Effect and Cost Comparation of Different Treatment Strategies for Osteoporotic Vertebral Fractures (OVF): Teriparatide Injection and Percutaneous Vertebroplasty (PVP)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 主要终点
- Quality of life of the patients
研究概览
简要总结
This study aimed to compare teriparatide treatments and PVPs, focusing on its effects on life qualities and effect/coast ratio and evaluate which method is better for patients.
详细描述
Osteoporosis and osteoporotic vertebral fracture (OVF)s are the common diseases that affect the qualities of senior people. The general treatments for OVFs including percutaneous vertebroplasty (PVP) operation and conservative treatments with pain killers. But with the widely used methods, the life quality of patients were still not satisfied. Teriparatide has been proven to increase bone qualities in patients with severe osteoporosis and reduced the fracture possibilities. The investigators' previous clinical observation found teriparatide could be applied to treat fresh OVFs.
90 participants who diagnosed fresh OVFS were included in the trial. After they received each of three kinds of interventions mentioned in this study, The investigators followed up all these cases. Once 30 cases goal reaches in a certain group, the data collection in that special will stop automatically. The quality of life, pain score and BMDs will be evaluated in certain time during the trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 49 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1.postmenopausal women with osteoporotic fractures 2.treated with teriparatide 3.or treated with vertebroplasty 4.or treated with teriparatide after vertebroplasty 5.or treated with Fosamax
- •willing to anticipate the trial
排除标准
- •Serious other illness or disease which effecting quality of life occurs later in treatment
- •unwilling to anticipate the trial
研究组 & 干预措施
teriparatide group
The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide
干预措施: Teriparatide (Drug)
PVP group plus alendronate
The group of postmenopausal women who diagnosis with osteoporotic fractures treated with vertebroplasty. Then alendronate was prescribed.
干预措施: PVP (Procedure)
PVP group plus alendronate
The group of postmenopausal women who diagnosis with osteoporotic fractures treated with vertebroplasty. Then alendronate was prescribed.
干预措施: Alendronate (Drug)
teriparatide and PVP group
The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide after vertebroplasty
干预措施: Teriparatide (Drug)
teriparatide and PVP group
The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide after vertebroplasty
干预措施: PVP (Procedure)
结局指标
主要结局
Quality of life of the patients
时间窗: Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment
The quality of life will be evaluated with SF-36 questionaire
次要结局
- Bone healing(3 month after treatment)
- Bone mineral density(Change from pre treatment at 6 months, 1 year and 2 years post treatment)
- Pain cause by the fracture(Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment)