A Phase 2 interventional study of Rosiglitazone and Placebo pill in Change in Bone Mineral Density and Change in Bone Marrow Fat Content, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to female participants aged 60 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-27.
Sponsored by University of Aarhus · Phase 2, Interventional, and Basic science
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:
University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
Drug: Rosiglitazone
25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
Drug: Placebo pill
one tablet of rosiglitazone 8 milligrams per day for 14 weeks
Also known as: Avandia
One encapsulated placebo pill a day for 14 weeks
Difference in Percent Change in Bone Mineral Density (BMD) From Baseline to 14 Weeks Between the Rosiglitazone Group and the Placebo Group
Difference in percent change in bone mineral density (BMD) from baseline to 14 weeks between the rosiglitazone group and the placebo group. BMD was assesed using dual x-ray absorptiometry (DXA)
Time frame: BMD measured at baseline and after 14 weeks of treatment
Difference in Percent Change in Bone Marrow Fat (Given by a Lipid to Water Ratio) in the Spine.
Bone marrow fat was measured using MRI spectroscopy providing a measure of bone marrow fat as a ratio to bone marrow water, the lipid-water ratio (LWR)
Time frame: Measured at baseline and after 14 weeks of treatment
Difference in Percent Change in Level of C-terminal Telopeptide (CTx) Between the Rosiglitazone and Placebo Groups
C-terminal telopeptide is a marker of bone resorption. Its levels are measure in plasma using a chemiluminometric method (ECLIA).
Time frame: At baseline and after 14 weeks of treatment
Change in Gene Expression in Bone Marrow and Fat Cells
Time frame: Before and after treatment
Recruitment commenced january 2008 and ended february 2009. Participants were recruited by ads in local papers and called our osteoporosis clinic. 179 called and after a course description 150 were sent information. After having read that 74 paid a visit to the clinic.
| Milestone | Rosiglitazone | Placebo |
|---|---|---|
| Started | 29 | 28 |
| Completed | 26 | 27 |
| Not completed | 3 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Adverse event | 1 | 0 |
Difference in percent change in bone mineral density (BMD) from baseline to 14 weeks between the rosiglitazone group and the placebo group. BMD was assesed using dual x-ray absorptiometry (DXA)
| Percent change from baseline | Rosiglitazone | Placebo |
|---|---|---|
| Difference in Percent Change in Bone Mineral Density (BMD) From Baseline to 14 Weeks Between the Rosiglitazone Group and the Placebo Group | -1.3 ± 3.1 | 0.3 ± 2.9 |
Bone marrow fat was measured using MRI spectroscopy providing a measure of bone marrow fat as a ratio to bone marrow water, the lipid-water ratio (LWR)
| Percent change in LWR | Rosiglitazone | Placebo |
|---|---|---|
| Difference in Percent Change in Bone Marrow Fat (Given by a Lipid to Water Ratio) in the Spine. | -13.5 ± 5.5 | 6.8 ± 24.4 |
C-terminal telopeptide is a marker of bone resorption. Its levels are measure in plasma using a chemiluminometric method (ECLIA).
| Percent change from baseline | Rosiglitazone | Placebo |
|---|---|---|
| Difference in Percent Change in Level of C-terminal Telopeptide (CTx) Between the Rosiglitazone and Placebo Groups | 20.4 ± 38.6 | -7.1 ± 24.4 |
Results for this outcome have not been posted.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rosiglitazone | — | 0/26 (0%) | 19/26 (73.1%) |
| Placebo | — | 0/27 (0%) | 15/27 (55.6%) |
| Event | Rosiglitazone | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 6/26 | 4/27 |
| EdemaCardiac disorders | 6/26 | 2/27 |
| ColdRespiratory, thoracic and mediastinal disorders | 4/26 | 2/27 |
| HypercholesterolemiaMetabolism and nutrition disorders | 4/26 | 2/27 |
| TendinitisMusculoskeletal and connective tissue disorders | 2/26 | 1/27 |
| DiarrheaGastrointestinal disorders | 1/26 | 2/27 |
| FallMusculoskeletal and connective tissue disorders | 0/26 | 2/27 |
| Age, Categorical(Participants) | Rosiglitazone | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 16 | 31 |
| >=65 years | 14 | 12 | 26 |
| Age Continuous(years) | Rosiglitazone | Placebo | Total |
|---|---|---|---|
| Mean | 65.1 ± 3.5 | 65.3 ± 4.3 | 65.2 ± 3.8 |
| Sex: Female, Male(Participants) | Rosiglitazone | Placebo | Total |
|---|---|---|---|
| Female | 29 | 28 | 57 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Rosiglitazone | Placebo | Total |
|---|---|---|---|
| Denmark | 29 | 28 | 57 |
This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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University of Aarhus