NCT00440375

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_4 type-2-diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
Last Updated

February 27, 2007

Status Verified

February 1, 2007

First QC Date

February 26, 2007

Last Update Submit

February 26, 2007

Conditions

Type 2 Diabetes MellitusObesityMenopause

Outcome Measures

Primary Outcomes (1)

  • metabolic bone markers before and after the intervention,

Secondary Outcomes (1)

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

Interventions

RosiglitazoneDRUG

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed type 2 diabetes mellitus
  • Postmenopausal period

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Berberoglu Z, Gursoy A, Bayraktar N, Yazici AC, Bascil Tutuncu N, Guvener Demirag N. Rosiglitazone decreases serum bone-specific alkaline phosphatase activity in postmenopausal diabetic women. J Clin Endocrinol Metab. 2007 Sep;92(9):3523-30. doi: 10.1210/jc.2007-0431. Epub 2007 Jun 26.

    PMID: 17595249DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Zehra Berberoglu

    The Society of Endocrinology and Metabolism of Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2007

First Posted

February 27, 2007

Study Start

June 1, 2005

Study Completion

March 1, 2006

Last Updated

February 27, 2007

Record last verified: 2007-02