Evaluating Amorphous Calcium Carbonate in Postmenopausal Women
A Study Benchmarking FREEDOM Substudy to Evaluate the Effects of Amorphous Calcium Carbonate in Postmenopausal Women
This study is testing if a new form of calcium can help improve bone health in postmenopausal women, both on its own and when combined with another medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 205 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | Female |
| Sponsor | Universal Integrated Corp. Industry-sponsored |
| Drugs / interventions | denosumab |
| Locations | 1 site (Kaohsiung City) |
| Trial ID | NCT06728462 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of amorphous calcium carbonate (ACC) on bone mineral density (BMD) in postmenopausal women, comparing those receiving ACC alone to those receiving ACC in combination with Denosumab. Participants will be assigned to one of two arms based on their eligibility for Denosumab treatment. The study will involve a total of 205 subjects, with clinical visits scheduled throughout the study period to monitor BMD changes and overall health. The primary goal is to assess the effectiveness of ACC in improving bone health in this population.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 60 to 90 with specific bone mineral density criteria.
Not a fit: Patients who do not meet the eligibility criteria for osteoporosis treatment or have had recent bisphosphonate treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to improve bone mineral density in postmenopausal women at risk for osteoporosis.
How similar studies have performed: Other studies have shown success with similar approaches in improving bone density, but this specific combination of treatments is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Postmenopausal women who are 60 to 90 years of age. 2. 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. 3. 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. 4. A minimum of 2 evaluable lumbar vertebrae in the L1-L4 region and 1 evaluable hip (i.e., either the left or right side). 5. Willingness to limit additional Vitamin D3 intake to 400IU or 800IU per day during the study period. 6. Ability to complete the entire procedure and to comply with study instructions. 7. Will provide completed and signed written informed consent. Exclusion Criteria: 1. Subjects who had conditions that influence bone metabolism (i.e., Paget's disease and osteomalacia). 2. 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. 3. Subjects had a serum 25-hydroxyvitamin D level of less than 12 ng/ml. 4. Subjects had a BMD T-score of less than -4.0 at the lumbar spine or total hip. 5. Subjects with any severe or more than two moderate vertebral fractures on spinal x-ray at screening visit. 6. Subject who plan to initiate a new bisphosphonate treatment during study period. 7. Known hypersensitivity to any component of the study drug product. 8. Participation in any other investigational study within 30 days prior to receiving study medication. 9. Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety.
Where this trial is running
Kaohsiung City
- Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.