The Effect of Glitazone Treatment on Bone Marrow and Bone Marrow Cells

NCT ID: NCT00609362

Last Updated: 2011-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-11-30

Brief Summary

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

Conditions

Change in Bone Mineral Density; Change in Bone Marrow Fat Content

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Rosiglitazone

25 women age 60 to 75 years receiving rosiglitazone 8 mg/day

Group Type: ACTIVE_COMPARATOR

Rosiglitazone

Intervention Type: DRUG

one tablet of rosiglitazone 8 milligrams per day for 14 weeks

Placebo

25 women 60 to 75 years of age receiving placebo once a day for 14 weeks

Group Type: PLACEBO_COMPARATOR

Placebo pill

Intervention Type: DRUG

One encapsulated placebo pill a day for 14 weeks

Interventions

Rosiglitazone

one tablet of rosiglitazone 8 milligrams per day for 14 weeks

Intervention Type: DRUG

Placebo pill

One encapsulated placebo pill a day for 14 weeks

Intervention Type: DRUG

Other Intervention Names

Avandia

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Aarhus University Hospital

Principal Investigators

Torben Harsløf, Dr.

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

2007-223

Identifier Type: -

Identifier Source: org_study_id