Rheumatoid ArthritisNCT05443360
To Evaluate the Efficacy and Safety of Amorphous Calcium Carbonate in RA Patient With Osteopenia or Osteoporosis
A study testing DENSITY™ (Amorphous calcium carbonate, ACC) and Crystalized calcium carbonate (CCC) in people with Rheumatoid Arthritis and Osteopenia or Osteoporosis, run by China Medical University Hospital at 2 sites in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Osteopenia or Osteoporosis
- What is being tested?
- DENSITY™ (Amorphous calcium carbonate, ACC) and Crystalized calcium carbonate (CCC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesTaiwan
- Study dates
- 14 Apr 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404327
Der-Yuan Chen, Doctor, 886-4-22052121 ext. 2031, dychen1957@gmail.com
- Recruiting
Taipei Veterans General Hospital
Taipei, 112201
Wei-Sheng Chen, Doctor, 886-2-28712121 ext. 3366, weisheng0112@gmail.com
About this study
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
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).
Read the 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.
- Conditions
- Rheumatoid Arthritis, Osteopenia or Osteoporosis
- Being tested
- DENSITY™ (Amorphous calcium carbonate, ACC), Crystalized calcium carbonate (CCC)
- Medical subject headings
- Arthritis, Rheumatoid, Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DENSITY™ (Amorphous calcium carbonate, ACC)Dietary supplement
- 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.
Crystalized calcium carbonate (CCC)Dietary supplement
- 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.
| Study group | Role | What they receive |
|---|---|---|
| amorphous calcium carbonate (ACC group) | Experimental | oral use, 2 ACC tablets (1000 mg / tablet, 200 mg calcium element / tablet) twice daily given after breakfast and dinner. Receives: Dietary Supplement: DENSITY™ (Amorphous calcium carbonate, ACC) |
| crystalized calcium carbonate (CCC group) | Active comparator | oral use, 2 CCC tablets (1000 mg / tablet, 200 mg calcium element / tablet) twice daily given after breakfast and dinner. Receives: Dietary Supplement: Crystalized calcium carbonate (CCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 12 months
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.
Measured: 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)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start14 Apr 2022
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Der-Yuan Chen, China Medical University Hospital
- Investigators
- Der-Yuan Chen, Doctor, Principal investigator, Rheumatology and Immunology CenterWei-Sheng Chen, Doctor, Principal investigator, Division of Allergy, immunology and Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443360
- Sponsor's protocol ID
- CMUH111-REC2-014
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05443360
- Acronym / sponsor ID
- CMUH111-REC2-014
- Conditions
- Rheumatoid Arthritis, Osteopenia or Osteoporosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amorphous calcium carbonate (ACC group) | Experimental | Dietary Supplement: DENSITY™ (Amorphous calcium carbonate, ACC)oral 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 comparator | Dietary Supplement: Crystalized calcium carbonate (CCC)oral use, 2 CCC tablets (1000 mg / tablet, 200 mg calcium element / tablet) twice daily given after breakfast and dinner. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DENSITY™ (Amorphous calcium carbonate, ACC)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. | Dietary supplement | amorphous calcium carbonate (ACC group) |
| Crystalized calcium carbonate (CCC)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. | Dietary supplement | crystalized calcium carbonate (CCC group) |
Primary outcome
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
Time frame: 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.
4 secondary outcomes
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
Time frame: 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
Time frame: 12 months
FRAX score (Fracture Risk Assessment Tool) change from baseline at Visit 1, 4, and 6
Time frame: 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)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Der-Yuan Chen, Doctor principal investigator
Rheumatology and Immunology Center
Wei-Sheng Chen, Doctor principal investigator
Division of Allergy, immunology and Rheumatology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DENSITY™ (Amorphous calcium carbonate, ACC) and Crystalized calcium carbonate (CCC) in people with Rheumatoid Arthritis and Osteopenia or Osteoporosis, run by China Medical University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Der-Yuan Chen, Doctor (886-4-22052121 ext. 2031, dychen1957@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.