Condition category
Musculoskeletal Diseases
Date applied
26/02/2002
Date assigned
26/02/2002
Last edited
06/09/2007
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 Judith Hsia

ORCID ID

Contact details

George Washington University
2150 Pennsylvania Ave NW
Washington DC
20037
United States of America
+1 202 004 5461
domjah@gwumc.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

Treatment

Patient information sheet

Condition

Osteopenia

Intervention

1. Placebo once a day, at bedtime (qhs)
2. Simvastatin 20 mg qhs
3. Simvastatin 40 mg qhs

Intervention type

Drug

Phase

Not Specified

Drug names

Simvastatin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2001

Overall trial end date

01/05/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with osteopenia
2. Not taking oestrogen
3. Selective oestrogen receptor modulators
4. Bisphosphonates
5. Calcitonin
6. 3-hydroxy-3-methylglutaryl coenzyme A (HMG-coA) reductase inhibitors

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

24

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/2001

Recruitment end date

01/05/2001

Locations

Countries of recruitment

United States of America

Trial participating centre

George Washington University
Washington DC
20037
United States of America

Sponsor information

Organisation

George Washington University (USA)

Sponsor details

2150 Pennsylvania Ave NW
Washington DC
20037
United States of America

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Merck & Co. Inc. (USA) - unrestricted grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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 in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=11879528

Publication citations

  1. Results

    Hsia J, Morse M, Levin V, Effect of simvastatin on bone markers in osteopenic women: a placebo-controlled, dose-ranging trial [ISRCTN85429598]., BMC Musculoskelet Disord, 2002, 3, 7.

Additional files

Editorial Notes