A Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of Amorphous Calcium Carbonate in Rheumatoid Arthritis Patients With Osteopenia or Osteoporosis
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Mean change from baseline in bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA) in lumbar spine and total hip at Month 13
研究概览
简要总结
DensityTM, an amorphous calcium carbonate (ACC) imported by Universal Integrated Corporation, is tried to demonstrate its efficacy and safety in rheumatoid arthritis patient with osteopenia or osteoporosis, compared to crystalized calcium carbonate (CCC).
详细描述
This is a randomized, double-blind, active-controlled study to evaluate the efficacy and safety of amorphous calcium carbonate in rheumatoid arthritis patients with osteopenia or osteoporosis, compared to crystalized calcium carbonate.
A total of 180 subjects will be enrolled into this study. Eligible subjects will be randomized to receive amorphous calcium carbonate (ACC group) or crystalized calcium carbonate (CCC group) with 1:1 allocation. Randomization will be stratified by the use of biologics. The study product, 2 tablets (400mg calcium element), will be taken twice daily approximately 30 minutes after breakfast and dinner during 12-month treatment period. Additional 600 IU vitamin D3 will be also received with investigational product after breakfast.
The study will consist of 7 clinical visits. Subjects will come to the clinics at Visit 1 (screening visit), Visit 2 (randomization, regimen start), Visit 3 to 6 (follow-up visits), and Visit 7 (post-treatment follow-up visits) according to the pre-defined schedule.
The DXA score, and BTM (P1NP, CTX) from fasting serum samples, and FRAX score will be collected. The treatment-emergent adverse events for safety endpoints will be also recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ≧45 years of age.
- •Diagnosis of rheumatoid arthritis according to 2010 American College of Rheumatology Guideline (ACR Guideline), with severe osteopenia or osteoporosis.
- •With a DAS28 (Disease Activity Score 28) score ranged from 2.6 to 5.1 at screening visit.
- •With a documented DXA score ≦-2.0 at the lumbar spine or total hip and without compression fracture within the 3 months prior to screening visit.
- •With a FRAX score at least medium risk (major osteoporotic fracture 10-19%, hip fracture 1-3%) at screening visit.
- •Willingness to limit additional vitamin D3 intake to 600 IU per day during the study period.
- •Ability to complete the entire procedure and to comply with study instructions.
- •Will provide completed and signed written informed consents.
排除标准
- •History of or current diseases that may interfere serum calcium, such as hypocalcemia, hypercalcemia, hyperparathyroidism, hypoparathyroidism, hyperthyroidism or hypothyroidism, or other metabolic bone disease, from any cause within 1 year prior to screening.
- •Chronic kidney disease with receiving peritoneal dialysis or hemodialysis
- •Known hypersensitivity to any component of the study product.
- •Current treatment with any anti-osteoporotic drug (i.e. bisphosphonates, Denosumab (Prolia), teriparatide (Forteo), Romosozumab (Evenity), Raloxifene (Evista), etc.).
- •Any previous or ongoing clinically significant illness that may interfere with the study conduct, as judged by the investigator.
- •Participation in any other investigational study within 30 days prior to receiving study medication.
- •Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety.
结局指标
主要结局
Mean change from baseline in bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA) in lumbar spine and total hip at Month 13
时间窗: 12 months
The BMD and the corresponding change from baseline will be summarized with descriptive statistics and the 95% CI by study groups. The difference in mean change from baseline in BMD between study groups will be analyzed by two sample t test. Additionally, the intra-group difference will be analyzed by paired t test.
次要结局
- Percentage change from baseline in bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA) in lumbar spine and total hip at Month 13(12 months)
- Responder number and rate in bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA) in lumbar spine and total hip at Month 13(12 months)
- FRAX score (Fracture Risk Assessment Tool) change from baseline at Visit 1, 4, and 6(12 months)
- Bone turnover markers (BTM) change from baseline level 5.1 P1NP (total procollagen type 1 N-terminal propeptide) 5.2 CTX (C-terminal telopeptide of type 1 collagen)(12 months)
研究者
Der-Yuan Chen
Rheumatology and Immunology Center
China Medical University Hospital