time Frame Baseline and week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT population was used in this analysis.
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 157 151
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
3.70  (4.294) 3.62  (3.815)
4.Secondary Outcome
Title Percent Change From Baseline in Femoral Neck BMD at Week 26
Hide Description Percent change from baseline in femoral neck bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA)at week 26
Time Frame Baseline, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population was used for this analysis.
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 156 150
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
1.87  (4.877) 2.01  (3.611)
5.Secondary Outcome
Title Percent Change From Baseline in Total Hip BMD at Week 26
Hide Description Percent change from baseline in total hip bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 26
Time Frame Baseline, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population was used for the analysis.
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 156 150
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
1.89  (3.488) 2.02  (2.526)
6.Secondary Outcome
Title Percent Change From Baseline in sCTX-1
Hide Description Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen
Time Frame Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population was used for this analysis.
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 151 146
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
-57.91  (44.161) -68.80  (35.846)
7.Secondary Outcome
Title Percentage of Participatns With sCTX-1 Suppression at Week 4
Hide Description Proportion of patients with suppression of serum C-telopeptide cross-link of type 1 collagen at week 4
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population was used.
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 155 151
Measure Type: Number
Unit of Measure: Percentage of participants
94.2 94.0
8.Secondary Outcome
Title Percent Change From Baseline in P1NP
Hide Description Percent change from baseline in procollagen type 1 N propeptide (P1NP) to Week 52
Time Frame Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population was used for this analysis.
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 151 146
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
-56.43  (35.431) -62.03  (33.712)
9.Secondary Outcome
Title Number of Fractures up to Week 52
Hide Description Number of patients with who experienced any new fractures up to week 52.
Time Frame Up to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population was used.
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 157 152
Measure Type: Number
Unit of Measure: number participants with fractures
3 5
10.Secondary Outcome
Title Percent Change From Week 52 in LS-BMD by DXA at Week 78
Hide Description Percent change from week 52 in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78
Time Frame Week 52 through week 78
Hide Outcome Measure Data
Hide Analysis Population Description
TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD.
Arm/Group Title TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 137 62 68
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
0.82  (3.120) 1.15  (3.440) 1.24  (3.069)
11.Secondary Outcome
Title Percent Change From Week 52 in Femoral Neck BMD by DXA at Week 78
Hide Description Percent change from week 52 in femoral neck bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78
Time Frame Week 52 through week 78
Hide Outcome Measure Data
Hide Analysis Population Description
TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD.
Arm/Group Title TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 137 62 68
Mean (Standard Deviation)
Unit of Measure: Percent change from week 52
0.38  (3.525) 0.80  (3.560) 0.94  (3.082)
12.Secondary Outcome
Title Percent Change From Week 52 in Total Hip BMD by DXA at Week 78
Hide Description Percent change from week 52 in total hip bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78
Time Frame Week 52 through week 78
Hide Outcome Measure Data
Hide Analysis Population Description
TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD.
Arm/Group Title TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 137 62 68
Mean (Standard Deviation)
Unit of Measure: Percent change from week 52
0.01  (2.089) 0.66  (2.109) 0.27  (2.264)
13.Secondary Outcome
Title Difference Between Percent Change From Baseline in sCTX-1 Between Week 52 and Week 78
Hide Description Difference in the percent change from baseline in serum C-telopeptide cross-link of type 1 collagen from baseline to Week 78 as compared to baseline to Week 52
Time Frame Baseline, Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD.
Arm/Group Title TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 137 63 69
Mean (Standard Deviation)
Unit of Measure: Percent change from baseline
9.95  (41.612) 13.17  (28.558) 7.55  (36.509)
14.Secondary Outcome
Title Difference Between Percent Change From Baseline in P1NP Between Week 52 and Week 78
Hide Description The difference in the Percent change from baseline in procollagen type 1 N propeptide at Week 78 compared to Week 52.
Time Frame Baseline, Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD.
