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Efficacy Study of Pioglitazone HCL on Bone Metabolism in Postmenopausal Women With Impaired Fasting Glucose.
This study is currently recruiting participants.
Verified by Takeda Global Research & Development Center, Inc., August 2008
Sponsored by: Takeda Global Research & Development Center, Inc.
Information provided by: Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00708175
  Purpose

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
Bone Metabolism
Drug: Pioglitazone HCl
Phase IV

MedlinePlus related topics: Diabetes
Drug Information available for: Pioglitazone Pioglitazone hydrochloride Dextrose
U.S. FDA Resources
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

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • Percent change from baseline to 12 months in bone mineral density in the total proximal femur by dual-energy x-ray absorptiometry (DXA). [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change from 12 months to 18 months in bone mineral density in the total proximal femur by dual-energy x-ray absorptiometry (DXA). [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

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
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.
2: Placebo Comparator Drug: Pioglitazone HCl
Pioglitazone HCl placeobo-matching tablet, orally, once daily for 52 weeks.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is female and has not experienced menses for at least 5 years.
  • The subject has a FPG ≥100 and <126 mg/dL at Screening, or a 2-hour post-oral glucose tolerance test ≥ 140 and ≤199 mg/dL at Screening.
  • The subject has a BMI ≥16 and ≤35 kg/m2 and weighs <300 pounds (approximately 136 kilograms).
  • The subject must agree to take a daily supplement of Vitamin D (a minimum of 800 IU daily) and calcium (a minimum of 1100 mg daily) during the treatment and wash-out periods.
  • The subject has clinical laboratory evaluations (including clinical chemistry [except FPG], 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.
  • The subject is in good health as determined by the physician (ie, via medical history and physical examination) at Screening.

Exclusion Criteria:

  • The subject has a fasting triglyceride level >500 mg/dL.
  • The subject has a hemoglobinopathy causing anemia or interfering with glycosylated hemoglobin (A1c) assays.
  • The subject has an alanine transaminase (ALT) level ≥2.5 times the upper limit of normal (ULN), active liver disease, or jaundice.
  • The subject has vitamin D (25-OH-D) <20 ng/mL.
  • The subject has Baseline Bone Mineral Density (BMD) defined as a T-score <-2.0 at the total hip, spine, or femoral neck based on Caucasian reference values.
  • The subject has unexplained microscopic or macroscopic hematuria confirmed by repeat testing.
  • The subject has any of the following disorders:

    • Rheumatoid arthritis.
    • Thyroid, parathyroid, pituitary, nutritional, inflammatory, gastrointestinal, autoimmune, or renal or other disease known to affect bone metabolism.
    • A personal history of kidney stones.
  • The subject has a clinical history after age 45 of wrist, hip or leg fractures.
  • The subject has more than 1 mild asymptomatic vertebral deformity or any vertebral deformity attributed to osteoporosis.
  • The subject has a known history of drug abuse (defined as illicit drug use) or a known history of alcohol abuse.
  • The subject has signs and/or symptoms of heart failure.
  • The subject is taking any of the excluded medications as listed in the Excluded Medications Section.
  • The subject is not capable of understanding and complying with protocol requirements.
  • The subject or the subject's legally acceptable representative is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
  • The subject currently is 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.
  • The subject 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.
  • The subject 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.
  • Subjects who are taking or have taken pioglitazone HCl or other TZDs within 1 year of screening or were discontinued from TZD therapy due to lack of efficacy or clinical or laboratory signs of intolerance.
  • The subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, sibling) of a study site employee, involved in the conduct of this study.
  • The subject has received or donated blood or blood products within 30 days preceding the beginning of the study or plans to donate blood during the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708175

Contacts
Contact: Lisa Schwartz, RN 877-872-3700 ext 5998 lschwartz@tgrd.com
Contact: Brigit Isaacson, MBA 877-872-3700 ext 5394 bisaacson@tgrd.com

Locations
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
Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
Study Director: Alfonso Perez, MD Takeda Global Research & Development Center, Inc.
  More Information

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

Keywords provided by Takeda Global Research & Development Center, Inc.:
Glucose Metabolism Disorder
Dysmetabolic Syndrome
Type II Diabetes
Diabetes Mellitus
Lipoatrophic
Postmenopausal

Study placed in the following topic categories:
Metabolic Diseases
Pioglitazone
Diabetes Mellitus, Type 2
Diabetes Mellitus
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009