Effects of calcitriol or calcium on bone mineral density, bone turnover, and fractures in men with primary osteoporosis: A two-year randomized, double blind, double placebo study

Peter R. Ebeling, John D. Wark, Stella Yeung, Cathy Poon, Nouria Salehi, Geoffrey C. Nicholson, Mark A. Kotowicz

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Osteoporosis in men is an emerging public health problem. As calcitriol reduces the rate of vertebral fractures in osteoporotic postmenopausal women, we conducted a prospective study of this treatment in men with primary osteoporosis. Our study was a 2-yr, randomized, double masked, double placebo-controlled trial of calcitriol (0.25 μg twice daily) or calcium (500 mg twice daily) in 41 men with primary osteoporosis and at least 1 baseline fragility fracture. Thirty-three men (85%) completed the study. There were no differences in baseline characteristics. Spinal and femoral neck bone mineral densities at 2 yr were unchanged in both groups. Serum osteocalcin decreased in both groups by 30% (P < 0.05), whereas urine N-telopeptide cross-links decreased only in the calcium group by 30% (P < 0.05). After 2 yr, fractional calcium absorption increased by 34% (P < 0.01) in the calcitriol group. Nineteen incident fragility fractures occurred (14 vertebral and 5 nonvertebral) in 7 men. Over 2 yr, the number of men with vertebral fractures (6 vs. 1; P = 0.097) was similar in both groups. In conclusion, the efficacy of calcitriol remains unproven as a single agent for the treatment of osteoporosis in men.

Original languageEnglish
Pages (from-to)4098-4103
Number of pages6
JournalThe Journal of Clinical Endocrinology & Metabolism
Issue number9
Publication statusPublished - 1 Jan 2001
Externally publishedYes

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