Randomised trial of vitamin D and calcium for the secondary prevention of osteoporosis related fractures in the elderly
ISRCTN | ISRCTN51647438 |
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DOI | https://doi.org/10.1186/ISRCTN51647438 |
Secondary identifying numbers | G9706483 |
- Submission date
- 23/10/2000
- Registration date
- 23/10/2000
- Last edited
- 10/01/2014
- 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
Prof Adrian Grant
Scientific
Scientific
Health Services Research Unit
University of Aberdeen
Polwarth Building
Foresterhill
Aberdeen
AB9 2ZD
United Kingdom
Phone | +44 (0)1224 553908 |
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a.grant@adn.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 | Prevention |
Scientific title | |
Study acronym | RECORD |
Study objectives | 1. Daily oral Vitamin D or Calcium, or the two in combination, given to people aged 70 or over who have recently been successfully treated for a fracture likely to be related to osteoporosis, will decrease the incidence of subsequent fractures. 2. The cost of any effective regimen will be less than those associated with the fracture prevented |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Primary care |
Intervention | Daily oral Vitamin D/Calcium/Vitamin D and calcium in combination/placebo |
Intervention type | Other |
Primary outcome measure | 1. New fractures, 2. Cost per avoided new fracture 3. Quality of life gain |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 18/11/1998 |
Completion date | 30/04/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Both |
Target number of participants | 5250 |
Key inclusion criteria | 1. Aged 70 years or over (irrespective of sex) 2. Recent first proximal femoral or other appendicular fracture sustained in a fall or clinical vertebral fracture 3. Attending fracture clinic or hospital in-patient 4. Resident in UK 5. Able to comply with protocol (eg Mini-mental Score greater than 7) 6. Gives consent |
Key exclusion criteria | 1. Multiple or high energy transfer injury 2. Inability to walk prior to presenting fracture without the support of others 3. Suffering from known malignant disease 4. Contraindication to Calcium or Vitamin D 5. Current or recent treatment with more than 200iu daily of Vitamin D, Calcium, Fluoride, Diphosphonate or Calcitonin |
Date of first enrolment | 18/11/1998 |
Date of final enrolment | 30/04/2004 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Health Services Research Unit
Aberdeen
AB9 2ZD
United Kingdom
AB9 2ZD
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 |
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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 | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 07/05/2005 | Yes | No | |
Results article | results | 01/09/2007 | Yes | No | |
Results article | results | 01/09/2009 | Yes | No | |
Results article | results | 08/01/2014 | Yes | No |