A 52 Week Randomized, Double-Blind, Multicenter, Mechanistic Study with a 24 Week Open-Label Follow-Up to Evaluate the Effect of AVANDIA™ on Bone in Postmenopausal Women with Type 2 Diabetes Mellitus
- Conditions
- Effect of rosiglitazone on bone in postmenopausal women with type 2 diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2008-002301-38-EE
- Lead Sponsor
- GlaxoSmithKline Research and Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 226
1. Female, >55 to <80 years
2. >5 years menopausal
3. Type II diabetes mellitus diagnosis according to ADA, AACE, CDA, WHO/IDF
4. Prior antidiabetic therapy: Drug Naive (HbA1c < or = 9.0%); Prior Monotherapy on submaximal doses of metformin, sulfonylureas or full dose Januvia (HbA1c < or = 8.5%) OR Prior Monotherapy on greater than submaximal doses of metformin, sulfonylureas (HbA1c < or = 7.0%)
5. Weighs <300 lbs (136.4 kg)
6. Two or more vertebra (L1-L4) suitable for BMD measurement by DXA
7. BMD T-score >-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
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 (<6 months) history or clinical intervention for angina or mycardial infarction or is taking nitrates
6. Any stage of heart failure, i.e. NYHA class I-IV
7. Systolic BP >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>• % change in BMD at the femoral neck by DXA from Baseline to Week 52.<br>
- Secondary Outcome Measures
Name Time Method