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临床试验/NCT01760798
NCT01760798Unknown不适用

To Compare Efficacy of Weekly Versus Daily Teriparatide in the Management of Postmenopausal Osteoporosis

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
BMD at Hip and lumber spine

研究概览

简要总结

Osteoporosis is characterized by decreased bone strength and it is prevalent among postmenopausal women but also occurs in men and women with underlying conditions or major risk factors associated with bone demineralization. Its chief clinical manifestations are vertebral and hip fractures, although fractures can occur at any skeletal site.The World Health Organization (WHO) operationally defines osteoporosis as a bone density that falls 2.5 standard deviations (SD) below the mean for young healthy adults of the same gender-also referred to as T-score of -2.5. Postmenopausal women who fall at the lower end of the young normal range (a T-score of >1 SD below the mean) are defined as having low bone density (osteopenia) and are also at increased risk of osteoporosis. More than 50% of the fractures, including hip fractures, among postmenopausal women occur in this group.

Teriparatide is one of the most effective treatment options for osteoporosis. But the cost of teriparatide is prohibitively expensive and in countries like India with limited personal resources of the individuals, its not a feasible option in the majority of the patients with severe osteoporosis. The investigators aim to compare weekly versus daily teriparatide therapy in an open label non inferiority trial and if successful, the investigators anticipate, the cost of treatment could be reduced considerably so that treatment becomes more affordable to a larger number of patients. Also with weekly therapy, number of multiple injections could be brought down.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal women of age group 50-70 having T score less than -2.5 SD or lower at lumbar spine or proximal femur.

排除标准

  • Patients with renal dysfunction (serum creatinine >1.5)
  • Primary and secondary hyperparathyroidism
  • Secondary osteoporosis
  • Unexplained elevated ALP (alkaline phosphatase)
  • History of therapeutic radiation
  • Active malignancy and patients having implant
  • Patients who have received i.v. or oral bisphosphonates in their disease course

研究组 & 干预措施

Daily Teriparatide group

Active Comparator

This group will recieve 20µg of teriparatide by subcutaneous route daily at 8 pm for 1 year

干预措施: Teriparatide (Drug)

Weekly Teriparatide group

Experimental

This group will recieve 60µg of teriparatide by subcutaneous route weekly at 8pm on Sunday for 1 year

干预措施: Teriparatide (Drug)

结局指标

主要结局

BMD at Hip and lumber spine

时间窗: 1 year

DEXA scan(BMD at hip and lumbar spine) at baseline and at the end of 1 year

Reduction in fracture risk

时间窗: 6 week, 6 month and 1 year

Reduction in fracture risk using online FRAX tool( WHO fracture risk assessment tool) at baseline and at 1year

次要结局

未报告次要终点

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sanjay K. Bhadada

Associate Professor, Dept of Endocrinology

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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