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
Protocol serial number	P00961
Sponsor	Papworth Hospital NHS Trust (UK)
Funder	Proctor & Gamble Pharmaceuticals (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Charles Haworth
Scientific

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

Primary study design	Interventional
Study design	Randomised double blind placebo controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cystic fibrosis
Intervention	Once weekly risedronate or placebo
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Risedronate
Primary outcome measure(s)	Bone mineral density Z score at the lumbar spine or femoral neck
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/2008

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	80
Key inclusion criteria	80 cystic fibrosis patients with low bone mineral density. Z ≤-1.0 at the spine or femoral neck
Key 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
Date of first enrolment	01/07/2005
Date of final enrolment	31/07/2008

Cystic Fibrosis Unit

Papworth Everard
CB3 8RE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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