Treatment of bone loss and changes in bone architecture in osteopenic patients with Crohn's disease; a comparison between calcium supplementation and vitamin D alone or combined with oral Risedronate 35 mg once weekly.
Completed
- Conditions
- Crohn's disease and osteopenia.
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 130
Inclusion Criteria
1. Men and women „d 18 < 70 years of age;
Exclusion Criteria
1. Patients with a DXA T-score < -2.5 in lumbar spine or total hip;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to determine the change in BMD, expressed as T-score, at lumbar spine and total hip as assessed by DXA after 24 months of treatment with Calcium 1g and vitamin D3 400 IU o.d., with concomitant weekly 35mg risedronate (Actonel®) compared to placebo in patients suffering from Crohn’s disease.
- Secondary Outcome Measures
Name Time Method 1. To study the histomorphometric, microarchitectural and mineralization changes in bone after treatment of bone loss in patients with Crohn’s disease with calcium and vitamin D alone or in combination with risedronate;<br /><br>2. To determine changes in markers of bone metabolism (bonespecific alkaline phosphatase, osteocalcine, and type-1 collagen C-telopeptide);<br /><br>3. To establish the incidence of non-vertebral and vertebral fractures, as measured by semi-quantitative assessment of digital, standardized radiographs of the spine.