Condition category
Musculoskeletal Diseases
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
12/09/2007
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

Dr EV McCloskey

ORCID ID

Contact details

Department of Human Metabolism & Clinical Biochemistry
University of Sheffield Medical School
Beech Hill Road
Sheffield
S10 2RX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9518113

Study information

Scientific title

Acronym

Study hypothesis

To determine in an elderly female population who would best benefit from an intervention aimed at reducing the incidence of hip fracture

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

Not specified

Trial type

Prevention

Patient information sheet

Condition

Orthopaedics, rheumatology

Intervention

Clodronate/control

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Fragility fractures, particularly hip fracture

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/06/1996

Overall trial end date

01/12/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 75 years or older willing to participate

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

5700

Participant exclusion criteria

Drugs and diseases likely to impair the efficacy of intervention or the interpretation of results

Recruitment start date

10/06/1996

Recruitment end date

01/12/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Human Metabolism & Clinical Biochemistry
Sheffield
S10 2RX
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

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17042717

Publication citations

  1. Results

    McCloskey EV, Beneton M, Charlesworth D, Kayan K, deTakats D, Dey A, Orgee J, Ashford R, Forster M, Cliffe J, Kersh L, Brazier J, Nichol J, Aropuu S, Jalava T, Kanis JA, Clodronate reduces the incidence of fractures in community-dwelling elderly women unselected for osteoporosis: results of a double-blind, placebo-controlled randomized study., J. Bone Miner. Res., 2007, 22, 1, 135-141, doi: 10.1359/jbmr.061008.

Additional files

Editorial Notes