Status:
RECRUITING
A Study of Amorphous Calcium Carbonate in Postmenopausal Women
Lead Sponsor:
Universal Integrated Corp.
Collaborating Sponsors:
Chang Gung Memorial Hospital
Conditions:
Calcium
Osteoporosis
Eligibility:
FEMALE
60-90 years
Phase:
NA
Brief Summary
Using the FREEDOM substudy as a benchmark, evaluate the effects of amorphous calcium carbonate (ACC) on bone mineral density (BMD) in postmenopausal women, both with and without the combination of Den...
Detailed Description
This is an open-label study to evaluate the effect of DensityTM, amorphous calcium carbonate (ACC), in postmenopausal women, compared to FREEDOM substudy. Subjects with a BMD T-score between -4.0 to ...
Eligibility Criteria
Inclusion Criteria:
-
Postmenopausal women who are 60 to 90 years of age.
-
With BMD T-score of lower than -2.5 at the lumbar spine or total hip and -4.0 or higher at both sites. Subject who also meet the following criteria:
A arm:-Subject who meet National Health Insurance (NHI) reimbursement criteria for use of denosumab.
B arm:-Subject who does not meet NHI reimbursement criteria for use of denosumab, or who is no willing to receive denosumab treatment during study period, even meet NHI reimbursement criteria.
-
Subject who are naïve to osteoporosis treatment or have received prior bisphosphonate treatment for less than 3 years and not within 12 months prior to screening visit.
-
A minimum of 2 evaluable lumbar vertebrae in the L1-L4 region and 1 evaluable hip (i.e., either the left or right side).
-
Willingness to limit additional Vitamin D3 intake to 400IU or 800IU 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 consent.
Exclusion Criteria:
- Subjects who had conditions that influence bone metabolism (i.e., Paget's disease and osteomalacia).
- Subject on other osteoporosis therapies, parathyroid hormone or its derivatives, corticosteroids, systemic hormone-replacement therapy, selective estrogen-receptor modulators, tibolone, calcitonin or calcitriol 6 weeks prior to screening visit.
- Subjects had a serum 25-hydroxyvitamin D level of less than 12 ng/ml.
- Subjects had a BMD T-score of less than -4.0 at the lumbar spine or total hip.
- Subjects with any severe or more than two moderate vertebral fractures on spinal x-ray at screening visit.
- Subject who plan to initiate a new bisphosphonate treatment during study period.
- Known hypersensitivity to any component of the study drug product.
- 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.
Key Trial Info
Start Date :
March 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT06728462
Start Date
March 4 2025
End Date
March 1 2027
Last Update
March 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan