The Effect of Glitazone Treatment on Bone Marrow and Bone Marrow Cells
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Difference in Percent Change in Bone Mineral Density (BMD) From Baseline to 14 Weeks Between the Rosiglitazone Group and the Placebo Group
研究概览
简要总结
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:
- 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.
- The effect on bone turnover will be measured in blood- and urine samples at the same times.
- The effect on fat distribution will be evaluated by an MRI scan after treatment.
- The effect on bone marrow cells will be investigated bone marrow sampling immediately after treatment
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women age 60-75 with no rosiglitazone allergy
排除标准
- •Osteoporosis
- •Hyperthyroidism, untreated hypothyroidism, hyperparathyroidism
- •Treatment with bone active drugs
- •Low impact fracture
- •Heart disease
- •Kidney failure
- •Liver failure
- •Ineligibility for MRI-scan
- •Cancer within last 5 years
研究组 & 干预措施
Rosiglitazone
25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
干预措施: Rosiglitazone (Drug)
Placebo
25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
干预措施: Placebo pill (Drug)
结局指标
主要结局
Difference in Percent Change in Bone Mineral Density (BMD) From Baseline to 14 Weeks Between the Rosiglitazone Group and the Placebo Group
时间窗: BMD measured at baseline and after 14 weeks of treatment
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)
次要结局
- Difference in Percent Change in Bone Marrow Fat (Given by a Lipid to Water Ratio) in the Spine.(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(At baseline and after 14 weeks of treatment)
- Change in Gene Expression in Bone Marrow and Fat Cells(Before and after treatment)