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Effects of Rosiglitazone on Bone in Postmenopausal Diabetic Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00440375
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : February 27, 2007
Information provided by:
Baskent University

Brief Summary:
The purpose of this study is to evaluate the effect of rosiglitazone on bone metabolism and to assess the association between the changes in bone turnover parameters and plasma cytokine levels in postmenopausal diabetic women

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Obesity Menopause Drug: Rosiglitazone Phase 4

Detailed Description:

Fifty-six obese, drug naive patients with type 2 diabetes mellitus were enrolled and completed the study. Twenty-six healthy subjects matched for age and body mass index (BMI) served as nondiabetic controls. All subjects were postmenopausal women with last menses at least 2 years. After the baseline measurements, all subjects were instructed to follow a weight-maintaining diet, based on ADA recommendations, and were also encouraged to walk or to jog at least 30 min daily. Subsequently, 28 of the diabetic subjects were randomly assigned to receive rosiglitazone (4 mg/day). Twenty-eight of diabetic subjects were on diet alone. The randomization procedure was based on a random sequence.

All subjects had a complete clinical examination, anthropometric measurements, and laboratory tests at baseline and at the end of the 12th week of the study. Laboratory investigations included assessment of: (i) glycemic control (HbA1c, fasting plasma glucose and insulin levels, and homeostasis model assessment (HOMA) index (22); (ii) serum bsALP and active human osteocalcin concentration (OCL) as markers of bone formation; (iii) urine deoxypyridinoline (DPD) as marker of bone resorption. Other non-specific bone markers including serum total ALP activity, urinary calcium (Ca) and phosphate (PO4) concentrations were also measured. Urine concentrations of DPD (nmol/L), Ca and PO4 (both in mmol/L) were corrected for their respective urine creatinine (Cr) concentrations in mmol/L (Urine DPD/Cr, Urine Ca/Cr and Urine PO4/Cr respectively). In addition, fasting blood samples were analyzed for plasma cytokine levels including IL-1β, IL-6 and TNF-α, and for haptoglobin levels.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : June 2005
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. metabolic bone markers before and after the intervention,

Secondary Outcome Measures :
  1. association between the changes in bone turnover parameters and plasma cytokine levels

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Newly diagnosed type 2 diabetes mellitus
  • Postmenopausal period

Exclusion Criteria:

  • Recent fracture or osteoporosis
  • Drugs that may affect calcium or bone metabolism or drugs known to interfere with cytokine release
  • Thyroid, parathyroid, pituitary, nutritional, inflammatory, hepatic, renal, or neoplastic disorders
  • Severe cardiovascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00440375

Sponsors and Collaborators
Baskent University
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Principal Investigator: Zehra Berberoglu The Society of Endocrinology and Metabolism of Turkey
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00440375    
Other Study ID Numbers: KA 05/74
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: February 27, 2007
Last Verified: February 2007
Additional relevant MeSH terms:
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Hypoglycemic Agents
Physiological Effects of Drugs