A randomised trial of nurse led clinics to promote increased use of calcium with vitamin D supplements for fracture prevention in women over 70 years
ISRCTN | ISRCTN26118436 |
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DOI | https://doi.org/10.1186/ISRCTN26118436 |
Secondary identifying numbers | RCHA251 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 01/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Torgerson
Scientific
Scientific
University of York
Dept of Health Studies & Centre for Health Economics
Heslington
York
YO10 5DQ
United Kingdom
Phone | +44 (0)1904 434 129 |
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djt6@york.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | A randomised trial of nurse led clinics to promote increased use of calcium with vitamin D supplements for fracture prevention in women over 70 years |
Study objectives | To assess whether supplementation with calcium and cholecaliferol (vitamin D3) reduces the risk of fracture in women with one or more risk factors for fracture of the hip.randomised controlled trial |
Ethics approval(s) | Ethical approval for the study was obtained from the Northern and Yorkshire multicentre research ethics committee and relevant local research ethics committees. |
Health condition(s) or problem(s) studied | Injury, occupational diseases, poisoning: Musculoskeletal injury |
Intervention | Daily oral supplementation using 1000 mg calcium with 800 IU cholecaliferol and information leaflet on dietary calcium intake and prevention of falls, or leaflet only (control group). |
Intervention type | Other |
Primary outcome measure | All clinical fractures |
Secondary outcome measures | 1. Adherence to treatment 2. Falls 3. Quality of life (measured with the 12-item short form health survey [SF-12]) |
Overall study start date | 09/01/2001 |
Completion date | 03/01/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Female |
Target number of participants | 3314 |
Key inclusion criteria | 3314 women aged 70 and over with one or more risk factors for hip fracture: 1. Any previous fracture 2. Low body weight (less than 58 kg) 3. Smoker 4. Family history of hip fracture 5. Fair or poor self reported health |
Key exclusion criteria | 1. Cognitive impairment 2. A life expectancy of less than six months |
Date of first enrolment | 09/01/2001 |
Date of final enrolment | 03/01/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of York
York
YO10 5DQ
United Kingdom
YO10 5DQ
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
No information available
Results and Publications
Intention to publish date | |
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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 | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | 30/04/2005 | Yes | No | ||
Results article | 26/10/2005 | Yes | No |
Editorial Notes
01/09/2022: Internal review.