History of Changes for Study: NCT05838716

High-Dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	April 20, 2023	None (earliest Version on record)
2	September 5, 2023	Study Status
3	November 20, 2023	Study Status and Oversight
4	January 16, 2024	Recruitment Status, Study Status and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	URCC-22053
Brief Title:	High-Dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
Official Title:	High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
Secondary IDs:	NCI-2022-07664 [Registry Identifier: CTRP (Clinical Trial Reporting Program)] URCC-22053 [University of Rochester NCORP Research Base] URCC-22053 [DCP] URCC-22053 [CTEP] R01CA258349 [U.S. NIH Grant/Contract] UG1CA189961 [U.S. NIH Grant/Contract]

Study Status


Record Verification:	April 2023
Overall Status:	Not yet recruiting
Study Start:	August 5, 2023
Primary Completion:	May 31, 2026 [Anticipated]
Study Completion:	May 31, 2027 [Anticipated]

First Submitted:	April 20, 2023
First Submitted that Met QC Criteria:	April 20, 2023
First Posted:	May 1, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	April 20, 2023
Last Update Posted:	May 1, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	University of Rochester NCORP Research Base
Responsible Party:	Principal Investigator Investigator: Luke Peppone Official Title: Principal Investigator Affiliation: University of Rochester NCORP Research Base
Collaborators:	National Cancer Institute (NCI)

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

Brief Summary:

This phase III trial tests whether high-dose vitamin D works in treating androgen-deprivation therapy (ADT)-induced bone loss in patients with prostate cancer who are undergoing androgen-deprivation therapy. Vitamins are substances that the body needs to grow and develop normally. Vitamin D helps the body absorb calcium. Calcium is one of the main building blocks of bone. A lack of vitamin D can lead to bone diseases such as osteoporosis or rickets. This trial may help researcher determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the effect of high-dose vitamin D (HDVD) supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the total hip over 52 weeks as measured by dual-energy x-ray absorptiometry (DXA).

II. To evaluate the effect of HDVD supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the femoral neck, distal radius, and lumbar spine (L1-L4) over 52 weeks as measured by DXA.

SECONDARY OBJECTIVES:

I. To evaluate the effect of HDVD supplementation on falls over 52 weeks as measured by the Falls History questionnaire.

II. To evaluate the effect of HDVD supplementation on fractures over 52 weeks as determined by the Clinical Record Information - Follow-up Form.

III. To evaluate the effect of HDVD supplementation on quality of life over 52 weeks as measured by the Functional Assessment of Cancer Therapy- Prostate (FACT-P).

EXPLORATORY OBJECTIVES:

I. To explore the effect of HDVD supplementation on skeletal muscle mass as measured by DXA.

II. To explore the effect of HDVD supplementation on bone biomarkers measured by Millipore Luminex/enzyme-linked immunosorbent assay (ELISA) assays from serum.

III. To evaluate the effect of HDVD supplementation on pain, fatigue, sleep, and activities of daily living over 52 weeks as measured by patient-reported outcomes.

OUTLINE: After undergoing collection of blood and DXA scan, patents are randomized to 1 of 2 arms.

ARM I: Patients receive HDVD orally (PO) throughout the study. Patients also undergo collection of blood and DXA scan on study.

ARM II: Patients receive placebo PO throughout the study. Patients also undergo collection of blood and DXA scan on study.

Conditions


Conditions:	Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Supportive Care
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Single (Investigator)
Allocation:	Randomized
Enrollment:	366 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Experimental: Arm I (HDVD)

Patients receive HDVD PO throughout the study. Patients also undergo collection of blood and DXA scan on study.

