Home › Trials › NCT05838716

High-dose vitamin D for bone health in older prostate cancer patients on hormone therapy

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

Phase 3 Interventional University of Rochester · NCT05838716

This study is testing if high-dose vitamin D can help older prostate cancer patients on hormone therapy keep their bones strong and reduce the risk of falls and fractures.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment240 (estimated)
Ages50 Years and up
SexMale
SponsorUniversity of Rochester Academic / other
Drugs / interventionsdenosumab
Locations51 sites (Newark, Delaware and 50 other locations)
Trial IDNCT05838716 on ClinicalTrials.gov

What this trial studies

This phase III trial investigates the effectiveness of high-dose vitamin D supplementation in preventing bone loss in older prostate cancer patients undergoing androgen-deprivation therapy (ADT). The study aims to measure changes in bone mineral density at various sites, including the hip and spine, over a 52-week period using dual-energy x-ray absorptiometry (DXA). Additionally, it evaluates the impact of supplementation on falls, fractures, quality of life, and other health outcomes. Participants will be randomized to receive either high-dose vitamin D or a placebo, with assessments conducted throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates are men aged 60 and older with Stage I-IV prostate cancer who are starting or have recently begun ADT.

Not a fit: Patients with a history of long-term use of bone-modifying agents or those with severe vitamin D deficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help maintain bone density and reduce the risk of fractures in older men receiving ADT for prostate cancer.

How similar studies have performed: Previous studies have shown promising results with vitamin D supplementation in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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 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 Criteria:

* 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

Where this trial is running

Newark, Delaware and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Stage I Prostate Cancer AJCC v8Stage II Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.