Intervention Study of Different Anti-osteoporpsis Intervention Strategies in Patients With Osteopenia and Osteoporosis
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
- 否
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
Chunlin Li
Professor
Chinese PLA General Hospital
