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Sponsored by: |
University of Aarhus |
Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00609362 |
Osteoporosis is a generalised bone disease leading to an increased risk of fractures. The disease is caused partly by environmental and partly by genetic factors. It is well known that the fat content of the bone marrow is increased in osteoporotic patients. Animal studies suggest that stimulation of bone marrow stem cells through the molecule PPARgamma with the drug rosiglitazone converts the stem cells to fat cells instead of bone cells thereby decreasing bone strength. In a single study healthy volunteers were treated with rosiglitazone for 14 weeks and had a decrease in bone mineral density.
In the present study we wish to investigate the effect of this treatment on bone and fat tissue. 25 women above the age of 60 will be treated with rosiglitazone 8 mg/day for 14 weeks and compared with 25 women receiving placebo.
The effect will be evaluated as follows:
Condition | Intervention | Phase |
Change in Bone Mineral Density Change in Bone Marrow Fat Content |
Drug: Rosiglitazone Drug: Placebo pill |
Phase II |
MedlinePlus related topics: | Minerals |
Drug Information available for: | Rosiglitazone Rosiglitazone Maleate |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | The Effect of Glitazone Treatment on Bone Marrow and Bone Marrow Cells |
Estimated Enrollment: | 50 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Rosiglitazone: Active Comparator
25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
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Drug: Rosiglitazone
one tablet of rosiglitazone 8 milligrams per day for 14 weeks
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Placebo: Placebo Comparator
25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
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Drug: Placebo pill
One encapsulated placebo pill a day for 14 weeks
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Ages Eligible for Study: | 60 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Torben Harsløf, Dr | +4589497681 | torben.harslof@ki.au.dk |
Contact: bente L Langdahl, Dr., Ph.D. | +4589497678 | bente.langdahl@as.aaa.dk |
Denmark | |||||
Aarhus University Hospital | Recruiting | ||||
Aarhus, Denmark, 8000 C | |||||
Contact: Torben Harsløf, Dr +4589497681 torben.harslof@ki.au.dk | |||||
Contact: Bente L Langdahl, Dr., Ph.D. +4589497678 bente.langdahl@as.aaa.dk | |||||
Principal Investigator: Torben Harsløf, Dr |
University of Aarhus |
Principal Investigator: | Torben Harsløf, Dr. | Aarhus University Hospital |
Responsible Party: | Aarhus University Hospital ( Bente Langdahl ) |
Study ID Numbers: | 2007-223 |
First Received: | January 24, 2008 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00609362 |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
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