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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Helen F Graham Cancer Center
  Newark, Delaware, United States Recruiting
• Medical Oncology Hematology Consultants PA
  Newark, Delaware, United States Recruiting
• Carle at The Riverfront
  Danville, Illinois, United States Recruiting
• Cancer Care Specialists of Illinois - Decatur
  Decatur, Illinois, United States Recruiting
• Carle Physician Group-Effingham
  Effingham, Illinois, United States Recruiting
• Carle Physician Group-Mattoon/Charleston
  Mattoon, Illinois, United States Recruiting

+1 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Luke J Peppone — University of Rochester NCORP Research Base

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.