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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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 design	Randomised controlled trial
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

Participant type(s)	Patient
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

Health Services Research Unit

Aberdeen
AB9 2ZD
United Kingdom

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

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

Intention to publish date
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

Output type	Details	Date created	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