|
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
|
|
|
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
|
Results:
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
|
|
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
|
22/07/2009
|
|
Date ISRCTN assigned
|
23/10/2000
|