Arm/Group Title TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 137 63 69
Mean (Standard Deviation)
Unit of Measure: Percent change
3.95  (23.376) 4.83  (14.551) 2.89  (39.804)
15.Secondary Outcome
Title Number of Patients With Fractures Between Week 52 and Week 78
Hide Description Number of patients experiencing new fractures between week 52 and week 78
Time Frame Week 52 through week 78
Hide Outcome Measure Data
Hide Analysis Population Description
TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD.
Arm/Group Title TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 138 64 69
Measure Type: Number
Unit of Measure: Number participants with fractures
1 0 1
16.Secondary Outcome
Title Incidence of Adverse Event
Hide Description Number of patients reporting at least one treatment-emergent adverse event up to week 52
Time Frame Up to week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAS) was used. The safety analysis set will include all randomized patients who received at least 1 dose of IMP.
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 166 165
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE Related to Study Drug
19
  11.4%
13
   7.9%
TEAE Related to Medical Device
0
   0.0%
0
   0.0%
TEAE Not Related to Study Drug
104
  62.7%
95
  57.6%
No TEAEs Reported
43
  25.9%
57
  34.5%
17.Secondary Outcome
Title Incidence of Adverse Events in the Transition Period
Hide Description Number of patients reporting at least one treatment-emergent adverse event between weeks 52 and 78
Time Frame Week 52 through week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Transition Safety Analysis Set was used. The transition safety analysis set will include all patients who received the third dose of the IMP.
Arm/Group Title TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 148 72 71
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE Related to Study Drug
2
   1.4%
0
   0.0%
0
   0.0%
TEAE Related to Medical Device
0
   0.0%
0
   0.0%
0
   0.0%
TEAE Not Related to Study Drug
48
  32.4%
20
  27.8%
26
  36.6%
No TEAE Reported
98
  66.2%
52
  72.2%
45
  63.4%
18.Secondary Outcome
Title Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period
Hide Description Number of patients with confirmed positive antidrug antibodies (ADAs) post-baseline through Week 52
Time Frame Anytime Post Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set was used. The safety analysis set will include all randomized patients who received at least 1 dose of IMP.
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 166 165
Measure Type: Count of Participants
Unit of Measure: Participants
ADA Status Number Analyzed 166 participants 165 participants
Positive
11
   6.6%
25
  15.2%
Positive, Not Treatment Related
8
   4.8%
11
   6.7%
Negative
147
  88.6%
129
  78.2%
Neutralizing ADA Status Among Positive Number Analyzed 11 participants 25 participants
Positive
1
   9.1%
2
   8.0%
Positive, Not Treatment Related
0
   0.0%
0
   0.0%
Negative
10
  90.9%
23
  92.0%
19.Secondary Outcome
Title Incidence of Antidrug Antibodies (ADAs) in the Transition Period
Hide Description Number of patients with confirmed positive antidrug antibodies (ADAs) at Week 65
Time Frame Anytime in Week 52 through Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
The Transition Safety Analysis Set was used. The transition safety analysis set will include all patients who received the third dose of the IMP.
Arm/Group Title TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 147 70 70
Measure Type: Count of Participants
Unit of Measure: Participants
ADA Status Number Analyzed 147 participants 70 participants 70 participants
Positive
7
   4.8%
5
   7.1%
4
   5.7%
Positive, Not Treatment Related
7
   4.8%
4
   5.7%
1
   1.4%
Negative
133
  90.5%
61
  87.1%
65
  92.9%
Neutralizing ADA Status Among Positive Number Analyzed 7 participants 5 participants 4 participants
Positive
1
  14.3%
0
   0.0%
0
   0.0%
Positive, Not Treatment Related
0
   0.0%
0
   0.0%
0
   0.0%
Negative
6
  85.7%
5
 100.0%
4
 100.0%
20.Secondary Outcome
Title Percent Change From Baseline in Femoral Neck BMD at Week 52
Hide Description Percent change from baseline in femoral neck bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA)at week 52
Time Frame Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population was used for this analysis.
