Long-term Follow-up in Osteoporotic Women Treated with Local Osteo-Enhancement in Europe
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in DXA score at 24 months
研究概览
简要总结
The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP.
To qualify, subjects must have previously consented, enrolled, and been treated with the AGN1 LOEP kit in CONFIRM (AgNovos Study PST-EU-101.1).
Follow-up evaluations will be conducted at 24, 36, 48 and 60 months from the date the subject originally received the AGN1 LOEP treatment. Subjects will receive DXA and X-ray imaging at the 24- and 60-month follow-up visits. The 36- and 48-month follow-up evaluations will be conducted by phone. All timepoints will include general health and medical record review.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject had previously enrolled in CONFIRM and received AGN1 LOEP treatment.
- •Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
- •Subject is capable of giving written informed consent to participate in the study.
排除标准
- •Subject was withdrawn from CONFIRM.
- •Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate.
结局指标
主要结局
Change in DXA score at 24 months
时间窗: 24 months
Change in DXA score of treated hip from baseline pre-AGN1 LOEP to 24 months post-treatment.
次要结局
- Change in DXA score at 60 months(60 months)
- Radiologic bone formation(60 months)
- Hip fracture incidence(60 months)