StudyFinder
High-Dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
RECRUITING
60 years and over
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/sensitivityPROCEDURE: Biospecimen Collection, DIETARY_SUPPLEMENT: D Vitamin, PROCEDURE: Dual X-ray Absorptiometry, DRUG: Placebo Administration, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
Brooke Burgess, MS - URCC_22053@urmc.rochester.edu
PHASE3
NCT05838716