Actively Recruiting
A Study Benchmarking FREEDOM Substudy to Evaluate the Effects of Amorphous Calcium Carbonate in Postmenopausal Women
Led by Universal Integrated Corp. · Updated on 2025-03-07
205
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
Sponsors
U
Universal Integrated Corp.
Lead Sponsor
C
Chang Gung Memorial Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of amorphous calcium carbonate (ACC) on bone mineral density (BMD) in postmenopausal women, comparing results with those from the FREEDOM substudy. This study focuses on women aged 60 to 90 years who have a BMD T-score between -4.0 and -2.5. It aims to assess ACC's impact both with and without the addition of Denosumab treatment, an osteoporosis therapy, in an open-label setting. Participants are assigned to one of two groups: the A arm includes women who meet National Health Insurance (NHI) criteria for Denosumab and receive 5 ACC tablets daily plus a 60 mg Denosumab injection every 6 months; the B arm includes women who do not meet NHI criteria or prefer not to receive Denosumab and take 5 ACC tablets daily only. All participants with certain vitamin D levels receive daily vitamin D3 supplements. The study spans 7 clinic visits over 24 months, including screening, treatment start, and follow-up visits. During visits, researchers perform BMD assessments and blood draws at baseline and months 1, 6, 12, and 24. They monitor changes in lumbar spine BMD as the primary outcome, along with overall BMD and bone turnover markers over 2 years. Participants are expected to comply with vitamin D intake limits and complete study procedures, allowing researchers to evaluate the effects of ACC with or without Denosumab on bone health.
CONDITIONS
Brief Title
A Study of Amorphous Calcium Carbonate in Postmenopausal Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal women aged 60 to 90 years
- BMD T-score between -4.0 and -2.5 at lumbar spine or total hip
- Meet National Health Insurance reimbursement criteria for Denosumab use (A arm) or do not meet criteria or unwilling to receive Denosumab (B arm)
- Nafve to osteoporosis treatment or prior bisphosphonate use less than 3 years and not within 12 months before screening
- Minimum of 2 evaluable lumbar vertebrae (L1-L4) and 1 evaluable hip
- Willing to limit additional Vitamin D3 intake to 400 IU or 800 IU daily during the study
- Able to complete study procedures and comply with instructions
- Provide signed informed consent
You will not qualify if you...
- Conditions affecting bone metabolism such as Paget's disease or osteomalacia
- Use of other osteoporosis therapies or related medications within 6 weeks before screening
- Serum 25-hydroxyvitamin D level less than 12 ng/ml
- BMD T-score less than -4.0 at lumbar spine or total hip
- More than two moderate or any severe vertebral fractures seen on spinal x-ray at screening
- Plans to start new bisphosphonate treatment during study
- Known allergy to any study drug components
- Participation in another investigational study within 30 days before study medication
- Any condition that might affect safety or study evaluation per investigator's opinion
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants take 5 DensityTM tablets daily and, for those in the A arm, receive injections of ProliaTM (denosumab) every 6 months at the study site. Vitamin D3 supplements are given based on baseline levels.
7 clinical visits including screening, regimen start, and follow-ups at Month 1, 6, 12, 18, and 24
Duration - 24 months concurrent with treatment
Participants undergo assessments including bone mineral density (BMD) and blood draws before medication administration and at Months 1, 6, 12, and 24 to monitor treatment effects.
5 visits for assessments at baseline, Month 1, 6, 12, and 24
Trial Site Locations
Total: 1 location
1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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