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
                                        Scientific
                                                Department of Human Metabolism & Clinical Biochemistry
University of Sheffield Medical School
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
                                                
Study information
| Study design | Randomised controlled trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Not specified | 
| Study type | Prevention | 
| Scientific title | |
| Study objectives | To 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) studied | Orthopaedics, rheumatology | 
| Intervention | Clodronate/control | 
| Intervention type | Other | 
| Primary outcome measure | Fragility fractures, particularly hip fracture | 
| Secondary outcome measures | Not provided at time of registration | 
| Overall study start date | 10/06/1996 | 
| Completion date | 01/12/2002 | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Senior | 
| Sex | Female | 
| Target number of participants | 5700 | 
| Key inclusion criteria | Women aged 75 years or older willing to participate | 
| Key exclusion criteria | Drugs and diseases likely to impair the efficacy of intervention or the interpretation of results | 
| Date of first enrolment | 10/06/1996 | 
| Date of final enrolment | 01/12/2002 | 
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
                                            Department of Human Metabolism & Clinical Biochemistry
                                        
                                        
                                            
                                            Sheffield
S10 2RX
United Kingdom
                                    S10 2RX
United Kingdom
Sponsor information
                                            Medical Research Council (MRC) (UK)
Research council
                                        Research council
                                                20 Park Crescent
London
W1B 1AL
United Kingdom
                                                
| Phone | +44 (0)20 7636 5422 | 
|---|---|
| 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
                                            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 share | No | 
| IPD sharing plan summary | Not provided at time of registration | 
| Publication and dissemination plan | Not 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 | 

