Back to resultsTo Evaluate the Efficacy and Safety of Amorphous Calcium Carbonate in RA Patient With Osteopenia or Osteoporosis
Primary Purpose
Rheumatoid Arthritis, Osteopenia or Osteoporosis
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
DENSITY™ (Amorphous calcium carbonate, ACC)
Crystalized calcium carbonate (CCC)
Sponsored by
About this trial
This is an interventional supportive care trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- China Medical University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
amorphous calcium carbonate (ACC group)
crystalized calcium carbonate (CCC group)
Arm Description
oral use, 2 ACC tablets (1000 mg / tablet, 200 mg calcium element / tablet) twice daily given after breakfast and dinner.
oral use, 2 CCC tablets (1000 mg / tablet, 200 mg calcium element / tablet) twice daily given after breakfast and dinner.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
The percentage change from baseline in BMD measured by DXA in lumbar spine and total hip at Month 13 will be summarized with descriptive statistics and the 95% CI by study groups. The difference in percentage change from baseline in BMD between study groups will be analyzed by two sample t test.
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
The responder is defined as 20% reduction in DXA score from the baseline. The responder will be presented as count and percentage in frequency table, and the 95% exact (Clopper-Pearson) CI will be provided as well by study group. Fisher's exact test will be used for the comparison between study groups.
FRAX score (Fracture Risk Assessment Tool) change from baseline at Visit 1, 4, and 6
The FRAX score and the corresponding change from baseline at Visit 1, 4, and 6 will be summarized with descriptive statistics and the 95% CI by study groups. The difference in mean change from baseline in FRAX score between study groups will be analyzed by two sample t test. Additionally, the intra-group difference will be analyzed by paired t test.
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)
The bone turnover markers (BTM) includes P1NP (total procollagen type 1 N-terminal propeptide) and CTX (C-terminal telopeptide of type 1 collagen). For the bone turnover markers (BTM), the descriptive summary of original values and the change from baseline will be provided by study groups. Two sample t test will be used for the comparison of study groups in change from baseline be. Additionally, the intra-group comparison will be analyzed by paired t test.
Full Information
NCT ID
NCT05443360
First Posted
June 15, 2022
Last Updated
June 29, 2022
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05443360
Brief Title
To Evaluate the Efficacy and Safety of Amorphous Calcium Carbonate in RA Patient With Osteopenia or Osteoporosis
Official Title
A Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of Amorphous Calcium Carbonate in Rheumatoid Arthritis Patients With Osteopenia or Osteoporosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Osteopenia or Osteoporosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
amorphous calcium carbonate (ACC group)
Arm Type
Experimental
Arm Description
oral use, 2 ACC tablets (1000 mg / tablet, 200 mg calcium element / tablet) twice daily given after breakfast and dinner.
Arm Title
crystalized calcium carbonate (CCC group)
Arm Type
Active Comparator
Arm Description
oral use, 2 CCC tablets (1000 mg / tablet, 200 mg calcium element / tablet) twice daily given after breakfast and dinner.
Intervention Type
Dietary Supplement
Intervention Name(s)
DENSITY™ (Amorphous calcium carbonate, ACC)
Intervention Description
Dosage form: tablet
Dose(s): 1000 mg /tablet, comprising 500 mg amorphous calcium carbonate per tablet (calcium element 200mg)
Dosing schedule: The usual dose for oral use is 2 ACC tablets (400 mg calcium element) twice daily given after breakfast and dinner.
Intervention Type
Dietary Supplement
Intervention Name(s)
Crystalized calcium carbonate (CCC)
Intervention Description
Dosage form: tablet
Dose(s): 1000 mg /tablet, comprising 500 mg crystalized calcium carbonate per tablet (calcium element 200mg)
Dosing schedule: The usual dose for oral use is 2 CCC tablets (400 mg calcium element) twice daily given after breakfast and dinner.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
Description
The percentage change from baseline in BMD measured by DXA in lumbar spine and total hip at Month 13 will be summarized with descriptive statistics and the 95% CI by study groups. The difference in percentage change from baseline in BMD between study groups will be analyzed by two sample t test.
Time Frame
12 months
Title
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
Description
The responder is defined as 20% reduction in DXA score from the baseline. The responder will be presented as count and percentage in frequency table, and the 95% exact (Clopper-Pearson) CI will be provided as well by study group. Fisher's exact test will be used for the comparison between study groups.
Time Frame
12 months
Title
FRAX score (Fracture Risk Assessment Tool) change from baseline at Visit 1, 4, and 6
Description
The FRAX score and the corresponding change from baseline at Visit 1, 4, and 6 will be summarized with descriptive statistics and the 95% CI by study groups. The difference in mean change from baseline in FRAX score between study groups will be analyzed by two sample t test. Additionally, the intra-group difference will be analyzed by paired t test.
Time Frame
12 months
Title
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)
Description
The bone turnover markers (BTM) includes P1NP (total procollagen type 1 N-terminal propeptide) and CTX (C-terminal telopeptide of type 1 collagen). For the bone turnover markers (BTM), the descriptive summary of original values and the change from baseline will be provided by study groups. Two sample t test will be used for the comparison of study groups in change from baseline be. Additionally, the intra-group comparison will be analyzed by paired t test.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Der-Yuan Chen, Doctor
Phone
886-4-22052121
Ext
2031
Email
dychen1957@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Der-Yuan Chen, Doctor
Organizational Affiliation
Rheumatology and Immunology Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei-Sheng Chen, Doctor
Organizational Affiliation
Division of Allergy, immunology and Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404327
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Der-Yuan Chen, Doctor
Phone
886-4-22052121
Ext
2031
Email
dychen1957@gmail.com
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112201
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Sheng Chen, Doctor
Phone
886-2-28712121
Ext
3366
Email
weisheng0112@gmail.com
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Efficacy and Safety of Amorphous Calcium Carbonate in RA Patient With Osteopenia or Osteoporosis
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