To Compare Efficacy of Weekly Versus Daily Teriparatide in the Management of Postmenopausal Osteoporosis
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
- 否
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
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
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
Sanjay K. Bhadada
Associate Professor, Dept of Endocrinology
Post Graduate Institute of Medical Education and Research, Chandigarh
