Abstract
Androgen deprivation therapy (ADT) inhibits prostate cancer growth. However, ADT causes loss of bone mineral density (BMD) and an increase in fracture risk; effective interventions for ADT-induced bone loss are limited. A phase 2 randomized controlled trial investigated the feasibility, safety, and preliminary efficacy of high-dose weekly vitamin D (HDVD, 50,000 IU/week) versus placebo for 24 weeks in patients with prostate cancer receiving ADT, with all subjects receiving 600 IU/day vitamin D and 1000 mg/day calcium. Participants were ≥60 years (mean years, 67.7), had a serum 25-hydroxyvitamin D level <32 ng/mL, and initiated ADT within the previous 6 months. At baseline and after intervention, dual-energy x-ray absorptiometry was used to assess BMD, and levels of bone cell, bone formation, and resorption were measured. The HDVD group (N=29) lost 1.5% BMD at the total hip vs. 4.1% for the low-dose group (N=30; p=.03) and 1.7% BMD at the femoral neck vs. 4.4% in the low-dose group (p=.06). Stratified analyses showed that, for those with baseline 25-hydroxyvitamin D level <27 ng/mL, the HDVD group lost 2.3% BMD at the total hip vs 7.1% for the low-dose group (p<.01). Those in the HDVD arm showed significant changes in parathyroid hormone (p<.01), osteoprotegerin (p<0.01), N-terminal telopeptide of type 1 collagen (p<0.01) and C-terminal telopeptide of type 1 collagen (p<0.01). No difference in adverse events or toxicity was noted between the groups. HDVD supplementation significantly reduced hip and femoral neck BMD loss, especially for patients with low baseline serum 25-hydroxyvitamin D levels, although demonstrating safety and feasibility in prostate cancer patients on ADT.
Accepted Version
Published Version
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