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 150 145
Mean (Standard Deviation)
Unit of Measure: Percent change from baseline
2.39  (5.795) 2.34  (3.780)
21.Secondary Outcome
Title Percent Change From Baseline in Total Hip BMD at Week 52
Hide Description Percent change from baseline in total hip bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52
Time Frame Baseline through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population was used for the analysis.
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 150 145
Mean (Standard Deviation)
Unit of Measure: Percent change from baseline
2.67  (3.981) 3.00  (2.768)
22.Secondary Outcome
Title Number of TEAEs Leading to Patient Withdraw From the Study
Hide Description Number of patients that withdraw or are removed from the study due to treatment emergent adverse events from both the main and transition treatment periods.
Time Frame Main Treatment Period = Baseline-Week 52; Transition period = Week 52-78
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 166 165 148 72 71
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.8%
7
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
23.Secondary Outcome
Title Local Tolerability at Injection Site
Hide Description Number of patients who report Injection Site Reactions at Day 1, Week 26, or Week 52.
Time Frame Main Treatment Period = Day 1 & Week 26; Transition Treatment Period = Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Hide Arm/Group Description:

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Overall Number of Participants Analyzed 166 165 148 72 71
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 166 participants 165 participants 0 participants 0 participants 0 participants
Erythema
5
   3.0%
4
   2.4%
Ecchymosis
4
   2.4%
2
   1.2%
Induration
2
   1.2%
3
   1.8%
Tenderness
3
   1.8%
4
   2.4%
Warmth
0
   0.0%
1
   0.6%
Swelling
2
   1.2%
1
   0.6%
Pain
6
   3.6%
5
   3.0%
No Reaction
144
  86.7%
145
  87.9%
Week 26 Number Analyzed 158 participants 153 participants 0 participants 0 participants 0 participants
Erythema
2
   1.3%
4
   2.6%
Ecchymosis
3
   1.9%
0
   0.0%
Induration
2
   1.3%
0
   0.0%
Tenderness
1
   0.6%
1
   0.7%
Warmth
0
   0.0%
1
   0.7%
Swelling
1
   0.6%
1
   0.7%
Pain
7
   4.4%
4
   2.6%
No Reaction
142
  89.9%
142
  92.8%
Week 52 Number Analyzed 0 participants 0 participants 148 participants 72 participants 71 participants
Erythema
2
   1.4%
2
   2.8%
2
   2.8%
Ecchymosis
3
   2.0%
0
   0.0%
1
   1.4%
Induration
3
   2.0%
3
   4.2%
0
   0.0%
Tenderness
1
   0.7%
1
   1.4%
1
   1.4%
Warmth
0
   0.0%
2
   2.8%
0
   0.0%
Swelling
0
   0.0%
1
   1.4%
1
   1.4%
Pain
6
   4.1%
4
   5.6%
3
   4.2%
No Reaction
133
  89.9%
59
  81.9%
63
  88.7%
Time Frame The Main Treatment Period collected adverse event data for a 52 week period (baseline to week 52). The transitional period collected adverse event data for a 26 week period (week 52 to week 78).
Adverse Event Reporting Description All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Each patient will be counted only once in each preferred term (PT) or system organ class (SOC) category for the analyses of safety.
