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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

Departments of Diabetes and Endocrinology (P.R.E., J.D.W., S.Y., C.P.) and Nuclear Medicine (N.S.), and Medicine, University of Melbourne Hospital, and Department of Medicine, Royal Melbourne Hospital (P.R.E., J.D.W.), Melbourne, Parkville 3050, Australia; and Department of Medicine, Geelong Hospital (G.C.N., M.A.K.), Geelong, Victoria 3220, Australia

Address all correspondence and requests for reprints to: Dr. Peter R. Ebeling, Department of Diabetes and Endocrinology, The Royal Melbourne Hospital, Melbourne, Victoria 3050, Australia.

Abstract

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.

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