Efficacy and safety of doxercalciferol (1α hydroxyvitamin D2) on spine and femur bone mineral density in postmenopausal osteopenic women
Abstract
Background: The use of small doses of vitamin D3 analogs or metabolites is common in the prevention of renal osteodystrophy. Their use in the treatment of osteoporosis has been limited by their potent adverse effects, causing hypercalcemia and hypercalciuria. We evaluated a vitamin D2 analog, i.e., 1α-hydroxyvitamin D2 (doxercalciferol), that has a lower incidence of adverse effects.
Methods: In a 1-year pilot randomized double-blind, placebo-controlled study, 55 postmenopausal women (aged 60-71 years) with osteopenia were treated for a year with either doxercalciferol or placebo, and 41 women completed an optional second year. The dose of 1 µg was increased by 1 µg at weekly intervals to a maximum of 5 µg. The daily dose of doxercalciferol averaged 4.1 µg after 12 months and 3.6 µg after 24 months. Bone mineral density (BMD) measurements by dual-energy X-ray absorptiometry (DEXA) of the spine and femoral neck were obtained at 6-month intervals for 24 months. The serum and urine calcium levels were measured frequently for safety.
Results: In the primary intention-to-treat (ITT) analysis at 12 months, there was no significant difference between the two groups for femoral neck and spine BMD. At 24 months, there was a significant difference in favor of doxercalciferol for femoral neck BMD, with the treatment/placebo difference being 1.70% (p p = 0.36). In the per-protocol analysis at 12 months, the doxercalciferol/placebo difference for femoral neck was 0.5% (p = 0.497) and for…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 55 participants or records.
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