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 |
| Protocol serial number | G9518113 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Fragility fractures, particularly hip fracture |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Human Metabolism & Clinical Biochemistry
Sheffield
S10 2RX
United Kingdom
S10 2RX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |