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

This study has been completed.

Study NCT00609362 Information provided by University of Aarhus

First Received on January 24, 2008. Last Updated on March 29, 2011 History of Changes

Results First Received: February 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Basic Science
Conditions:	Change in Bone Mineral Density Change in Bone Marrow Fat Content
Interventions:	Drug: Rosiglitazone Drug: Placebo pill

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment commenced january 2008 and ended february 2009. Participants were recruited by ads in local papers and called our osteoporosis clinic. 179 called and after a course description 150 were sent information. After having read that 74 paid a visit to the clinic.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
74 individuals were screened. 17 were screen failures due to exclusion criteria. 57 were randomized.

Reporting Groups

	Description
Rosiglitazone	25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
Placebo	25 women 60 to 75 years of age receiving placebo once a day for 14 weeks

Participant Flow: Overall Study

	Rosiglitazone	Placebo
STARTED	29	28
COMPLETED	26	27
NOT COMPLETED	3	1
Withdrawal by Subject	2	1
Adverse Event	1	0

Baseline Characteristics

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Reporting Groups

	Description
Rosiglitazone	25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
Placebo	25 women 60 to 75 years of age receiving placebo once a day for 14 weeks

Baseline Measures

	Rosiglitazone	Placebo	Total
Number of Participants [units: participants]	29	28	57
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	15	16	31
>=65 years	14	12	26
Age [units: years] Mean ± Standard Deviation	65.1 ± 3.5	65.3 ± 4.3	65.2 ± 3.8
Gender [units: participants]
Female	29	28	57
Male	0	0	0
Region of Enrollment [units: participants]
Denmark	29	28	57

Outcome Measures

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1. Primary:

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 ]

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2. Secondary:

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 ]

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3. Secondary:

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 ]

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4. Secondary:

Change in Gene Expression in Bone Marrow and Fat Cells [ Time Frame: Before and after treatment ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Torben Harsløf, MD
Organization: University of Aarhus
phone: +4589497681
e-mail: torbhars@rm.dk

No publications provided

Responsible Party:	Bente Langdahl, Aarhus University Hospital
ClinicalTrials.gov Identifier:	NCT00609362 History of Changes
Other Study ID Numbers:	2007-223
Study First Received:	January 24, 2008
Results First Received:	February 17, 2011
Last Updated:	March 29, 2011
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics