Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/05/2005
Date assigned
08/07/2005
Last edited
31/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charles Haworth

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Papworth Hospital NHS Trust (UK)

Sponsor details

Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21849264

Publication citations

  1. 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.

Additional files

Editorial Notes