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Vitamin D for Prostate Cancer Bone Loss

This study is looking at whether high-dose vitamin D can help men with prostate cancer who are receiving androgen-deprivation therapy (ADT) to prevent bone loss. ADT is a treatment that can weaken bones. Vitamin D helps your body absorb calcium, which is important for strong bones. Researchers want to see if taking high-dose vitamin D will reduce bone loss in your hips, wrists, and other areas over 52 weeks. They will also look at whether it helps reduce falls, fractures, and fatigue. This study is for men aged 50 or older with Stage I-IVA prostate cancer without bone metastases, who are starting or have recently started ADT.

Study design
This is an interventional study planning to enroll 240 men. Participants will be randomly assigned to receive either high-dose vitamin D or a placebo (an inactive substance) for 52 weeks.
What's involved
You would have blood collected and undergo a DXA scan (a type of bone density scan) at the beginning and during the study. You would take either vitamin D or a placebo by mouth once a week for 52 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for this study are measured at 52 weeks, which suggests follow-up will last at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05838716

Vitamin D for Prostate Endocrine Therapy

Recruiting
PHASE3Ages 50+InterventionalSupportive care
University of Rochester
~240 participants
Updated 2026-01-15 on ClinicalTrials.gov
What's tested:Biospecimen CollectionD VitaminDual X-ray AbsorptiometryPlacebo AdministrationQuality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites
51 of 51 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduction of bone mineral density (BMD) loss as measured at the total hip
Measured over At 52 weeks
+3 more outcomes measured

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

Explore related trials

Prostate CarcinomaCalcium

Where it's being run

51 sites across 14 states
Virginia8
Illinois6
Minnesota6
South Carolina6
Kansas4
Wisconsin4
Louisiana3
Missouri3

Study leadership

  • Luke J Peppone · PRINCIPAL_INVESTIGATOR · University of Rochester NCORP Research Base

Who to contact

Site Public Contact
[email protected]
302-623-4450
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 50 years or older
Be starting ADT or have received their first ADT treatment in the past 6 months, with a total of at least 6 planned months of treatment (both luteinizing hormone-releasing hormone \[LHRH\] antagonists and LHRH agonists are permitted)
Have a total serum vitamin D between 10 and 32 ng/ml
Have a total serum calcium of less than or equal to 10.5 mg/dl
Have a normal GFR (glomerular filtration rate \> 30ml)
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

Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or intravenous (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 11.5 mg/dl)
Have a history of hypercalcemia or vitamin D toxicity/sensitivity

What this trial measures

  • Reduction of bone mineral density (BMD) loss as measured at the total hipAt 52 weeks

    Will determine the efficacy of high-dose vitamin D (HDVD) supplementation versus placebo in reducing BMD loss as measured at the total hip via dual-energy x-ray absorptiometry (DXA) at 52 weeks. Will use analysis of covariance (ANCOVA) with group (vitamin D or placebo) as the main factor, baseline timepoint (\[T\]1) BMD as covariate, and week 52 (T3) 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.

  • Reduction of BMD loss as measured at the femoral neckAt 52 weeks

    Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the femoral neck via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) 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.

  • Reduction of BMD loss as measured at the distal radiusAt 52 weeks

    Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the distal radius via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) 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.

  • Reduction of BMD loss as measured at the lumbar spineAt 52 weeks

    Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the lumbar spine via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) 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.