Efficacy of Pioglitazone on Bone Metabolism in Postmenopausal Women With Impaired Fasting Glucose.
Condition: Bone Metabolism
Intervention: Pioglitazone; Placebo
Intervention description: Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.; Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
Intervention MeSH terms: Pioglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 156.0
Sex: Female
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus; Lipoatrophic; Postmenopausal

Summary:

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

Eligibility 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.