Risedronate for the prevention of bone loss after steroid therapy for a flare-up in inflammatory bowel disease
| ISRCTN | ISRCTN93280043 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93280043 |
| EudraCT/CTIS number | 2004-004325-10 |
| Secondary identifying numbers | ME/2005/2018; 2004-004325-10 |
- Submission date
- 16/11/2008
- Registration date
- 20/11/2008
- Last edited
- 06/10/2011
- 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
Prof Jonathan H Tobias
Scientific
Scientific
Academic Rheumatology
Avon Orthopaedic Centre
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
Study information
| Study design | Radonmised, double-blind, placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised controlled trial to evaluate whether a short course of once weekly risedronate prevents bone loss following high-dose steroid therapy for an acute exacerbation of inflammatory bowel disease |
| Study objectives | The hypothesis is based on the observation that osteoporosis occurs in patients with inflammatory bowel disease (IBD) and that detectable bone loss occurs after steroid treatment for only 8 weeks. Bisphosphonates are effective at treating bone loss but whether it is effective at preventing bone loss in this context is being addressed in this trial. |
| Ethics approval(s) | Gloucestershire Research Ethics Committee approved the trial in June 2005 (ref: 05/Q2005/74) |
| Health condition(s) or problem(s) studied | Inflammatory bowel disease (ulcerative colitis and Crohn's disease) |
| Intervention | All patients participating in the trial were given calcium and vitamin in the form of Cacit D3 effervescent granules (calcium 500 mg/Vitamin D 440IU) at a dose of one sachet daily. Patients were randomised to risedronate 35 mg weekly or a placebo. The total duration of intervention was 8 weeks and follow up was for the same 8 weeks in both arms. Participants were seen at baseline and then 8 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Risedronate |
| Primary outcome measure | The difference in percentage change in total hip (and sub-regions of the hip) and lumbar spine bone mineral density (BMD) measured by dual x-ray absorptiometry (DXA) 8 weeks apart between treatment groups (baseline is when corticosteroids start and week 8 at completion of the steroids). |
| Secondary outcome measures | 1. Do patients with ulcerative colitis and Crohn's disease have a differential response to steroid therapy or risedronate? 2. Change in markers of bone turnover (CTX for resorption and P1NP for formation) measured before steroids start (week -1), baseline and at week 8 3. Urinary steroid metabolites and cytokines measured from samples obtained at week -1 |
| Overall study start date | 01/10/2005 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Aged greater than or equal to 16 years, either sex 2. Ulcerative colitis and Crohn's disease 3. Experiencing a relapse 4. Requiring steroid therapy |
| Key exclusion criteria | 1. Aged under 16 years 2. Use of corticosteroids in the preceding 3 months 3. Evidence of osteoporosis (known vertebral fracture, T score less than -2.5) 4. Pregnant and lactating women 5. Women of childbearing age will be eligible provided they use reliable contraception 6. Bone active therapy within previous 12 months (excluding calcium and low dose vitamin D) 7. Previous treatment with a bisphosphonate at any time 8. Associated disorder which may influence bone metabolism 9. Lactose intolerance |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Rheumatology
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
University Hospitals Bristol NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Maria Palmer
Director of Research and Effectiveness Department
Bristol Royal Infirmary
Bristol
BS2 8HW
England
United Kingdom
"ROR" |
https://ror.org/04nm1cv11 |
|---|
Funders
Funder type
Industry
Procter and Gamble Pharmaceuticals (UK) - educational grant.
No information available
The funder had no input into the study design, recruitment or the analysis of the results.
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 | results | 01/03/2010 | Yes | No |