Procedure: Biospecimen Collection

Undergo collection of blood

Other Names:

Biological Sample Collection
Biospecimen Collected
Specimen Collection

Dietary Supplement: D Vitamin

Given PO

Other Names:

3-[2-[7a-methyl-1-(1,4,5-trimethylhex-2-enyl)-1,2,3,3a,5,6,7,7a-octahydroinden-4-ylidene]ethylidene]-4-methylidene-cyclohexan-1-ol
Vitamin D
Vitamin D Compound
Vitamin-D

Procedure: Dual X-ray Absorptiometry

Undergo DXA scan

Other Names:

BMD scan
bone mineral density scan
DEXA
DEXA (Bone Density)
DEXA Scan
dual energy x-ray absorptiometric scan
Dual Energy X-ray Absorptiometry
Dual X-Ray Absorptometry
DXA
DXA SCAN

Quality-of-Life Assessment

Ancillary studies

Other Names:

Quality of Life Assessment

Questionnaire Administration

Ancillary studies

Placebo Comparator: Arm II (placebo, DXA scan, blood collection, questionnaire)

Patients receive placebo PO throughout the study. Patients also undergo collection of blood and DXA scan on study.

Procedure: Biospecimen Collection

Undergo collection of blood

Other Names:

Biological Sample Collection
Biospecimen Collected
Specimen Collection

Procedure: Dual X-ray Absorptiometry

Undergo DXA scan

Other Names:

BMD scan
bone mineral density scan
DEXA
DEXA (Bone Density)
DEXA Scan
dual energy x-ray absorptiometric scan
Dual Energy X-ray Absorptiometry
Dual X-Ray Absorptometry
DXA
DXA SCAN

Drug: Placebo Administration

Given PO

Quality-of-Life Assessment

Ancillary studies

Other Names:

Quality of Life Assessment

Questionnaire Administration

Ancillary studies

Outcome Measures


Primary Outcome Measures:
1.	Reduction of bone mineral density (BMD) loss as measured at the total hip [ Time Frame: At 52 weeks ] Will determine the efficacy of high-dose vitamin D (HDVD) supplementation versus placebo in reducing BMD loss as measured at the total via dual-energy x-ray absorptiometry (DXA) at 52 weeks. Will use analysis of variance (ANCOVA) with Group (vitamin D or placebo) as the main factor, baseline BMD as covariate, and T3 (week 52) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial linear mixed model (LMM) will be fit using Restricted Maximum Likelihood (REML) estimation. The significance of the variance due to study site will be tested using the Wald Test.
2.	Reduction of BMD loss as measured at the lumbar spine [ Time Frame: At 52 weeks ] Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the lumbar spine total via DXA at 52 weeks. Will use ANCOVA with Group (vitamin D or placebo) as the main factor, baseline BMD as covariate, and T3 (week 52) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial LMM will be fit using REML estimation. The significance of the variance due to study site will be tested using the Wald Test.

Eligibility


Minimum Age:	60 Years
Maximum Age:
Sex:	Male
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Be diagnosed with Stage I-IV prostate cancer without metastases to bone (lymph node involvement and prior diagnosis of a primary cancer is allowed) Be age 60 years or older Be starting ADT or have received their first ADT treatment in the past 3 months, with at least 6 planned months of treatment remaining (both luteinizing hormone-releasing hormone (LHRH) antagonists and LHRH agonists are permitted) Have a total serum vitamin D between 10 and 27 ng/ml Have an total serum calcium of less than or equal to 10.5 mg/dl Have a normal GFR (glomerular filtration rate) Agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided by the study Be able to provide written informed consent Be able to swallow pills and capsules Be able to speak and read English Exclusion Criteria: Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or IV bisphosphonates, denosumab, or teriparatide prior to enrollment Have a diagnosis of stage IV chronic kidney disease Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 10.5 mg/dl) Have a history of hypercalcemia or vitamin D toxicity/sensitivity

Contacts/Locations


Study Officials:	Luke J Peppone Principal Investigator University of Rochester NCORP Research Base
Locations:

IPDSharing


Plan to Share IPD:

References


Citations:
Links:
Available IPD/Information: