Alendronate or alfacalcidol in glucocorticoid-induced osteoporosis.
BACKGROUND
Treatment with glucocorticoids is associated with bone loss starting soon after therapy is initiated and an increased risk of fracture.


METHODS
We performed a randomized, double-placebo, double-blind clinical trial of 18 months' duration among patients with a rheumatic disease who were starting glucocorticoids at a daily dose that was equivalent to at least 7.5 mg of prednisone. A total of 201 patients were assigned to receive either alendronate (10 mg) and a placebo capsule of alfacalcidol daily or alfacalcidol (1 microg) and a placebo tablet of alendronate daily. The primary outcome was the change in bone mineral density of the lumbar spine in 18 months; the secondary outcome was the incidence of morphometric vertebral deformities.


RESULTS
A total of 100 patients received alendronate, and 101 received alfacalcidol; 163 patients completed the study. The bone mineral density of the lumbar spine increased by 2.1 percent in the alendronate group (95 percent confidence interval, 1.1 to 3.1 percent) and decreased by 1.9 percent in the alfacalcidol group (95 percent confidence interval, -3.1 to -0.7 percent). At 18 months, the mean difference of change in bone mineral density between the two groups was 4.0 percent (95 percent confidence interval, 2.4 to 5.5 percent). Three patients in the alendronate group had a new vertebral deformity, as compared with eight patients in the alfacalcidol group (of whom three had symptomatic vertebral fractures) (hazard ratio, 0.4; 95 percent confidence interval, 0.1 to 1.4).


CONCLUSIONS
During this 18-month trial in patients with rheumatic diseases, alendronate was more effective in the prevention of glucocorticoid-induced bone loss than was alfacalcidol. (ClinicalTrials.gov number, NCT00138983 [ClinicalTrials.gov].).
de Nijs
Ron N J
RN
Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands. r.denijs@mmc.nl
Jacobs
Johannes W G
JW
Lems
Willem F
WF
Laan
Roland F J
RF
Algra
Ale
A
Huisman
Anne-Margriet
AM
Buskens
Erik
E
de Laet
Chris E D
CE
Oostveen
Ans C M
AC
Geusens
Piet P M M
PP
Bruyn
George A W
GA
Dijkmans
Ben A C
BA
Bijlsma
Johannes W J
JW
D000368:Aged; D019386:Alendronate / Q000627:therapeutic use*; D015519:Bone Density; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D006887:Hydroxycholecalciferols / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced* / Q000188:drug therapy*; D012216:Rheumatic Diseases / Q000188:drug therapy*; D013131:Spine
D050071:Bone Density Conservation Agents; D005938:Glucocorticoids; D006887:Hydroxycholecalciferols; C008088:alfacalcidol; D019386:Alendronate