Clinical TrialID 7328
To Evaluate the Efficacy and Safety of Amorphous Calcium Carbonate in RA Patient With Osteopenia or Osteoporosis
NCT05443360
Rheumatoid Arthritis|Osteopenia or Osteoporosis
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7328
- Evidence Id
- 7328
- Core Evidence Id
- 7328
- Source Clinical Trial Id
- 7319
- Herb2 Clinical Trial Id
- HBCT007319
- Nct Id
- NCT05443360
- Title
- To Evaluate the Efficacy and Safety of Amorphous Calcium Carbonate in RA Patient With Osteopenia or Osteoporosis
- Status
- Phase
- Study Result
- No
- Study Condition
- Rheumatoid Arthritis|Osteopenia or Osteoporosis
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
- Intervention
- DIETARY_SUPPLEMENT: DENSITY™ (Amorphous calcium carbonate, ACC)|DIETARY_SUPPLEMENT: Crystalized calcium carbonate (CCC)
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Double
- Intervention Purpose
- Supportive_Care
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 180
- 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, 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
- Sponsor Collaborator
- China Medical University Hospital
- Funded By
- OTHER
- Location
- China Medical University Hospital, Taichung, 404327, Taiwan|Taipei Veterans General Hospital, Taipei, 112201, Taiwan
- Other Id
- CMUH111-REC2-014
- Start Date
- 2022-04-14
- Primary Completion Date
- 2024-01-31
- Completion Date
- 2024-01-31
- First Posted
- 2022-07-05
- Results First Posted
- Last Update Posted
- 2022-07-05
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05443360
- Title Cn
- Title En
- To Evaluate the Efficacy and Safety of Amorphous Calcium Carbonate in RA Patient With Osteopenia or Osteoporosis
- Bilingual Status
- semi_complete