The effect of glitazone-treatment on bone turn-over and bone marrow cells

• Conditions: We want to investigate if rosiglitazone treatment can induce bone loss in humans; MedDRA version: 9.1Level: LLTClassification code 10031289Term: Osteoporosis, unspecified

• Registration Number: EUCTR2007-004714-14-DK
• Lead Sponsor: Aarhus University Hospital, Aarhus Sygehus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

-Female
-Postmenopausal as defined by 2 years menopause
-Age 60-75
-Informed conscent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Osteoporosis (T-score<-2,5 in hip or lumbar spine or previous low impact fractures except fracture of fingers, toes, face, ribs, clavicle)
-Endocrinological disease
-Treatment with bone active drugs: Hormone replacement therapy within last two years, antiosteoporotic treatment, peroral or intravenous corticosteroidhormone treatment equivalent to more than 1g of prednisolone within last year, antidiabetic treatment.
-Congestive or ischaemic heart disease
-Ongoin malignant disease or malignant disease within last 5 years except basocellular carcinoma of the skin.
-Anaemia 8p-hemoglobin < lower normal level)
-Renal disease (p-creatinine > upper normal level)
-Liver disease (transaminases > 2 x upper normal level, alkaline phosphatase > upper normal level)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if 14 weeks of rosiglitazone treatment can induce bone loss, as evaluated by DXA-scans;Primary end point(s): To investigate if 14 weeks of rosiglitazone treatment can induce bone loss, as evaluated by DXA-scans;Secondary Objective: - To investigate the effect on bone turnover by measuring biochemical markers of bone turnover in blood and urine before and after treatment.<br>- To investigate the effect on the expression of osteoblast- and adipocyte-specifik markers in bone marrow.<br>- To investigate the effect on geneekspression in preosteoblasts and adipocytes from bone marrow and adipocytes from subcutaneous adipose tissue.<br>- To investigate the effect on bone marrow fat content and peripheral fat distribution as measured by MR_scans.