 
Arm/Group Title TVB-009 Main Treatment Period PROLIA Main Treatment Period TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Hide Arm/Group Description

TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period

TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)

Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
All-Cause Mortality
TVB-009 Main Treatment Period PROLIA Main Treatment Period TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/166 (0.00%)      0/165 (0.00%)      0/148 (0.00%)      0/72 (0.00%)      0/71 (0.00%)    
Hide Serious Adverse Events
TVB-009 Main Treatment Period PROLIA Main Treatment Period TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/166 (4.82%)      6/165 (3.64%)      5/148 (3.38%)      0/72 (0.00%)      1/71 (1.41%)    
Cardiac disorders           
Atrial flutter * 1  0/166 (0.00%)  0 1/165 (0.61%)  1 0/148 (0.00%)  0 0/72 (0.00%)  0 0/71 (0.00%)  0
Myocardial ischaemia * 1  0/166 (0.00%)  0 1/165 (0.61%)  1 0/148 (0.00%)  0 0/72 (0.00%)  0 0/71 (0.00%)  0
Endocrine disorders           
Adrenal mass * 1  1/166 (0.60%)  1 0/165 (0.00%)  0 0/148 (0.00%)  0 0/72 (0.00%)  0 0/71 (0.00%)  0
General disorders           
Malaise * 1  0/166 (0.00%)  0 0/165 (0.00%)  0 1/148 (0.68%)  1 0/72 (0.00%)  0 0/71 (0.00%)  0
Hepatobiliary disorders           
Bile duct stone * 1  1/166 (0.60%)  1 0/165 (0.00%)  0 0/148 (0.00%)  0 0/72 (0.00%)  0 0/71 (0.00%)  0
Cholecystitis acute * 1  0/166 (0.00%)  0 1/165 (0.61%)  1 0/148 (0.00%)  0 0/72 (0.00%)  0 0/71 (0.00%)  0
Cholelithiasis * 1  1/166 (0.60%)  1 0/165 (0.00%)  0 0/148 (0.00%)  0 0/72 (0.00%)  0 1/71 (1.41%)  1
Infections and infestations           
COVID-19 pneumonia * 1  0/166 (0.00%)  0 1/165 (0.61%)  1 1/148 (0.68%)  1 0/72 (0.00%)  0 0/71 (0.00%)  0
Hepatitis C * 1  1/166 (0.60%)  1 0/165 (0.00%)  0 0/148 (0.00%)  0 0/72 (0.00%)  0 0/71 (0.00%)  0
Infective periostitis * 1  1/166 (0.60%)  1 0/165 (0.00%)  0 0/148 (0.00%)  0 0/72 (0.00%)  0 0/71 (0.00%)  0
Helicobacter infection * 1  0/166 (0.00%)  0 0/165 (0.00%)  0 1/148 (0.68%)  1 0/72 (0.00%)  0 0/71 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Osteonecrosis * 1  0/166 (0.00%)  0 1/165 (0.61%)  1 0/148 (0.00%)  0 0/72 (0.00%)  0 0/71 (0.00%)  0
Osteonecrosis of jaw * 1  0/166 (0.00%)  0 1/165 (0.61%)  1 0/148 (0.00%)  0 0/72 (0.00%)  0 0/71 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Gastric neoplasm * 1  1/166 (0.60%)  1 0/165 (0.00%)  0 0/148 (0.00%)  0 0/72 (0.00%)  0 0/71 (0.00%)  0
Splenic marginal zone lymphoma * 1  0/166 (0.00%)  0 1/165 (0.61%)  1 0/148 (0.00%)  0 0/72 (0.00%)  0 0/71 (0.00%)  0
Bone cancer * 1  0/166 (0.00%)  0 0/165 (0.00%)  0 1/148 (0.68%)  1 0/72 (0.00%)  0 0/71 (0.00%)  0
Renal and urinary disorders           
Ureterolithiasis * 1  1/166 (0.60%)  1 0/165 (0.00%)  0 0/148 (0.00%)  0 0/72 (0.00%)  0 0/71 (0.00%)  0
Urinary incontinence * 1  0/166 (0.00%)  0 0/165 (0.00%)  0 1/148 (0.68%)  1 0/72 (0.00%)  0 0/71 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease * 1  0/166 (0.00%)  0 0/165 (0.00%)  0 1/148 (0.68%)  1 0/72 (0.00%)  0 0/71 (0.00%)  0
