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临床试验/NCT04719572
NCT04719572Unknown不适用

Intervention Study of Different Anti-osteoporpsis Intervention Strategies in Patients With Osteopenia and Osteoporosis

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
180
试验地点
1
主要终点
The efficacy on BDM level

研究概览

简要总结

This is a 12 months, randomized, multicenter, open-label, parallel-group study in postmenopausal women and male aged 50 years or old with osteoporosis or osteopenia in China to evaluate the efficacy and safety of different anti-osteoporpsis intervention strategies.

详细描述

This is a 12 months,randomized, multicenter, open-label, pragmatic-group study in postmenopausal women and male aged 50 years or old with osteoporosis or osteopenia in China to evaluate the efficacy and safety of different anti-osteoporpsis intervention strategies, including

  • Group1: Basic treatment group (elemental calcium 600mg/ day + vitamin D 1000IU/day)
  • Group2: Basic treatment+ anti-osteoporosis drug group (alendronate, zoledronate, tripopeptide, denosumab, activated vitamin D, menatetrenone soft capsules according to the patient's condition)
  • Group3: Basic treatment + non-drug treatment group(diet, exercise, rehabilitation therapy).

Eligibility for participation will be determined by medical history, physical examination, and laboratory results obtained during a screening visit. About 180 postmenopausal women and elderly male with osteoporosis or osteopenia will be included in this study.

All subjects will be given informed consent before starting any examination and test. The following data of all subject will be collected: liver and kidney function, HbA1c, fasting blood glucose, fasting lipid profile, serum calcium, serum phosphate, parathyroid hormone, 25-hydroxy vitamin D, bone turnover markers(BTMs) (inculding serum procollagen type I N-propeptide, serum C-terminal telopeptide of type I collagen,osteocalcin and alkaline phosphatase), thoracic and lumbar spine X-ray, bone mineral density(BMD) by dual energy X-ray.

Then they will be randomized into three groups at a 1:1 ratio. Every group will be given calcium carbonate and vitamin D. In the group 2, the medication will be decided by the doctor according to the patients' condition. Particularly, denosumab has not been approved for male adaptation, we will sign an additional informed consent.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Informed consent obtained before any trial-related activities
  • Postmenopausal women and male aged 50 years or old
  • Osteoporosis by DXA or fragility fracture history
  • Osteopenia with more than one osteoporotic risk factors

排除标准

  • Secondary osteoporosis
  • Renal insufficiency (Ccr< 35ml/min)
  • New fractures < 3 months, prior bilateral hip fractures or surgical replacement.
  • Other medication contraindications
  • Malignant tumors
  • Mobility-impaired individuals

结局指标

主要结局

The efficacy on BDM level

时间窗: 12 months

The change of BDM level after different interventions

The efficacy on BTMs level

时间窗: 3 months、6months、9months、12months

The change of BTMs level after different interventions

次要结局

  • The type and rate of drug adverse reactions(12 months)
  • Fracture rate(12 months)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chunlin Li

Professor

Chinese PLA General Hospital

研究点 (1)

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