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
| ISRCTN | ISRCTN59682218 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59682218 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 20/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Maartje de Ley
Scientific
Scientific
IBD trial bureau
C2-317
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 6545 |
|---|---|
| m.deley@compaqnet.nl |
Study information
| Study design | Randomised, placebo controlled, parallel group, double blinded multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | 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 |
| Study acronym | Crohn and Bone study |
| Study objectives | Bifosfornates in combination with vitamin D and Calcium is more effective that Vitamin D and Calcium alone for Crohns disease related osteopenia. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Crohn's, Osteopenia |
| Intervention | For both study groups: 1000 mg Calcium and 400 IU vitamin D. Group I: weekly 35 mg risedronate (Actonel®) Group II: weekly one placebo tablet Patients will receive treatment for 24 months. |
| Intervention type | Supplement |
| Primary outcome measure | 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 Crohns disease. |
| Secondary outcome measures | 1. To study the histomorphometric, micro architectural and mineralisation changes in bone after treatment of bone loss in patients with Crohns disease with calcium and vitamin D alone or in combination with risedronate 2. To determine changes in markers of bone metabolism (bone specific alkaline phosphatase, osteocalcine, and type-one collagen C-telopeptide) 3. To establish the incidence of non-vertebral and vertebral fractures, as measured by semi-quantitative assessment of digital, standardised radiographs of the spine |
| Overall study start date | 30/08/2004 |
| Completion date | 31/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 130 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/08/2004 |
| Date of final enrolment | 31/08/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
IBD trial bureau
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Aventis (The Netherlands)
Industry
Industry
P.O. Box 2043
Gouda
2800 BD
Netherlands
| Phone | +31 (0)182 557 696 |
|---|---|
| info.nl@aventis.com | |
"ROR" |
https://ror.org/00pgqb537 |
Funders
Funder type
Industry
Aventis (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 21/10/2013 | 20/08/2021 | Yes | No |
Editorial Notes
20/08/2021: Publication reference added.
