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
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

Cystic Fibrosis Unit
Papworth Hospital NHS Trust
Papworth Everard
CB3 8RE
United Kingdom

Study information

Study designRandomised double blind placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedCystic fibrosis
InterventionOnce weekly risedronate or placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Risedronate
Primary outcome measureBone mineral density Z score at the lumbar spine or femoral neck
Secondary outcome measuresNot provided at time of registration
Overall study start date01/07/2005
Completion date31/07/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants80
Key inclusion criteria80 cystic fibrosis patients with low bone mineral density. Z ≤-1.0 at the spine or femoral neck
Key exclusion criteria1. 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 enrolment01/07/2005
Date of final enrolment31/07/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Cystic Fibrosis Unit
Papworth Everard
CB3 8RE
United Kingdom

Sponsor information

Papworth Hospital NHS Trust (UK)
Hospital/treatment centre

Papworth Everard
Cambridge
CB3 8RE
England
United Kingdom

ROR logo "ROR" https://ror.org/01qbebb31

Funders

Funder type

Industry

Proctor & Gamble Pharmaceuticals (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2011 Yes No