Efficacy of Bisphosphonate Therapy on Postmenopausal Osteoporotic Women With and Without Diabetes: a Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Bone mineral density
研究概览
简要总结
The purpose of this study is to examine whether monthly oral administration of ibandronate to postmenopausal osteoporosis patients with type 2 diabetes differs in safety and efficacy compared to patients without diabetes.
详细描述
There are two major considerations in the use of bisphosphonates in diabetic patients.
- The low rate of bone turnover in diabetic patients is at risk of side effects such as excessive inhibition of bone turnover associated with the use of bisphosphonates.
- A decrease in osteocalcin following bisphosphonate use may lead to deterioration of glucose metabolism.
The efficacy of ibandronate in T2DM is not thought to be significantly different based on previous studies, but there is few study on ibandronate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age of at least 55 years at the time of screening
- •postmenopausal woman
- •diagnosis of osteoporosis
排除标准
- •history of osteoporosis treatment
- •underlying disease (e.g., heart failure, liver disease, renal disease, or malignancy)
- •the use of drugs that affect bone metabolism (e.g., steroids, immunosuppressants, gonadotropin-releasing hormone agonists, aromatase inhibitors, thiazolidinedione drugs, anticonvulsants, and antidepressants)
- •history of adverse effects of bisphosphonate or difficulty taking the drug due to an inability to sit or the presence of upper gastrointestinal disease
研究组 & 干预措施
Non-diabetes
postmenopausal women with normal glucose tolerance
干预措施: Ibandronate Oral Tablet (Drug)
diabetes
postmenopausal women with type 2 diabetes
干预措施: Ibandronate Oral Tablet (Drug)
结局指标
主要结局
Bone mineral density
时间窗: 1 year
. Percentage change in dual-energy X-ray absorptiometry (DXA) bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck, presented as least square mean and 95% confidence interval.
次要结局
- Bone turnover markers(6 month and 12 month)