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

This study is currently recruiting participants.
Verified by University of Aarhus, August 2008

Sponsored by: University of Aarhus
Information provided by: University of Aarhus
ClinicalTrials.gov Identifier: NCT00609362
  Purpose

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

Condition Intervention Phase
Change in Bone Mineral Density
Change in Bone Marrow Fat Content
Drug: Rosiglitazone
Drug: Placebo pill
Phase II

MedlinePlus related topics:   Minerals   

Drug Information available for:   Rosiglitazone    Rosiglitazone Maleate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:   The Effect of Glitazone Treatment on Bone Marrow and Bone Marrow Cells

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Change in bone mineral density [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in bone marrow fat content [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]
  • change in biochemical markers of bone turnover [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]
  • Change in gene expression in bone marrow and fat cells [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:   50
Study Start Date:   January 2008
Estimated Study Completion Date:   January 2010
Estimated Primary Completion Date:   January 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Rosiglitazone: Active Comparator
25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
Drug: Rosiglitazone
one tablet of rosiglitazone 8 milligrams per day for 14 weeks
Placebo: Placebo Comparator
25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
Drug: Placebo pill
One encapsulated placebo pill a day for 14 weeks

  Eligibility
Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609362

Contacts
Contact: Torben Harsløf, Dr     +4589497681     torben.harslof@ki.au.dk    
Contact: bente L Langdahl, Dr., Ph.D.     +4589497678     bente.langdahl@as.aaa.dk    

Locations
Denmark
Aarhus University Hospital     Recruiting
      Aarhus, Denmark, 8000 C
      Contact: Torben Harsløf, Dr     +4589497681     torben.harslof@ki.au.dk    
      Contact: Bente L Langdahl, Dr., Ph.D.     +4589497678     bente.langdahl@as.aaa.dk    
      Principal Investigator: Torben Harsløf, Dr            

Sponsors and Collaborators
University of Aarhus

Investigators
Principal Investigator:     Torben Harsløf, Dr.     Aarhus University Hospital    
  More Information


Responsible Party:   Aarhus University Hospital ( Bente Langdahl )
Study ID Numbers:   2007-223
First Received:   January 24, 2008
Last Updated:   August 11, 2008
ClinicalTrials.gov Identifier:   NCT00609362
Health Authority:   Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
BMD  
Rosiglitazone  
Bone marrow fat  

Study placed in the following topic categories:
Rosiglitazone

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 03, 2008




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