Efficacy of Pioglitazone on Bone Metabolism in Postmenopausal Women With Impaired Fasting Glucose.

Exclusion Criteria

• •Has a fasting triglyceride level greater than 500 mg/dL.
• •Has a hemoglobinopathy causing anemia or interfering with glycosylated hemoglobin assays.
• •Has an alanine transaminase level greater than or equal to 2.5 times the upper limit of normal, active liver disease or jaundice.
• •Has Vitamin D (25-OH-D) less than 20 ng/mL.
• •Has Baseline Bone Mineral Density defined as a T-score less than -2.0 at the total hip, spine, or femoral neck based on Caucasian reference values.
• •Has unexplained microscopic or macroscopic hematuria confirmed by repeat testing.
• •Has any of the following disorders:
• •* Rheumatoid Arthritis
• •* Thyroid (uncontrolled on thyroid replacement therapy), parathyroid, pituitary, nutritional, inflammatory, gastrointestinal, autoimmune, or renal or other disease known to affect bone metabolism.
• •* A personal history of kidney stones.
• •Has a clinical history after age 45 of wrist, hip, or leg fractures.
• •Has a history of more than 1 asymptomatic vertebral deformity or any vertebral deformity attributed to osteoporosis.
• •Has a known history of drug abuse (defined as illicit drug use) or a known history of alcohol abuse within 2 years of Screening.
• •Has signs and/or symptoms of heart failure.
• •Is currently participating in another investigational study or has participated in an investigational study within the past 30 days or 5 half lives of the investigational product, whichever is longer.
• •Has any other serious disease or condition at screening or at randomization that might make it difficult to successfully manage and follow up with the subject according to the protocol.
• •Has a history of cancer, other than basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin that has not been in remission for at least 5 years prior to the first dose of study drug.
• •Has a history of breast cancer.
• •Is taking or has ever taken pioglitazone or other Thiazolidinediones.
• •Has received or donated blood or blood products within 30 days preceding the Screening visit or plans to donate blood during the study.