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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00708175 |
This is a 1 year study to evaluate the effect of pioglitazone HCL on bone metabolism in postmenopausal women with impaired fasting glucose.
Condition | Intervention | Phase |
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Bone Metabolism |
Drug: Pioglitazone HCl |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 200 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Pioglitazone HCl
Pioglitazone HCl 30 mg tablet, orally, once daily for 4 weeks, then increased to Pioglitazone HCl 45 mg tablet, orally, once daily for 48 weeks.
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2: Placebo Comparator |
Drug: Pioglitazone HCl
Pioglitazone HCl placeobo-matching tablet, orally, once daily for 52 weeks.
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Subjects participating in this study will be randomized to receive an initial starting dose of 30 mg pioglitazone or matching pioglitazone placebo, and then after one month the dose will be titrated to either 45 mg pioglitazone or matching pioglitazone placebo, where treatment will continue for one year. After one year, subjects will continue with a 6 month wash-out period to assess the potential persistence of pioglitazone's effects on bone metabolism.
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The subject has any of the following disorders:
Contact: Lisa Schwartz, RN | 877-872-3700 ext 5998 | lschwartz@tgrd.com |
Contact: Brigit Isaacson, MBA | 877-872-3700 ext 5394 | bisaacson@tgrd.com |
United States, California | |
Recruiting | |
Walnut Creek, California, United States | |
United States, Colorado | |
Recruiting | |
Lakewood, Colorado, United States | |
United States, Florida | |
Recruiting | |
Jupiter, Florida, United States | |
United States, Georgia | |
Recruiting | |
Gainesville, Georgia, United States | |
United States, Illinois | |
Recruiting | |
Chicago, Illinois, United States | |
United States, Maryland | |
Recruiting | |
Bethesda, Maryland, United States | |
United States, Michigan | |
Recruiting | |
Detroit, Michigan, United States | |
United States, Nebraska | |
Recruiting | |
Omaha, Nebraska, United States | |
United States, New Mexico | |
Recruiting | |
Albuquerque, New Mexico, United States | |
United States, New York | |
Recruiting | |
Mineola, New York, United States | |
Recruiting | |
West Haverstraw, New York, United States | |
United States, Ohio | |
Recruiting | |
Cincinnati, Ohio, United States | |
United States, Oregon | |
Recruiting | |
Portland, Oregon, United States | |
United States, Texas | |
Recruiting | |
Denton, Texas, United States |
Study Director: | Alfonso Perez, MD | Takeda Global Research & Development Center, Inc. |
Responsible Party: | Takeda Global Research & Development Center, Inc. ( VP, Clinical Science ) |
Study ID Numbers: | AD4833_402 |
Study First Received: | June 27, 2008 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00708175 |
Health Authority: | United States: Food and Drug Administration |
Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes |
Diabetes Mellitus Lipoatrophic Postmenopausal |
Metabolic Diseases Pioglitazone Diabetes Mellitus, Type 2 |
Diabetes Mellitus Metabolic disorder Glucose Metabolism Disorders |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |