Cystic fibrosis Nutritional, Metabolic, Endocrine Cystic fibrosis
Conditions
Interventions
Once weekly risedronate or placebo
Sponsors
Papworth Hospital NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 80 cystic fibrosis patients with low bone mineral density. Z =-1.0 at the spine or femoral neck
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density Z score at the lumbar spine or femoral neck | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed