The effect of clodronate on the incidence of hip fracture and consequences for health and costs

ISRCTN ISRCTN39259790
DOI https://doi.org/10.1186/ISRCTN39259790
Secondary identifying numbers G9518113
Submission date
25/10/2000
Registration date
25/10/2000
Last edited
12/09/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr EV McCloskey
Scientific

Department of Human Metabolism & Clinical Biochemistry
University of Sheffield Medical School
Beech Hill Road
Sheffield
S10 2RX
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study objectivesTo determine in an elderly female population who would best benefit from an intervention aimed at reducing the incidence of hip fracture
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOrthopaedics, rheumatology
InterventionClodronate/control
Intervention typeOther
Primary outcome measureFragility fractures, particularly hip fracture
Secondary outcome measuresNot provided at time of registration
Overall study start date10/06/1996
Completion date01/12/2002

Eligibility

Participant type(s)Patient
Age groupSenior
SexFemale
Target number of participants5700
Key inclusion criteriaWomen aged 75 years or older willing to participate
Key exclusion criteriaDrugs and diseases likely to impair the efficacy of intervention or the interpretation of results
Date of first enrolment10/06/1996
Date of final enrolment01/12/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Human Metabolism & Clinical Biochemistry
Sheffield
S10 2RX
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

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 01/01/2007 Yes No