A randomised double blind placebo controlled trial assessing the effect of once weekly risedronate on bone mineral density in adults with cystic fibrosis
- Conditions
- Cystic fibrosisNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN36453336
- Lead Sponsor
- Papworth Hospital NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
80 cystic fibrosis patients with low bone mineral density. Z =-1.0 at the spine or femoral neck
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone mineral density Z score at the lumbar spine or femoral neck
- Secondary Outcome Measures
Name Time Method ot provided at time of registration