Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P00961
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cystic fibrosis
Intervention
Once weekly risedronate or placebo
Intervention type
Drug
Phase
Not Specified
Drug names
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 trial start date
01/07/2005
Overall trial end date
31/07/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
80 cystic fibrosis patients with low bone mineral density. Z ≤-1.0 at the spine or femoral neck
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant 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
Recruitment start date
01/07/2005
Recruitment end date
31/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cystic Fibrosis Unit
Papworth Everard
CB3 8RE
United Kingdom
Funders
Funder type
Industry
Funder name
Proctor & Gamble Pharmaceuticals (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21849264
Publication citations
-
Results
Haworth CS, Sharples L, Hughes V, Elkin SL, Hodson ME, Conway SP, Etherington C, Elborn JS, Rendall J, Wheaton E, Kadri E, Elliott J, Barker HC, Bearcroft PW, Hlaing T, Compston JE, Multicentre trial of weekly risedronate on bone density in adults with cystic fibrosis., J. Cyst. Fibros., 2011, 10, 6, 470-476, doi: 10.1016/j.jcf.2011.07.007.