High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
University of Rochester
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 researchers determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.
Description
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 questi…
Eligibility
- Age range
- 50+ years
- Sex
- Male
- Healthy volunteers
- No
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 rat…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood
- Dietary SupplementD Vitamin
Given PO
- ProcedureDual X-ray Absorptiometry
Undergo DXA scan
- DrugPlacebo Administration
Given PO
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Locations (51)
- Helen F Graham Cancer CenterNewark, Delaware
- Medical Oncology Hematology Consultants PANewark, Delaware
- Carle at The RiverfrontDanville, Illinois
- Cancer Care Specialists of Illinois - DecaturDecatur, Illinois
- Carle Physician Group-EffinghamEffingham, Illinois
- Carle Physician Group-Mattoon/CharlestonMattoon, Illinois