Efficacy of Pioglitazone on Bone Metabolism in Postmenopausal Women With Impaired Fasting Glucose. (NCT00708175) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Pioglitazone on Bone Metabolism in Postmenopausal Women With Impaired Fasting Glucose.
United States156 participantsStarted 2008-05
Plain-language summary
The purpose of this study is to evaluate the effect of pioglitazone on bone metabolism in postmenopausal women with impaired fasting glucose.
Who can participate
Age range70 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Percent Change From Baseline to Month 12 in Bone Mineral Density in the Total Proximal Femur by Dual-Energy-Ray Absorptiometry (DXA)