Status:
COMPLETED
Efficacy of Pioglitazone on Bone Metabolism in Postmenopausal Women With Impaired Fasting Glucose.
Lead Sponsor:
Takeda
Conditions:
Bone Metabolism
Eligibility:
FEMALE
Up to 70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effect of pioglitazone on bone metabolism in postmenopausal women with impaired fasting glucose.
Detailed Description
The World Health Organization has estimated that 30% of all women aged over 50 years (postmenopausal) have osteoporosis according to a definition of Bone Mineral Density at any site being more than 2....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00708175
Start Date
May 1 2008
End Date
February 1 2011
Last Update
February 3 2012
Active Locations (34)
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1
Greenbrae, California, United States
2
Los Banos, California, United States
3
San Diego, California, United States
4
Walnut Creek, California, United States