Crohn's disease and osteopenia.
Conditions
Interventions
For both study groups: 1000mg Calcium and 400 IU vitamin D.
Group I:
weekly 35mg risedronate (Actonel®)
Group II:
weekly 1 placebo tablet.
Patients will receive treatment for 24 months.
Sponsors
Aventis
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women „d 18 25 nmol/L; 6. Patients must be able to adhere to the study visit schedule and protocol requirements; 7. Patients must be able to give informed consent and the consent must be obtained prior to any study procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with a DXA T-score < -2.5 in lumbar spine or total hip; 2. Patients who have received bisphosphonates a year prior to inclusion, or who are known with an allergy to bisphosphonates; 3. Patients who have received calcitonin or suppressive doses of thyroxine within 1 year; 4. Patients with serum 25(OH)-vitamin D levels < 25 nmol/L (supplementation for 3 months prior to (renewed) screening is allowed); 5. Corticosteroid treatment 3 months prior to screening or during the screening phase with daily dosages above 7.5 mg prednisole-equivalent at any time; 6. A history of hyperthyroidism, Paget¡¦s disease or other metabolic bone diseases, Cushing¡¦s disease or hyperprolactinemia; 7. Female patients who are pregnant or breast-feeding; 8. Patients receiving hormonal replacement therapy; 9. A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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; 2. To determine changes in markers of bone metabolism (bonespecific alkaline phosphatase, osteocalcine, and type-1 collagen C-telopeptide); 3. To establish the incidence of non-vertebral and vertebral fractures, as measured by semi-quantitative assessment of digital, standardized radiographs of the spine. | — |
Contacts
Public ContactMaartje Ley, de
Academic Medical Center, IBD trialbureau, C2-317, P.O. Box 22660
Outcome results
None listed