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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the effect of pioglitazone on bone metabolism in postmenopausal women with impaired fasting glucose.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• Is female and has not experienced menses for at least 5 years.

• Has a Fasting Plasma Glucose level greater than or equal to 100 and less than 126 mg/dL or a 2-hour post-oral glucose tolerance test greater than or equal to 140 and less than or equal to 199 mg/dL at Screening.

• Has a body mass index greater than or equal to 16 and less than or equal to 40 kg/m2 and weighs less than 300 pounds (approximately 136 kilograms).

• Agrees to take daily supplements of Vitamin D (a minimum of 800 IU daily) and calcium (a minimum of 1000 mg daily) during the treatment and wash-out periods.

• Has clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis [fasted for at least 8 hours]) within the reference range for the testing laboratory unless the results are deemed not clinically significant by the investigator or sponsor.

• Is in good health as determined by the physician (ie, via medical history and physical examination) at Screening.

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.