A randomised double blind placebo controlled trial assessing the effect of once weekly risedronate on bone mineral density in adults with cystic fibrosis
ISRCTN | ISRCTN36453336 |
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DOI | https://doi.org/10.1186/ISRCTN36453336 |
Secondary identifying numbers | P00961 |
- Submission date
- 16/05/2005
- Registration date
- 08/07/2005
- Last edited
- 31/07/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Charles Haworth
Scientific
Scientific
Cystic Fibrosis Unit
Papworth Hospital NHS Trust
Papworth Everard
CB3 8RE
United Kingdom
Study information
Study design | Randomised double blind placebo controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | To assess the efficacy, tolerability and safety of the bone-sparing treatment Risedronate, in adult Cystic Fibrosis patients with low bone mineral density |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Cystic fibrosis |
Intervention | Once weekly risedronate or placebo |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Risedronate |
Primary outcome measure | Bone mineral density Z score at the lumbar spine or femoral neck |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/07/2005 |
Completion date | 31/07/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 80 |
Key inclusion criteria | 80 cystic fibrosis patients with low bone mineral density. Z ≤-1.0 at the spine or femoral neck |
Key exclusion criteria | 1. Breast feeding 2. Pregnancy or desire to become pregnant within three years 3. Transplant listed patients or transplant recipients 4. Previous gastroscopy proven oesophageal abnormalities 5. Renal impairment (patients with an elevated serum creatinine at the screening visit will have a creatinine clearance performed - a level over 30 ml/min will enable participation) 6. Hypocalcaemia at the screening visit (using serum corrected calcium) 7. Previous prescription of bone active drugs (bisphosphonates, hormone replacement therapy [does not include the oral contraceptive pill], raloxifene, calcitriol, calcitonin, teriparatide) 8. Biochemical evidence of vitamin D deficiency at the screening visit (25-hydroxyvitamin D level <10 ng/ml and an elevated parathyroid hormone [PTH]) 9. Long term oral corticosteroid use (defined as daily oral corticosteroid use for >6 weeks at the time of recruitment or the likelihood of requiring prolonged oral corticosteroid use at the time of recruitment) 10. Previous poor clinic attendance or previous poor adherence 11. Pre-terminal illness or other serious concomitant illness |
Date of first enrolment | 01/07/2005 |
Date of final enrolment | 31/07/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cystic Fibrosis Unit
Papworth Everard
CB3 8RE
United Kingdom
CB3 8RE
United Kingdom
Sponsor information
Papworth Hospital NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Papworth Everard
Cambridge
CB3 8RE
England
United Kingdom
https://ror.org/01qbebb31 |
Funders
Funder type
Industry
Proctor & Gamble Pharmaceuticals (UK)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/12/2011 | Yes | No |