Phase 4
Completed N=226
Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health
Source: ClinicalTrials.gov NCT00679939 ↗Enrolled (actual)
226
Serious AEs
3.1%
Results posted
Mar 2011
Primary outcomePrimary: Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52 — -1.24 percent change
Summary
The purpose of this study is to determine the effects of rosiglitazone on the bone in postmenopausal women with type 2 diabetes mellitus
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52 |
-1.24 | — |
| PRIMARY Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 76+10 Days |
-1.91; 0.31 | — |
| PRIMARY Adjusted Percent Change in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) From Week 52 +10 Days to Week 76+10 Days |
-0.07; -0.02 | — |
| SECONDARY Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 |
-1.24; 0.72; -0.77; -0.38; -0.21; -0.78 | — |
| SECONDARY Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+10 Days to Week 76 + 10 Days |
-0.07; -0.02; 0.40; -0.13; -0.02; -0.68 | — |
| SECONDARY Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+30 Days to Week 76 + 30 Days |
-0.27; -0.25; 0.00; -0.27; -0.17; -0.47 | — |
| SECONDARY Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 |
-15.2; -29.7; -12.3; -27.3; -9.3; -24.8 | — |
| SECONDARY Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 |
-5.6; 4.3; -2.0; 8.0; 1.8; 11.8 | — |
| SECONDARY Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 |
11.3; -7.8; 18.1; -2.3; 25.4; 3.7 | — |
| SECONDARY Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76 |
-31.2; 2.2; -26.7; 8.4; -21.9; 14.9 | — |
| SECONDARY Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 |
-27.9; -15.9; -24.7; -12.2; -21.4; -8.4 | — |
| SECONDARY Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76 |
-4.7; -7.7; 0.1; -3.2; 5.1; 1.5 | — |
| SECONDARY Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 |
-16.5; -25.9; -12.0; -22.0; -7.2; -17.8 | — |
| SECONDARY Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76 |
-13.2; -1.7; -7.4; 4.3; -1.3; 10.7 | — |
| SECONDARY Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 |
-17.0838; -31.4166; -3.453; -17.280; 12.4189; -0.2292 | — |
| SECONDARY Percent Change in Serum Estradiol From Week 52 to Week 76 |
-15.2056; 29.3058; 0.513; 50.823; 19.1447; 75.9217 | — |
| SECONDARY Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 |
14.1569; -5.8206; 19.689; 1.044; 25.4897; 8.4082 | — |
| SECONDARY Percent Change in Total Testosterone From Week 52 to Week 76 |
-29.0307; -13.9923; -24.373; -7.102; -19.4104; 0.3411 | — |
| SECONDARY Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 |
-9.9964; 2.5725; -5.940; 6.266; 1.7006; 10.0934 | — |
| SECONDARY Percent Change in Free Testosterone From Week 52 to Week 76 |
3.1109; -6.9549; 8.993; -3.537; 15.2100; 0.0073 | — |
| SECONDARY Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 |
33.2608; 4.3929; 37.563; 8.146; 42.0049; 12.0349 | — |
| SECONDARY Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76 |
-27.0129; -3.9036; -24.624; -0.825; -22.1566; 2.3517 | — |
Eligibility Criteria
Inclusion Criteria
- Female, >55 to 5 years menopausal
- Type 2 Diabetes Mellitus (T2DM) diagnosis according to American Diabetes Association (ADA), American Association of Clinical Endocrinologists (AACE), Canadian Diabetes Association (CDA), World Health Organization/International Diabetes Federation (WHO/IDF)
- Drug-naïve (HbA1c submaximal doses of metformin (>1000mg) or sulfonylureas (>5mg Glyburide, >10mg Glipizide or >8mg glimepiride) (HbA1c -2.5 at femoral neck, lumbar spine and total hip
Exclusion Criteria
- Type 1 Diabetes Mellitus (T1DM) or history of diabetic ketoacidosis (DKA)
- Renal or hepatic disease (clinically significant)
- Hepatocellular reaction, severe edema, or medically serious fluid event associated with thiazolidinedione (TZD)
- Recent ( 160mmHg or diastolic BP >90mmHg while on antihypertensive
- Hypersensitivity to TZDs, biguanides
- Prior treatment with two or more oral anti-diabetic (OAD) agents
- Bilateral hip replacements
- Concurrent diseases affecting bone metabolism
- Active malabsorption syndrome
- Serum calcium outside the central lab reference range
- Thyroid replacement therapy, serum thyroid stimulating hormone (TSH) must be within range
- Vitamin D deficiency
- Previous treatment with: strontium, intravenous (IV) bisphosphonate, fluoride, hormones, calcineurin inhibitors or methotrexate
- Chronic systemic corticosteroid [e.g. glucocorticoid, mineralocorticoid] treatment of no more than two intra-articular injections within the past year or use of oral parenteral, or long-term, high-dose inhaled corticosteroids
Data sourced from ClinicalTrials.gov (NCT00679939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.