We want to investigate if rosiglitazone treatment can induce bone loss in humans MedDRA version: 9.1 Level: LLT Classification code 10031289 Term: Osteoporosis, unspecified
Conditions
Interventions
Trade Name: Avandia
Pharmaceutical Form: Coated tablet
INN or Proposed INN: ROSIGLITAZONE MALEATE
CAS Number: 155141290
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Aarhus University Hospital, Aarhus Sygehus
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: -Osteoporosis (T-score upper normal level) -Liver disease (transaminases > 2 x upper normal level, alkaline phosphatase > upper normal level)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - To investigate the effect on the expression of osteoblast- and adipocyte-specifik markers in bone marrow. - To investigate the effect on geneekspression in preosteoblasts and adipocytes from bone marrow and adipocytes from subcutaneous adipose tissue. - To investigate the effect on bone marrow fat content and peripheral fat distribution as measured by MR_scans. | — |
Countries
Denmark
Outcome results
None listed