Tests a calcium supplement's effect on bone density in older women
Tests amorphous calcium carbonate in postmenopausal women with bone thinning, with or without denosumab.
Plain-language title generated from the registry record
Registry title: A Study of Amorphous Calcium Carbonate in Postmenopausal Women
Key facts
- Where
- Kaohsiung City, TaiwanSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 90 years old?
Source: NCT06728462, who can take part
Where in Taiwan
- Kaohsiung Chang Gung Memorial HospitalKaohsiung City, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universal Integrated Corp.
- Trial code
- NCT06728462
- Record updated
- 7 March 2025
- Original description
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.Read full original descriptionShow less
A Study Benchmarking FREEDOM Substudy to Evaluate the Effects of Amorphous Calcium Carbonate in Postmenopausal Women
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.
Inclusion: 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: 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; 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; 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.