Extension of the TOP 1-study (NCT03901989): Treatment of Osteoporosis by Panaceo, Pear Control Study Assessed Effect on Bone Mineral Density and Bone Turnover of Panaceo Compared to Placebo in Osteoporotic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 主要终点
- Fractures and fallings
研究概览
简要总结
Due to the fact that bone mineral density (BMD) is a not enough sensitive parameter for assessment of the bone quality and that the changes in BMD are gradually, extension of the clinical follow up is recommended. On that way the result will be more reliable.
Therefore the protocol "TOP 2-5" is the extension of TOP 1-study with a slight change of the study design. All subjects will be treated with Panaceo. It will be a "pear control", where the patient is control to himself, or herself (each patient from "placebo group (TOP1) can be compared after further years of threatment.
Additionally, extension of the follow up will provide an assessment of the fracture risk in a more reliable manner, which is considered as the most preferably outcome in majority clinical studies of osteoporosis treatment, because it is the most important requirement for the acceptance by the regulatory agencies (FDA, EMA).
详细描述
Pear control study over 4 supplementation years. Study Population: The study population will consist of patients from a previous study (start: 100 and drop out rate) with osteoporosis defined according BMD (bone mineral density) criteria: T score -2, 5 on the femoral neck, and, or T -2, 5 on L1-L5, who has not been treated before, or in whom privies treatment did not been successful, despite a gender or age. Subjects will receive PMA-zeolite .
Demonstration of efficacy of Panaceo in the treatment of osteoporosis by increasing bone mineral density and reduction of fracture risk.
Demonstration of efficacy of Panaceo in the treatment osteoporosis despite of the gender and cause.
Demonstration of efficacy of Panaceo in the patients who was on drug treatment (bisfosfonates or SERM) more than five years without significant improvement or those who are suspected on the bone turnover over-suppression.
Tolerability Safety (adverse events, vital signs, clinical chemistry)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •100 subjects with osteoporosis Among those, as a subgroup, 20 subjects with diabetes type 2 and osteoporosis; The osteoporosis- was diagnosed by standard DXA measurement (BMD T-score: - 2.5 or below )
排除标准
- •chronic renal failure, secondary osteoporosis
结局指标
主要结局
Fractures and fallings
时间窗: for a total period of 4 years
Fracture: evaluation if yes) or no) Falling: Fracture as a consequence OR no fracture OR no fallings reported
Change of BMD (Bone mineral density)
时间窗: 0-6-12 months for a total period of 4 years
BMD measurements are used to see how well osteoporosis treatments are working
次要结局
- Change of Bone remodelling marker Osteocalcin(0-12 months for a total period of 4 years)
- Change of Bone remodelling marker Betacross laps(0-12 months for a total period of 4 years)
研究者
DALIBOR KRPAN
Prof.dr.sc. Dalibor Krpan, prim.dr.med.
Polyclinic K-center