Vascular disorders           
Peripheral arterial occlusive disease * 1  1/166 (0.60%)  1 0/165 (0.00%)  0 0/148 (0.00%)  0 0/72 (0.00%)  0 0/71 (0.00%)  0
1
Term from vocabulary, MedDRA Version 23.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
TVB-009 Main Treatment Period PROLIA Main Treatment Period TVB-009 Main / TVB-009 Transition Period PROLIA Main / PROLIA Transition Period PROLIA Main / TVB-009 Transition Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   123/166 (74.10%)      108/165 (65.45%)      42/148 (28.38%)      20/72 (27.78%)      11/71 (15.49%)    
Gastrointestinal disorders           
Abdominal pain upper * 1  1/166 (0.60%)  1 5/165 (3.03%)  5 2/148 (1.35%)  2 0/72 (0.00%)  0 1/71 (1.41%)  1
Infections and infestations           
COVID-19 * 1  17/166 (10.24%)  17 22/165 (13.33%)  22 3/148 (2.03%)  3 0/72 (0.00%)  0 1/71 (1.41%)  1
Nasopharyngitis * 1  7/166 (4.22%)  7 9/165 (5.45%)  9 4/148 (2.70%)  4 5/72 (6.94%)  5 0/71 (0.00%)  0
Upper respiratory tract infection * 1  5/166 (3.01%)  5 0/165 (0.00%)  0 3/148 (2.03%)  3 2/72 (2.78%)  2 1/71 (1.41%)  1
Urinary tract infection * 1  6/166 (3.61%)  6 3/165 (1.82%)  3 1/148 (0.68%)  1 1/72 (1.39%)  1 0/71 (0.00%)  0
Investigations           
Vitamin D decreased * 1  10/166 (6.02%)  10 5/165 (3.03%)  5 0/148 (0.00%)  0 0/72 (0.00%)  0 1/71 (1.41%)  1
Metabolism and nutrition disorders           
Hypercalcaemia * 1  14/166 (8.43%)  14 19/165 (11.52%)  19 4/148 (2.70%)  4 2/72 (2.78%)  2 2/71 (2.82%)  2
Vitamin D deficiency * 1  34/166 (20.48%)  34 21/165 (12.73%)  21 2/148 (1.35%)  2 0/72 (0.00%)  0 0/71 (0.00%)  0
Dyslipidaemia * 1  1/166 (0.60%)  1 2/165 (1.21%)  2 0/148 (0.00%)  0 0/72 (0.00%)  0 2/71 (2.82%)  2
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  14/166 (8.43%)  14 13/165 (7.88%)  13 4/148 (2.70%)  4 4/72 (5.56%)  4 0/71 (0.00%)  0
Back pain * 1  9/166 (5.42%)  9 6/165 (3.64%)  6 8/148 (5.41%)  8 2/72 (2.78%)  2 0/71 (0.00%)  0
Pain in extremity * 1  6/166 (3.61%)  6 10/165 (6.06%)  10 3/148 (2.03%)  3 3/72 (4.17%)  3 0/71 (0.00%)  0
Spinal pain * 1  3/166 (1.81%)  3 2/165 (1.21%)  2 3/148 (2.03%)  3 2/72 (2.78%)  2 0/71 (0.00%)  0
Nervous system disorders           
Headache * 1  16/166 (9.64%)  16 15/165 (9.09%)  15 4/148 (2.70%)  4 1/72 (1.39%)  1 3/71 (4.23%)  3
Vascular disorders           
Hypertension * 1  8/166 (4.82%)  8 8/165 (4.85%)  8 1/148 (0.68%)  1 0/72 (0.00%)  0 0/71 (0.00%)  0
1
Term from vocabulary, MedDRA Version 23.1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PI must receive sponsor approval for all publications of study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: US Medical Affairs
Organization: Teva Pharmaceuticals
Phone: 1-888-483-8279
EMail: usmedinfo@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT04729621    
Other Study ID Numbers: TVB009-IMB-30085
First Submitted: January 25, 2021
First Posted: January 28, 2021
Results First Submitted: January 4, 2024
Results First Posted: April 18, 2024
Last Update Posted: April 18, 2024