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Randomised trial of vitamin D and calcium for the secondary prevention of osteoporosis related fractures in the elderly
ISRCTN ISRCTN51647438
DOI 10.1186/ISRCTN51647438
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised trial of vitamin D and calcium for the secondary prevention of osteoporosis related fractures in the elderly
Scientific title
Acronym RECORD
Serial number at source G9706483
Study hypothesis 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
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Primary care
Participants - 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
Participants - 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
Anticipated start date 18/11/1998
Anticipated end date 30/04/2004
Status of trial Completed
Patient information material
Target number of participants 5250
Interventions Daily oral Vitamin D/Calcium/Vitamin D and calcium in combination/placebo
Primary outcome measure(s) 1. New fractures,
2. Cost per avoided new fracture
3. Quality of life gain
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Medical Research Council (UK)
Trial website
Publications 1. 2005 results in: http://www.ncbi.nlm.nih.gov/pubemd/15885294
2. 2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17702768
3. 2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19617604
4. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24401173
Contact name Prof  Adrian  Grant
  Address Health Services Research Unit
University of Aberdeen
Polwarth Building
Foresterhill
  City/town Aberdeen
  Zip/Postcode AB9 2ZD
  Country United Kingdom
  Tel +44 (0)1224 553908
  Fax +44 (0)1224 663087
  Email a.grant@adn.ac.uk
Sponsor Medical Research Council (MRC) (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Tel +44 (0)20 7636 5422
  Fax +44 (0)20 7436 6179
  Email clinical.trial@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk
Date applied 23/10/2000
Last edited 10/01/2014
Date ISRCTN assigned 23/10/2000
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