Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT01215890|
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : October 7, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease Low Bone Mineral Density||Drug: risedronate Drug: placebo||Phase 4|
|Study Type :||Interventional (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|
|Active Comparator: risedronate plus calcium and viamin D||Drug: risedronate|
|Placebo Comparator: placebo plus clacium and vitamin D||Drug: placebo|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215890
|Gastrointestinal and Liver Disease Research (GILDR) Group|
|Edmonton, Alberta, Canada, T6G-2X8|
|Principal Investigator:||Richard Fedorak, MD||University of Alberta|