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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosiglitazone | Active Comparator | 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day |
|
| Placebo | Placebo Comparator | 25 women 60 to 75 years of age receiving placebo once a day for 14 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosiglitazone | Drug | one tablet of rosiglitazone 8 milligrams per day for 14 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | BMD measured at baseline and after 14 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torben Harsløf, Dr. | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8000 C | Denmark |
74 individuals were screened. 17 were screen failures due to exclusion criteria. 57 were randomized.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rosiglitazone | 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day |
| FG001 | Placebo | 25 women 60 to 75 years of age receiving placebo once a day for 14 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rosiglitazone | 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day |
| BG001 | Placebo | 25 women 60 to 75 years of age receiving placebo once a day for 14 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | Percent change from baseline | BMD measured at baseline and after 14 weeks of treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rosiglitazone | 25 women age 60 to 75 years receiving rosiglitazone 8 mg/day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Torben Harsløf, MD | University of Aarhus | +4589497681 | torbhars@rm.dk |
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| ID | Term |
|---|---|
| D000077154 | Rosiglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo pill | Drug | One encapsulated placebo pill a day for 14 weeks |
|
C-terminal telopeptide is a marker of bone resorption. Its levels are measure in plasma using a chemiluminometric method (ECLIA). |
| At baseline and after 14 weeks of treatment |
| Change in Gene Expression in Bone Marrow and Fat Cells | Before and after treatment |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | Percent change in LWR | Measured at baseline and after 14 weeks of treatment |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | Percent change from baseline | At baseline and after 14 weeks of treatment |
|
|
|
|
| Secondary | Change in Gene Expression in Bone Marrow and Fat Cells | Not Posted | Before and after treatment |
| 0 |
| 26 |
| 19 |
| 26 |
| EG001 | Placebo | 25 women 60 to 75 years of age receiving placebo once a day for 14 weeks | 0 | 27 | 15 | 27 |
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Hypercholesterolemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Tendinitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Edema | Cardiac disorders | Non-systematic Assessment |
|
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| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |