To Evaluate the Efficacy and Safety of Amorphous Calcium Carbonate in RA Patient With Osteopenia or Osteoporosis
A Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of Amorphous Calcium Carbonate in Rheumatoid Arthritis Patients With Osteopenia or Osteoporosis
1 other identifier
interventional
180
1 country
2
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable rheumatoid-arthritis
Started Apr 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 14, 2022
CompletedFirst Submitted
Initial submission to the registry
June 15, 2022
CompletedFirst Posted
Study publicly available on registry
July 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedJuly 5, 2022
June 1, 2022
1.8 years
June 15, 2022
June 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
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.
12 months
Secondary Outcomes (4)
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
Study Arms (2)
amorphous calcium carbonate (ACC group)
EXPERIMENTALoral use, 2 ACC tablets (1000 mg / tablet, 200 mg calcium element / tablet) twice daily given after breakfast and dinner.
crystalized calcium carbonate (CCC group)
ACTIVE COMPARATORoral use, 2 CCC tablets (1000 mg / tablet, 200 mg calcium element / tablet) twice daily given after breakfast and dinner.
Interventions
1. Dosage form: tablet 2. Dose(s): 1000 mg /tablet, comprising 500 mg amorphous calcium carbonate per tablet (calcium element 200mg) 3. Dosing schedule: The usual dose for oral use is 2 ACC tablets (400 mg calcium element) twice daily given after breakfast and dinner.
1. Dosage form: tablet 2. Dose(s): 1000 mg /tablet, comprising 500 mg crystalized calcium carbonate per tablet (calcium element 200mg) 3. Dosing schedule: The usual dose for oral use is 2 CCC tablets (400 mg calcium element) twice daily given after breakfast and dinner.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
China Medical University Hospital
Taichung, 404327, Taiwan
Taipei Veterans General Hospital
Taipei, 112201, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Der-Yuan Chen, Doctor
Rheumatology and Immunology Center
- PRINCIPAL INVESTIGATOR
Wei-Sheng Chen, Doctor
Division of Allergy, immunology and Rheumatology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Rheumatology and Immunology Center
Study Record Dates
First Submitted
June 15, 2022
First Posted
July 5, 2022
Study Start
April 14, 2022
Primary Completion
January 31, 2024
Study Completion
January 31, 2024
Last Updated
July 5, 2022
Record last verified: 2022-06