A Randomized, Open label, Parallel group clinical study comparing the relative bioavailability, safety and efficacy of Microcore NESC® with Calcium carbonate and Calcium citrate malate in osteopenic and osteoporotic patients.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.To monitor the Bone Mineral density (BMD)- Baseline and at 12 weeks
研究概览
简要总结
Ø The subjects who fulfilled theinclusion and exclusion criteria will be enrolled in the study.
Ø 60 Participants will be randomizedinto 3 groups with 20 in each group.
Ø Arm 1 - Participants withOsteopenia and Osteoporosis will take two Tablet daily of Microcore NESC®orally for 12 weeks
Ø Arm 2 - Participants withOsteopenia and Osteoporosis will take two Tablet daily of Shellcal orally for12 weeks
Ø Arm 3 - Participants withOsteopenia and Osteoporosis will take two Tablet daily of CCM orally for 12 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 45.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients must be in the age group of
- •80 years of age.
- •Males or Females: Females must be non-pregnant / non-lactating and practicing adequate birth control measures if not menopausal.
- •Patients should be able to understand and signed the informed consent form after being explained by the investigator. They must be aware of the experimental nature of the therapy, its potential benefits, side effects, risks and benefits.
- •The patients with Osteopenia and Osteoporosis, diagnosed by BMD will be enrolled (Bone mineral density, T score is between -1 and.
- •2 is called osteopenia and T-score below- 2 indicates osteoporosis).
排除标准
- •History or presence of significant:.
- •Cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrinal, immunologic, dermatologic, neurological or psychiatric disease.
- •Alcohol dependence, alcohol abuse or drug abuse within the past one year
- •Ulceration or history of gastric and / or duodenal ulcer.
- •Patients who are allergic to Investigational products
- •HIV positive or immunocompromised individuals.
结局指标
主要结局
1.To monitor the Bone Mineral density (BMD)- Baseline and at 12 weeks
时间窗: Baseline and at 12 weeks
2.Serum Calcium test for relative absorption and bioavailability.
时间窗: Baseline and at 12 weeks
3.Serum Osteocalcin - Baseline and at 12 weeks
时间窗: Baseline and at 12 weeks
4.X-ray at baseline and 12 weeks to understand any fine fracture or cracks in the osteoporotic patient and its healing or regeneration after the course of medication
时间窗: Baseline and at 12 weeks
5.Change from baseline to 12 weeks in knee / body pain intensity measured by Pain VAS Scale (0-100mm)
时间窗: Baseline and at 12 weeks
6.Changes from baseline to 12 weeks in Quality of life-Questionnaires (Short Form Health-36).
时间窗: Baseline and at 12 weeks
次要结局
- To monitor for any adverse events(Baseline upto 12 weeks)