Background & aims: Low bone mineral density (BMD) is a common complication of Crohn's disease and may lead to increased morbidity and mortality because of fractures. We investigated the effect of treatment with the bisphosphonate alendronate on bone mass and markers of bone remodeling in patients with Crohn's disease.
Methods: A 12-month double-blind, randomized, placebo-controlled trial examined the effect of a 10-mg daily dose of alendronate. Thirty-two patients with a bone mass T score of -1 of the hip or lumbar spine were studied. The main outcome measure was the difference in the mean percent change in BMD of the lumbar spine measured by dual-energy x-ray absorptiometry. Secondary outcome measures included changes in BMD of the hip and total body and biochemical markers of bone turnover (S-osteocalcin, urine pyridinoline, and urine deoxypyridinoline excretion).
Results: Mean (+/-SEM) BMD of the lumbar spine showed an increase of 4.6% +/- 1.2% in the alendronate group compared with a decrease of 0.9% +/- 1.0% in patients receiving placebo (P < 0.01). BMD of the hip increased by 3.3% +/- 1.5% in the alendronate group compared with a smaller increase of 0.7% +/- 1.1% in the placebo group (P = 0.08). Biochemical markers of bone turnover decreased significantly in the alendronate group (P < 0.001). Alendronate was well tolerated, and there was no difference in adverse events among treatment groups.
Conclusions: Treatment with alendronate, 10 mg daily, significantly increased BMD in patients with Crohn's disease and was safe and well tolerated.