Longterm Osteopenia in Crohn's Disease Study: Comparing the affect of Calcium & Vitamin D or additional Sodium-Fluoride or Ibandronate on Bone Mineral Density and Fractures in Crohns Disease
| ISRCTN | ISRCTN80829286 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80829286 |
| Secondary identifying numbers | Osteopenie_01 |
- Submission date
- 09/03/2010
- Registration date
- 14/04/2010
- Last edited
- 14/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jochen Klaus
Scientific
Scientific
Albert Einstein Allee 23
Ulm
89081
Germany
Study information
| Study design | 3 arm randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A 3.5 year Randomised Controlled Study on Bone Mineral Density and Fractures in Crohns Disease comparing Calcium & Vitamin D or additional Sodium-Fluoride or Ibandronate |
| Study objectives | To assess the effect of colecalciferol and calcium administration alone or with additional sodium-fluoride or ibandronate on bone mineral density (BMD) and fracture rate in Crohn's disease patients with reduced bone mineral density |
| Ethics approval(s) | The Ethics Committee of the University of Ulm, Germany approved on the 7th of April 1998 (ref: 281998) |
| Health condition(s) or problem(s) studied | Crohn's disease, Osteoporosis |
| Intervention | Patients were randomised to treatment-group A, B and C, taking study-medication as follows: Group A: 10000 International Units (IU) colecalciferol (Vigantoletten®, Merck, Darmstadt/Germany) and 800mg calcium-citrate (Calcitrat®, Merckle, Ulm/Germany) daily Group B: 1000IU colecalciferol and 800mg calcium-citrate daily with an additional 25mg of slow-release sodium-fluoride (Nafril®, Merckle, Ulm/Germany) twice daily (bid) Group C: Basic colecalciferol and calcium with an additional 1mg/IV of ibandronate (Bondronat®, Roche, Basle/Switzerland) 3 times a month Follow-up examinations were conducted at 3-month intervals. In group B, sodium-fluoride was taken daily for 12-months, followed by a 3-months fluoride-free period. The 2nd and 3rd 12-month cycle started at month 15 and 30. |
| Intervention type | Other |
| Primary outcome measure | Dual Energy X-ray Absorptiometry (DEXA) of the lumbar spine and plain radiography of the spine performed at baseline and after 1.0, 2.25 and 3.5 years. |
| Secondary outcome measures | Fracture rate (spine, T4-L4) |
| Overall study start date | 01/04/1998 |
| Completion date | 30/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Crohn's disease 2. Reduced bone mineral density (T-score < -1,0) |
| Key exclusion criteria | 1. Age <18 years 2. Chronic renal insufficiency (creatinine >1,5mg/dl) 3. Known primary hypo- or hyperparathyroidism 4. Untreated thyroid disease 5. Any known medication, e.g. previous treatment with either sodium-fluoride or bisphosphonates 6. Condition affecting BMD other than glucocorticoids |
| Date of first enrolment | 01/04/1998 |
| Date of final enrolment | 30/08/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Albert Einstein Allee 23
Ulm
89081
Germany
89081
Germany
Sponsor information
University Hospital Ulm (Universitätsklinikum Ulm) (Germany)
University/education
University/education
Clinic for Internal Medicine I
(Klinik für Innere Medizin I)
Albert-Einstein-Allee 23
Ulm
89081
Germany
| Website | http://www.uniklinik-ulm.de/struktur/kliniken/innere-medizin/klinik-fuer-innere-medizin-i.html |
|---|---|
"ROR" |
https://ror.org/05emabm63 |
Funders
Funder type
University/education
University of Ulm (Germany) - Department of Internal Medicine I, Gastroenterology and Endocrinology
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 |
