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.
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 microg 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.
Ebeling
P R
PR
Department of Diabetes, University of Melbourne Hospital, Melbourne, Parkville 3050, Australia.
Wark
J D
JD
Yeung
S
S
Poon
C
C
Salehi
N
N
Nicholson
G C
GC
Kotowicz
M A
MA
D000328:Adult; D000368:Aged; D015519:Bone Density / Q000187:drug effects*; D001842:Bone and Bones / Q000187:drug effects / Q000378:metabolism*; D002117:Calcitriol / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002118:Calcium / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D003720:Densitometry; D004311:Double-Blind Method; D050723:Fractures, Bone / Q000378:metabolism / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015675:Osteocalcin / Q000097:blood; D010024:Osteoporosis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000378:metabolism; D010281:Parathyroid Hormone / Q000097:blood; D011859:Radiography; D013131:Spine / Q000000981:diagnostic imaging
D010281:Parathyroid Hormone; D015675:Osteocalcin; D002117:Calcitriol; D002118:Calcium