ACTRN12607000610437已完成4 期
A randomized controlled trial of the effects of pioglitazone on bone density and bone turnover in type 2 diabetes mellitus
Andrew Grey0 个研究点目标入组 100 人开始时间: 2007年11月28日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 30 Years 至 o limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
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