Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9518113
Study information
Scientific title
Acronym
Study hypothesis
To determine in an elderly female population who would best benefit from an intervention aimed at reducing the incidence of hip fracture
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Orthopaedics, rheumatology
Intervention
Clodronate/control
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Fragility fractures, particularly hip fracture
Secondary outcome measures
Not provided at time of registration
Overall trial start date
10/06/1996
Overall trial end date
01/12/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women aged 75 years or older willing to participate
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
5700
Participant exclusion criteria
Drugs and diseases likely to impair the efficacy of intervention or the interpretation of results
Recruitment start date
10/06/1996
Recruitment end date
01/12/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Human Metabolism & Clinical Biochemistry
Sheffield
S10 2RX
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Publication citations
-
Results
McCloskey EV, Beneton M, Charlesworth D, Kayan K, deTakats D, Dey A, Orgee J, Ashford R, Forster M, Cliffe J, Kersh L, Brazier J, Nichol J, Aropuu S, Jalava T, Kanis JA, Clodronate reduces the incidence of fractures in community-dwelling elderly women unselected for osteoporosis: results of a double-blind, placebo-controlled randomized study., J. Bone Miner. Res., 2007, 22, 1, 135-141, doi: 10.1359/jbmr.061008.