Crohn's Disease Clinical Trial
Official title:
A Randomized, Data Collection Program To Determine the Efficacy and Safety of Risedronate (Actonel) Therapy Plus Calcium and Vitamin D Supplementation Versus Placebo Plus Calcium and Vitamin D Supplementation in the Treatment of Low Bone Mineral Density in Crohn's Disease Patients
The occurrence of bone loss in Crohn's disease patients is an important clinical problem for
both patients with and without active disease. While therapy does exist for treatment and
prevention of low BMD, evidence of its efficacy in Crohn's disease patients is lacking. The
current standard of therapy in Canada for the treatment of osteoporosis is etidronate, with
adequate calcium and vitamin D supplementation.
The primary objective of the study is to assess the efficacy of risedronate, compared to
placebo, administered once-weekly, in the treatment of low BMD of the spine and hip in
patients with Crohn's disease at 12 months, based on an intention-to-treat analysis.
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