Effect of simvastatin on bone markers in osteopenic women: a placebo-controlled, dose-ranging trial
| ISRCTN | ISRCTN85429598 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85429598 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/02/2002
- Registration date
- 26/02/2002
- Last edited
- 06/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Judith Hsia
Scientific
Scientific
George Washington University
2150 Pennsylvania Ave NW
Washington DC
20037
United States of America
| Phone | +1 202 004 5461 |
|---|---|
| domjah@gwumc.edu |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Osteopenia |
| Intervention | 1. Placebo once a day, at bedtime (qhs) 2. Simvastatin 20 mg qhs 3. Simvastatin 40 mg qhs |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Simvastatin |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2001 |
| Overall study end date | 01/05/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 24 |
| 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 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
Study participating centre
George Washington University
Washington DC
20037
United States of America
20037
United States of America
Sponsor information
George Washington University (USA)
University/education
University/education
2150 Pennsylvania Ave NW
Washington DC
20037
United States of America
"ROR" |
https://ror.org/00y4zzh67 |
|---|
Funders
Funder type
Industry
Merck & Co. Inc. (USA) - unrestricted grant
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/01/2002 | Yes | No |
