Effects of Rosiglitazone on Bone in Postmenopausal Diabetic Women

This study has been completed.
Sponsor:
Information provided by:
Baskent University
ClinicalTrials.gov Identifier:
NCT00440375
First received: February 26, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Obesity
Menopause
Drug: Rosiglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Baskent University:

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

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

Estimated Enrollment: 82
Study Start Date: June 2005
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440375

Sponsors and Collaborators
Baskent University
Investigators
Principal Investigator: Zehra Berberoglu The Society of Endocrinology and Metabolism of Turkey
  More Information

No publications provided by Baskent University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00440375     History of Changes
Other Study ID Numbers: KA 05/74
Study First Received: February 26, 2007
Last Updated: February 26, 2007
Health Authority: Turkey: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014