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NCT Number: NCT00609362

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

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Key information

Conditions

Change in Bone Mineral Density Change in Bone Marrow Fat Content

Age range

60 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Aarhus University Hospital

Aarhus, 8000 C, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rosiglitazone

Drug

one tablet of rosiglitazone 8 milligrams per day for 14 weeks

Other names: Avandia

Placebo pill

Drug

One encapsulated placebo pill a day for 14 weeks

Primary outcomes

  1. Difference in Percent Change in Bone Mineral Density (BMD) From Baseline to 14 Weeks Between the Rosiglitazone Group and the Placebo Group

    Time frame: 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)

Secondary outcomes

  1. Difference in Percent Change in Bone Marrow Fat (Given by a Lipid to Water Ratio) in the Spine.

    Time frame: Measured at baseline and after 14 weeks of treatment

    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)

  2. Difference in Percent Change in Level of C-terminal Telopeptide (CTx) Between the Rosiglitazone and Placebo Groups

    Time frame: At baseline and after 14 weeks of treatment

    C-terminal telopeptide is a marker of bone resorption. Its levels are measure in plasma using a chemiluminometric method (ECLIA).

  3. Change in Gene Expression in Bone Marrow and Fat Cells

    Time frame: Before and after treatment

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 7, 2008
Registry last updated
Apr 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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