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Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health
This study is currently recruiting participants.
Verified by GlaxoSmithKline, September 2008
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00679939
  Purpose

The purpose of this study is to determine the effects of rosiglitazone on the bone in postmenopausal women with type 2 diabetes mellitus


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Rosiglitazone
Phase IV

MedlinePlus related topics: Diabetes Minerals
Drug Information available for: Rosiglitazone Rosiglitazone Maleate X-Rays
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Pharmacodynamics Study
Official Title: A 52 Week Randomized, Double-Blind, Multicenter, Mechanistic Study With a 24 Week Open-Label Follow-Up to Evaluate the Effect of AVANDIA TM on Bone in Postmenopausal Women With Type 2 Diabetes Mellitus

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Bone mineral density of the hip from baseline to 52 weeks.

Secondary Outcome Measures:
  • BMD of hip & spine: baseline to mths 4, 7, 12 & 18. Measures of bone formation & resorption: baseline to mths 3, 7, 12, 16 & 18. Measures of sex hormones & calcium homeostasis: baseline to mths 12 & 18. Measures of clinical safety over time.

Estimated Enrollment: 226
Study Start Date: April 2008
  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female, >55 to <80 years
  • >5 years menopausal
  • T2DM diagnosis according to ADA, AACE, CDA, WHO/IDF
  • Drug-naïve (HbA1c < or = 9.0%); OR Prior monotherapy, submaximal doses of metformin (< or = 1000mg MET), sulfonylureas (< or = 5mg Glyburide, < or = 10mg Glipizide or < or = 8mg glimepiride) or full dose Januvia (100mg) (HbA1c < or = 8.5%); OR Prior monotherapy, > submaximal doses of metformin (>1000mg) or sulfonylureas (>5mg Glyburide, >10mg Glipizide or >8mg glimepiride) (HbA1c < or = 7.0%)
  • Weighs <300 lbs (136.4 kg)
  • Two or more vertebra (L1-L4) suitable for BMD measurement by DXA
  • Absolute BMD value consistent with T-score >-2.5 at femoral neck, lumbar spine and total hip

Exclusion Criteria:

  • T1DM or history of DKA
  • Renal or hepatic disease (clin. sig.)
  • Hepatocellular rxn, severe edema, or med. serious fluid event associated with TZD
  • Recent (<6mos) history or clinical intervention for angina or myocardial infarction or is taking nitrates
  • Any stage of heart failure, i.e. NYHA class I-IV
  • Systolic BP >160mmHg or diastolic BP >90mmHg while on antihypertensive
  • Hypersensitivity to TZDs, biguanides
  • Prior tx with two or more OAD agents
  • Bilateral hip replacements
  • Concurrent diseases affecting bone metabolism
  • Active malabsorption syndrome
  • Serum calcium outside the central lab ref range
  • Thyroid replacement therapy, serum TSH must be within range
  • Vitamin D deficiency
  • Previous tx with: strontium, IV bisphosphonate, fluoride, hormones, calcineurin inhibitors or methotrexate
  • Chronic systemic corticosteroid [e.g. glucocorticoid, mineralocorticoid] treatment of no more than two intra-articular injections within the past year or use of oral parenteral, or long-term, high-dose inhaled corticosteroids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679939

  Show 47 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials Call Centre, MD, MPH GlaxoSmithKline
  More Information

Study ID Numbers: AVD111179
Study First Received: May 15, 2008
Last Updated: September 12, 2008
ClinicalTrials.gov Identifier: NCT00679939  
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by GlaxoSmithKline:
Type 2 diabetes mellitus
bone
bone mineral density
bone biomarkers
dual-energy
x-ray absorptiometry

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Rosiglitazone

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

ClinicalTrials.gov processed this record on January 15, 2009