PRIMARY OBJECTIVES:~I. To evaluate the effect of high-dose vitamin D (HDVD) supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the total hip over 52 weeks as measured by dual-energy x-ray absorptiometry (DXA).~II. To evaluate the effect of HDVD supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the femoral neck, distal radius, and lumbar spine (L1-L4) over 52 weeks as measured by DXA.~SECONDARY OBJECTIVES:~I. To evaluate the effect of HDVD supplementation on falls over 52 weeks as measured by the Falls History questionnaire.~II. To evaluate the effect of HDVD supplementation on fractures over 52 weeks as determined by the Clinical Record Information - Follow-up Form.~III. To evaluate the effect of HDVD supplementation on quality of life over 52 weeks as measured by the Functional Assessment of Cancer Therapy- Prostate (FACT-P).~EXPLORATORY OBJECTIVES:~I. To explore the effect of HDVD supplementation on skeletal muscle mass as measured by DXA.~II. To explore the effect of HDVD supplementation on bone biomarkers measured by Millipore Luminex/enzyme-linked immunosorbent assay (ELISA) assays from serum.~III. To evaluate the effect of HDVD supplementation on pain, fatigue, sleep, and activities of daily living over 52 weeks as measured by patient-reported outcomes.~OUTLINE: After undergoing collection of blood and DXA scan, patents are randomized to 1 of 2 arms.~ARM I: Patients receive HDVD orally (PO) throughout the study. Patients also undergo collection of blood and DXA scan on study.~ARM II: Patients receive placebo PO throughout the study. Patients also undergo collection of blood and DXA scan on study.
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.