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To Evaluate the Efficacy and Safety of Amorphous Calcium Carbonate in RA Patient With Osteopenia or Osteoporosis

NCT05443360 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-07-05

No results posted yet for this study

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).

Conditions

Interventions

DIETARY_SUPPLEMENT

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

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.

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Der-Yuan Chen, Doctor · Rheumatology and Immunology Center

  • Wei-Sheng Chen, Doctor · Division of Allergy, immunology and Rheumatology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-14
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05443360 on ClinicalTrials.gov