The bone effects of pioglitazone
- Conditions
- Type 2 diabetes mellitusOsteoporosisMetabolic and Endocrine - DiabetesMusculoskeletal - Osteoporosis
- Registration Number
- ACTRN12607000610437
- Lead Sponsor
- Andrew Grey
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Type 2 diabetes mellitus (T2DM), as defined by fasting blood glucose > 7mmol/L and/or serum glucose > 11mmol/L 2h after ingesting 75g oral glucose.
- impaired glucose tolerance, as defined by fasting blood glucose < 6-7 mmol/L and/or serum glucose 7.8-11mmol/L 2h after ingesting 75g oral glucose
Medical Conditions
- subjects with type 2 diabetes mellitus (T2DM) deemed to require early glitazone treatment and meeting Pharmac criteria for funded supply
- renal impairment (estimated glomerular filtration rate < 30ml/min).
- congestive heart failure, New York Heart Association Grade 2 or higher
- clinical liver disease.
- untreated thyroid dysfunction.
- concurrent major systemic illness, including malignancy.
- metabolic bone diseases, or serum alkaline phosphatase (ALP) > 2x normal limit.
- primary hyperparathyroidism.
- Bone mineral density (BMD) T score < -2.0 at total hip or spine
- previous fragility fracture (forearm, humerus, hip, vertebra)
- body weight >120kg
2.2.2Medications
- use of oral glucocorticoid drugs equivalent to an average dose of prednisone = 2.5 mg/day in the preceding 12 months
- current or past use of bisphosphonate therapy
- use of hormone replacement therapy within the last 12 months
- use of other medication known to alter bone metabolism
- current use of thiazolidinediones
Insulin use is not an exclusion criterion, but insulin dose should be stable (+/- 20%) for 3 months before enrolment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method