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ISRCTN
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ISRCTN36453336
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ClinicalTrials.gov identifier
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Public title
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A randomised double blind placebo controlled trial assessing the effect of once weekly risedronate on bone mineral density in adults with cystic fibrosis
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Scientific title
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Acronym
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N/A
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Serial number at source
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P00961
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Study hypothesis
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To assess the efficacy, tolerability and safety of the bone-sparing treatment Risedronate, in adult Cystic Fibrosis patients with low bone mineral density
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised double blind placebo controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cystic fibrosis
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Participants - inclusion criteria
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80 cystic fibrosis patients with low bone mineral density. Z ≤-1.0 at the spine or femoral neck
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Participants - exclusion criteria
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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
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Anticipated start date
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01/07/2005
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Anticipated end date
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31/07/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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80
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Interventions
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Once weekly risedronate or placebo
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Primary outcome measure(s)
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Bone mineral density Z score at the lumbar spine or femoral neck
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Proctor & Gamble Pharmaceuticals (UK)
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Trial website
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Publications
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Contact name
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Dr
Charles
Haworth
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Address
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Cystic Fibrosis Unit
Papworth Hospital NHS Trust
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City/town
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Papworth Everard
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Zip/Postcode
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CB3 8RE
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Country
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United Kingdom
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Sponsor
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Papworth Hospital NHS Trust (UK)
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Address
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Papworth Everard
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City/town
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Cambridge
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Zip/Postcode
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CB3 8RE
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Country
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United Kingdom
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Date applied
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16/05/2005
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Last edited
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16/09/2009
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Date ISRCTN assigned
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08/07/2005
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