Effects of Rosiglitazone on Bone in Postmenopausal Diabetic Women

February 26, 2007 updated by: Baskent University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

82

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
metabolic bone markers before and after the intervention,

Secondary Outcome Measures

Outcome Measure
association between the changes in bone turnover parameters and plasma cytokine levels

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Investigators

  • Principal Investigator: Zehra Berberoglu, The Society of Endocrinology and Metabolism of Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

February 26, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (ESTIMATE)

February 27, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 27, 2007

Last Update Submitted That Met QC Criteria

February 26, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA 05/74

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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