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

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 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.

Osteoporosis Treatment Efficacy for Men: A Systematic Review and Meta‐Analysis

“…The literature searches identified 6,475 records (citations) for review; 2,673 of these were excluded because they were duplicates (same citation found in different databases), leaving 3,802 unique records for review. Twenty‐four of these records reporting results for 22 different studies met inclusion criteria . Figure shows a flow diagram of the literature search and study selection.…”

“…Only two included studies performed head‐to‐head comparisons of drugs that the FDA has approved for men—one study that compared teriparatide with alendronate and another study that compared zoledronic acid with alendronate; neither of these studies reported RR of fracture outcomes. Most studies reported pharmaceutical company funding …”

The relationship between daily calcium intake and bone mineral density in men with prostate cancer

“…In a 2‐year, randomized, double‐blind study of 33 patients with at least one osteoporotic fracture, Ebeling et al. [17] concluded that calcium supplementation (500 mg/day) did not prevent subsequent osteoporotic fractures to a significant extent. Dawson‐Hughes et al.…”

MANAGEMENT OF ENDOCRINE DISEASE: Therapeutics of vitamin D

“…Evidence of anti-fracture effectiveness, in fact, is weaker for other vitamin D analogues as compared with vitamin D 3 , while the risk of side effects is higher (13). Calcitriol (1,25(OH)2 vitamin D) for example, had no statistically significant effect on hip fracture, non-vertebral fractures or new vertebral deformities (13,18). Two trials suggested that vertebral fractures may be prevented by 1α-hydroxycalciferol (alfacalcidol).…”