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

• Status: Not yet recruiting
• Trial end date: 2027-05-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester NCORP Research Base
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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