Change in Bone Mineral Density Clinical Trial
Official title:
The Effect of Glitazone Treatment on Bone Marrow and Bone Marrow Cells
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:
1. The effect on bone marrow density will be examined by a bone scan prior to and after
treatment and again after 6 and 9 months.
2. The effect on bone turnover will be measured in blood- and urine samples at the same
times.
3. The effect on fat distribution will be evaluated by an MRI scan after treatment.
4. The effect on bone marrow cells will be investigated bone marrow sampling immediately
after treatment
5. The direct effect on fat will be examined by a biopsy immediately after treatment The
study hypothesis is that rosiglitazone treatment decreases bone mineral density and
increases bone marrow fat content. The causal molecular mechanisms will be investigated
from the bone marrow and fat samples
Status | Completed |
Enrollment | 57 |
Est. completion date | November 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 60 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Postmenopausal women age 60-75 with no rosiglitazone allergy Exclusion Criteria: - Osteoporosis - Diabetes - Hyperthyroidism, untreated hypothyroidism, hyperparathyroidism - Treatment with bone active drugs - Low impact fracture - Heart disease - Kidney failure - Liver failure - Anaemia - Ineligibility for MRI-scan - Cancer within last 5 years |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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) | BMD measured at baseline and after 14 weeks of treatment | No |
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) | Measured at baseline and after 14 weeks of treatment | No |
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). | At baseline and after 14 weeks of treatment | No |
Secondary | Change in Gene Expression in Bone Marrow and Fat Cells | Before and after treatment | No |
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