Alendroninezuur effectiever dan alfacalcidol voor preventie van osteoporose bij patiënten met een reumatische ziekte die starten met glucocorticoïdtherapie

To compare the effects of alendronate and alfacalcidol in the prevention of glucocorticoid-related osteoporosis in patients with a rheumatic disease.

Design

Randomised, double-blind, double-placebo clinical trial (www.clinicaltrials.gov; number: NCT00138983).

Methods

A total of 201 patients with rheumatic disease who were starting glucocorticoid treatment at a daily dose that was equivalent to at least 7.5 mg of prednisone were randomised to alendronate (10 mg) and a placebo capsule of alfacalcidol daily (n = 100) or alfacalcidol (1 μg) and a placebo tablet of alendronate daily (n = 101) for 18 months. Primary outcome was change in lumbar spine bone mineral density at 18 months. The main secondary outcome was the incidence of morphometrically confirmed vertebral deformities.

Results

Overall, 163 patients completed the study. The bone mineral density of the lumbar spine increased by 2.1 (95 CI: 1.1-3.1) in the alendronate group and decreased by 1.9 (95 CI: –3.1-–0.7) in the alfacalcidol group. At 18 months the mean difference in change in bone mineral density between the two groups was 4.0 (95 CI: 2.4-5.5). Three patients in the alendronate group had a new vertebral deformity, compared with 8 patients in the alfacalcidol group, including 5 symptomatic vertebral fractures in 3 patients; the hazard ratio was 0.4 (95 CI: 0.1-1.4).

Conclusion

Alendronate was more effective than alfacalcidol in preventing glucocorticoid-induced bone loss during this 18-month trial in patients with rheumatic diseases who were starting glucocorticoid treatment.

Ned Tijdschr Geneeskd. 2007;151:1178-85