Condition category
Musculoskeletal Diseases
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
10/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Adrian Grant

ORCID ID

Contact details

Health Services Research Unit
University of Aberdeen
Polwarth Building
Foresterhill
Aberdeen
AB9 2ZD
United Kingdom
+44 (0)1224 553908
a.grant@adn.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9706483

Study information

Scientific title

Acronym

RECORD

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

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Primary care

Intervention

Daily oral Vitamin D/Calcium/Vitamin D and calcium in combination/placebo

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. New fractures,
2. Cost per avoided new fracture
3. Quality of life gain

Secondary outcome measures

Not provided at time of registration

Overall trial start date

18/11/1998

Overall trial end date

30/04/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

5250

Participant 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

Recruitment start date

18/11/1998

Recruitment end date

30/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health Services Research Unit
Aberdeen
AB9 2ZD
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    Avenell A, Cook JA, Maclennan GS, Macpherson GC, Vitamin D supplementation to prevent infections: a sub-study of a randomised placebo-controlled trial in older people (RECORD trial, ISRCTN 51647438)., Age Ageing, 2007, 36, 5, 574-577, doi: 10.1093/ageing/afm091.

  2. Results

    Avenell A, Cook JA, MacLennan GS, McPherson GC, , Vitamin D supplementation and type 2 diabetes: a substudy of a randomised placebo-controlled trial in older people (RECORD trial, ISRCTN 51647438)., Age Ageing, 2009, 38, 5, 606-609, doi: 10.1093/ageing/afp109.

  3. Results

    MacLennan G, McDonald A, McPherson G, Treweek S, Avenell A, , Advance telephone calls ahead of reminder questionnaires increase response rate in non-responders compared to questionnaire reminders only: The RECORD phone trial., Trials, 2014, 15, 13, doi: 10.1186/1745-6215-15-13.

Additional files

Editorial Notes