Effect of rosiglitazone on bone in postmenopausal women with type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: Avandia
Pharmaceutical Form: Over encapsulated tablet
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Trade Name: Glucophage
Pharmaceutical F
Sponsors
GlaxoSmithKline Research and Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female, >55 to 5 years menopausal 3. Type II diabetes mellitus diagnosis according to ADA, AACE, CDA, WHO/IDF 4. Prior antidiabetic therapy: Drug Naive (HbA1c -2.5 at femoral neck, lumbar spine and total hip 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: 1. Type I diabetes mellitus or history of Diabetic ketoacidosis 2. Renal or hepatic disease (clin. sig.) 3. Hepatocellular reaction, severa edema, or medically serious fluid event associated with TZD 4. Macular edema 5. Recent (160mmHg or diastolic BP >90mmHg while on antihypertensive 8. Hypersensitivity to TZDs, biguanides 9. Prior treatment with two or more oral antidiabetic agents, insulin or exenatide 10. Bilateral hip replacments 11. Concurrent diseases affecting bone metabolism 12. Active malabsortion syndrome 13. Serum calcium outside of the central lab ref range 14. Thyroid replacement therapy, serum TSH must be within range 15. Vitamin D deficiency 16. Previous tx with strontium, IV bisphosphonate, fluoride, hormones, calcineurin inhibitors or methotrexate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate mean percentage change in BMD at the femoral neck, as measured by DXA, from Baseline to Week 52 within the AVANDIA treatment group.;Secondary Objective: Bone mineral density of the hip and spine at months 0, 4, 7, 12 and 18. Measures of bone formation and resorption at months 0, 3, 7, 12, 16 and 18. Measures of integral, coritcal, trabecular and other bone parameters at the hip and spine at months 0, 52 and 76. Measures of sex hormones and calcium homeostasis at months 0, 12 and 18. Measures of clinical safety over time. ;Primary end point(s): To assess within the AVANDIA treatment group: • % change in BMD at the femoral neck by DXA from Baseline to Week 52. | — |
Countries
Estonia, Spain
Outcome results
None listed