Study and Follow-up of the Clinical Effectiveness and Comparative Safety of Biosimilar Teriparatide in the Management of Postmenopausal or Senile (ESECTO)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 188
- 试验地点
- 10
- 主要终点
- Effectiveness for patients treatment with original
研究概览
简要总结
Non-interventional observational prospective follow-up study of cohorts of patients with Previous diagnosis of Osteoporosis with high risk of fractures, with/without previous fractures and treatment with bone formers (biosimilar or original Teriparatide), who meet all the inclusion criteria and exclusion, with prior information and signing of prior informed consent documents.
详细描述
Non-interventional observational prospective follow-up study of cohorts of patients with Previous diagnosis of Osteoporosis with high risk of fractures, with/without previous fractures and treatment with bone formers (biosimilar or original Teriparatide), who meet all the inclusion criteria and exclusion, with prior information and signing of prior informed consent documents.
Primary objective:
Verify the clinical effectiveness of Teriparatide Biosimilar under clinical practice conditions real. Compare this clinical effectiveness with original Teriparatide administered under similar conditions of actual clinical practice. Design: Observational cohort study, prospective, multicenter, nationwide. Study population: Patients with a previous diagnosis of Osteoporosis with a high risk of fractures,with/without previous fractures and in treatment with bone formers since before the start of the study. The patients will be distributed into 2 cohorts based on whether they are receiving similar Teriparatide (cohort A) or original Teriparatide (Cohort B).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing the Informed Consent Men or women of legal age who have completed somatic growth.
- •Previous diagnosis of densitometric osteoporosis in any location (densitometry with DEXA diagnosis within 6 months prior to start of treatment) or previous diagnosis of established osteoporosis (due to previous low-impact fracture, central or peripheral)
- •Being in previous treatment with similar Teriparatide (cohort A) or with original Teriparatide (Cohort B).
- •Be in possession of mental faculties to understand the therapeutic proposal, understand and follow the follow-up protocol and be able to sign the consent document informed.
排除标准
- •The informed consent signature was not obtained.
- •Patients who meet any of the contraindications for the use of teriparatide.
结局指标
主要结局
Effectiveness for patients treatment with original
时间窗: 24 Months
At the different moments of analysis (6, 12 and 24 months of treatment) in each of the treatment groups will be presented. The 95% confidence interval will be calculated for the mean percent change difference between groups. Likewise, the Student's t-test will be calculated for independent samples to assess statistical significance. To determine the fracture rate of any location during the study, the percentage of patients in each of the groups will be calculated descriptively. This proportion of patients will be compared between groups using Pearson's Chi-square test or Fisher's exact test, when applicable. The baseline-final change in biochemical markers of bone remodeling (BRM) between treatment groups will also be evaluated through the Student's t-test for independent samples if they meet the normality parameters or, failing that, its corresponding non-parametric test. (Mann-Whitney U test). .
次要结局
- Falls(24 Months)
- TBS(24 Months)
- Previous bone fractures(30 Months)
- Security profile(30 Months)
- Confirm fracture rate in any localization while study is ongoing(30 Months)
- Risk factor of osteoporosis(30 Months)
- Anthropometric clinical data(24 Months)
- Hepatic profile(24 Months)
- Bone remodelling biomarkers(24 Months)
- FRAX(24 Months)
- Bone fractures during treatment(24 Months)
- Demographic and personal aspects related to the risk of osteoporosis(24 Months)
- Previous clinical data(24 Months)
- Osteoporosis diagnosis(24 Months)
- Previous treatment for osteoporosis(24 Months)
- Complementary previous treatment for osteoporosis(24 Months)