Trial record 1 of 1 for:
TVB-009
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
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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 |
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Recruitment Status :
Completed
First Posted : January 28, 2021
Results First Posted : April 18, 2024
Last Update Posted : April 18, 2024
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Sponsor:
Teva Pharmaceuticals USA
Collaborator:
Teva Branded Pharmaceutical Products R&D, Inc.
Information provided by (Responsible Party):
Teva Pharmaceuticals USA
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Brief Summary:
The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoporosis, Postmenopausal | Combination Product: TVB-009 Combination Product: Prolia® | Phase 3 |
This is a multinational, multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of TVB-009 compared to Prolia® administered subcutaneously at doses of 60 mg every 26 weeks. Approximately 326 postmenopausal women with osteoporosis will be randomized to receive either TVB-009 or Prolia®. At week 52, patients in the Prolia® arm will be re-randomized 1:1 to either continue with a third dose of Prolia® or transition to TVB-009 and receive a single dose of TVB-009 in the transition period to assess immunogenicity and safety after a transition from Prolia® to TVB-009. The total treatment duration for each patient is 78 weeks.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 332 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Multinational, Multicenter Study to Compare Efficacy, Safety, and Immunogenicity of TVB-009P and Denosumab (Prolia®) in Patients With Postmenopausal Osteoporosis |
| Actual Study Start Date : | March 22, 2021 |
| Actual Primary Completion Date : | December 31, 2022 |
| Actual Study Completion Date : | June 19, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Osteoporosis
Drug Information
available for:
Denosumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: TVB-009 main treatment period
TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26
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Combination Product: TVB-009
TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
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Active Comparator: PROLIA main treatment period
Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26
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Combination Product: Prolia®
Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
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Experimental: TVB-009 main / TVB-009 transition period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period
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Combination Product: TVB-009
TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
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Active Comparator: PROLIA main / PROLIA transition period
Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
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Combination Product: Prolia®
Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
|
Experimental: PROLIA main / TVB-009 transition period
TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period
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Combination Product: TVB-009
TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) Combination Product: Prolia® Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
Primary Outcome Measures :
- Percent Change From Baseline in LS-BMD at Week 52 [ Time Frame: Baseline and week 52 ]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
Secondary Outcome Measures :
- Percent Change From Baseline in sCTX-1 at Week 26 [ Time Frame: Baseline and week 26 ]Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen at week 26
- Percent Change From Baseline in LS-BMD at Week 26 [ Time Frame: Baseline and week 26 ]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
- Percent Change From Baseline in Femoral Neck BMD at Week 26 [ Time Frame: Baseline, week 26 ]Percent change from baseline in femoral neck bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA)at week 26
- Percent Change From Baseline in Total Hip BMD at Week 26 [ Time Frame: Baseline, week 26 ]Percent change from baseline in total hip bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 26
- Percent Change From Baseline in sCTX-1 [ Time Frame: Baseline through Week 52 ]Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen
- Percentage of Participatns With sCTX-1 Suppression at Week 4 [ Time Frame: Week 4 ]Proportion of patients with suppression of serum C-telopeptide cross-link of type 1 collagen at week 4
- Percent Change From Baseline in P1NP [ Time Frame: Baseline through Week 52 ]Percent change from baseline in procollagen type 1 N propeptide (P1NP) to Week 52
- Number of Fractures up to Week 52 [ Time Frame: Up to week 52 ]Number of patients with who experienced any new fractures up to week 52.
- Percent Change From Week 52 in LS-BMD by DXA at Week 78 [ Time Frame: Week 52 through week 78 ]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
- Percent Change From Week 52 in Femoral Neck BMD by DXA at Week 78 [ Time Frame: Week 52 through week 78 ]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
- Percent Change From Week 52 in Total Hip BMD by DXA at Week 78 [ Time Frame: Week 52 through week 78 ]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
- Difference Between Percent Change From Baseline in sCTX-1 Between Week 52 and Week 78 [ Time Frame: Baseline, Week 52, Week 78 ]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
- Difference Between Percent Change From Baseline in P1NP Between Week 52 and Week 78 [ Time Frame: Baseline, Week 52, Week 78 ]The difference in the Percent change from baseline in procollagen type 1 N propeptide at Week 78 compared to Week 52.
- Number of Patients With Fractures Between Week 52 and Week 78 [ Time Frame: Week 52 through week 78 ]Number of patients experiencing new fractures between week 52 and week 78
- Incidence of Adverse Event [ Time Frame: Up to week 52 ]Number of patients reporting at least one treatment-emergent adverse event up to week 52
- Incidence of Adverse Events in the Transition Period [ Time Frame: Week 52 through week 78 ]Number of patients reporting at least one treatment-emergent adverse event between weeks 52 and 78
- Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period [ Time Frame: Anytime Post Baseline through Week 52 ]Number of patients with confirmed positive antidrug antibodies (ADAs) post-baseline through Week 52
- Incidence of Antidrug Antibodies (ADAs) in the Transition Period [ Time Frame: Anytime in Week 52 through Week 78 ]Number of patients with confirmed positive antidrug antibodies (ADAs) at Week 65
- Percent Change From Baseline in Femoral Neck BMD at Week 52 [ Time Frame: Baseline through Week 52 ]Percent change from baseline in femoral neck bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA)at week 52
- Percent Change From Baseline in Total Hip BMD at Week 52 [ Time Frame: Baseline through Week 52 ]Percent change from baseline in total hip bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52
- Number of TEAEs Leading to Patient Withdraw From the Study [ Time Frame: Main Treatment Period = Baseline-Week 52; Transition period = Week 52-78 ]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.
- Local Tolerability at Injection Site [ Time Frame: Main Treatment Period = Day 1 & Week 26; Transition Treatment Period = Week 52 ]Number of patients who report Injection Site Reactions at Day 1, Week 26, or Week 52.
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| Ages Eligible for Study: | 60 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Postmenopausal womeen (≥60 and ≤90 years) with a diagnosis of osteoporosis
- Body weight ≥50 kg and ≤90 kg
- Bone Mineral Density (BMD) measurement T score of less than -2.5 but not less than -4.0 by dual-energy X-ray absorptiometry (DXA) at the lumbar spine at screening
- At least 3 vertebrae in the L1 L4 region that are evaluable by dual-energy X-ray absorptiometry (DXA)
Exclusion Criteria:
- One severe or more than two moderate vertebral fractures
- History and/or presence of hip fracture or atypical femur fracture
- Any prior treatment with denosumab
- Ongoing use of any bone active drugs which can affect Bone Mineral Density (BMD)
- Vitamin D deficiency or hyper- or hypocalcemiacium at screening
- Hyperthyroidism, hypothyroidism, hypoparathyroidism or hyperparathyroidism
- Any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study
Other Inclusion/exclusion criteria may apply
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04729621
Locations
Show 78 study locations
Sponsors and Collaborators
Teva Pharmaceuticals USA
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
| Study Director: | Teva Medical Expert, MD | Teva Pharmaceuticals, Inc. |
Study Documents (Full-Text)
Documents provided by Teva Pharmaceuticals USA:
Documents provided by Teva Pharmaceuticals USA:
Study Protocol [PDF] June 29, 2021
Statistical Analysis Plan [PDF] April 18, 2023
| Responsible Party: | Teva Pharmaceuticals USA |
| ClinicalTrials.gov Identifier: | NCT04729621 |
| Other Study ID Numbers: |
TVB009-IMB-30085 |
| First Posted: | January 28, 2021 Key Record Dates |
| Results First Posted: | April 18, 2024 |
| Last Update Posted: | April 18, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Metabolic Diseases Denosumab Bone Density Conservation Agents Physiological Effects of Drugs |