Randomised trial of vitamin D and calcium for the secondary prevention of osteoporosis related fractures in the elderly

ISRCTN ISRCTN51647438
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

Health Services Research Unit
University of Aberdeen
Polwarth Building
Foresterhill
Aberdeen
AB9 2ZD
United Kingdom

Phone +44 (0)1224 553908
Email a.grant@adn.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific title
Study acronymRECORD
Study objectives1. 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) studiedPrimary care
InterventionDaily oral Vitamin D/Calcium/Vitamin D and calcium in combination/placebo
Intervention typeOther
Primary outcome measure1. New fractures,
2. Cost per avoided new fracture
3. Quality of life gain
Secondary outcome measuresNot provided at time of registration
Overall study start date18/11/1998
Completion date30/04/2004

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants5250
Key inclusion criteria1. 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 criteria1. 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 enrolment18/11/1998
Date of final enrolment30/04/2004

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Health Services Research Unit
Aberdeen
AB9 2ZD
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email 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
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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