NCT06728462Recruiting
A Study of Amorphous Calcium Carbonate in Postmenopausal Women
A Study Benchmarking FREEDOM Substudy to Evaluate the Effects of Amorphous Calcium Carbonate in Postmenopausal Women
Source: ClinicalTrials.gov · Last updated 7 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 Denosumab treatment.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 205 (estimated)
- First submitted
- 6 Dec 2024
- Start date
- 4 Mar 2025
- Primary completion date
- 14 Dec 2025
- Lead sponsor
- Universal Integrated Corp.
- Diseases
- Osteoporosis
- NCT number
- NCT06728462
What you commit to
- Study type: Interventional
- Planned participants: 205
- From 4 Mar 2025 to the primary completion date, 14 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Participation in any other investigational study within 30 days prior to receiving study medication.
Other illness
- Subjects who had conditions that influence bone metabolism (i.e., Paget's disease and osteomalacia).
- Known hypersensitivity to any component of the study drug product.
- Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety.
Lab values
- Subjects had a serum 25-hydroxyvitamin D level of less than 12 ng/ml.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 60 years to 90 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.