Bone Metabolism Clinical Trial
Official title:
A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Pioglitazone Compared to Placebo on Bone Metabolism in Impaired Fasting Glucose, Postmenopausal Women for One Year of Treatment
Verified date | January 2012 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the effect of pioglitazone on bone metabolism in postmenopausal women with impaired fasting glucose.
Status | Completed |
Enrollment | 156 |
Est. completion date | February 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Takeda |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change From Baseline to Month 12 in Bone Mineral Density in the Total Proximal Femur by Dual-Energy-Ray Absorptiometry (DXA) | The change in bone mineral density in the total proximal femur at month 12 relative to baseline. DXA is a means of measuring BMD through x-ray. | Baseline and Month 12. | No |
Secondary | Percent Change From Month 12 to Month 18 in Bone Mineral Density in the Total Proximal Femur by DXA | The change in bone mineral density in the total proximal femur at month 18 relative to month 12. DXA is a means of measuring BMD through x-ray. | Month 12 and Month 18. | No |
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