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

Launched by UNIVERSITY OF ROCHESTER NCORP RESEARCH BASE · Apr 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether taking high doses of vitamin D can help prevent bone loss in older men with prostate cancer who are receiving androgen-deprivation therapy (ADT). ADT is a common treatment for prostate cancer that can lead to weaker bones, making it easier for patients to fall or feel more tired. The researchers hope that by giving participants high doses of vitamin D, they can help strengthen their bones and improve their overall well-being during treatment.

To join the trial, participants must be men aged 60 and older, diagnosed with stage I to IV prostate cancer that hasn’t spread to the bones. They should be starting ADT treatment or have begun it within the last three months. It’s important that they have a certain level of vitamin D in their blood and a normal kidney function. Participants in the trial will receive vitamin D supplements provided by the study and will need to avoid other calcium or vitamin D supplements during the trial. This study is currently recruiting and aims to see if vitamin D can make a positive difference for men undergoing ADT.

Gender

MALE

Eligibility 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 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 27 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