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

Not Applicable

Completed

• Conditions: Crohn's, Osteopenia; Digestive System; Noninfective enteritis

• Registration Number: ISRCTN59682218
• Lead Sponsor: Aventis (The Netherlands)

Brief Summary

2013 Results article in https://gut.bmj.com/content/63/9/1424 (added 20/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-20
• Study Completion: 2007-08-31
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

1. Men and women between 18 and 70 years of age
2. Patients suffering from Crohn's disease of at least three months duration, confirmed by radiography, endoscopy and histology
3. Quiescent stage of disease as defined by the Crohn's Disease Activity Index (CDAI less than 150)
4. A Bone Mineral Density (BMD) between -1.0 SD and -2.5 SD as assessed by Dual Energy X-ray Absorptiometry (DEXA) (T-score) of lumbar spine or total hip
5. A serum 25(OH)-vitamin D level more than 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

1. Patients with a DEXA T-score less than -25 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 one year
4. Patients with serum 25(OH)-vitamin D levels less than 25 nmol/L (supplementation for three months prior to (renewed) screening is allowed)
5. Corticosteroid treatment three months prior to screening or during the screening phase with daily dosages above 75 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

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 DEXA after 24 months of treatment with Calcium 1 g and vitamin D3 400 IU once daily (o.d.), with concomitant weekly 35 mg risedronate (Actonel®) compared to placebo in patients suffering from Crohn?s disease.

Secondary Outcome Measures

Name	Time	Method
<br> 1. To study the histomorphometric, micro architectural and mineralisation 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> 2. To determine changes in markers of bone metabolism (bone specific alkaline phosphatase, osteocalcine, and type-one collagen C-telopeptide)<br> 3. To establish the incidence of non-vertebral and vertebral fractures, as measured by semi-quantitative assessment of digital, standardised radiographs of the spine<br>