What is amorphous calcium carbonate studying for osteoporosis in postmenopausal women?

Amorphous calcium carbonate is being studied to understand its effects on bone mineral density in postmenopausal women, with or without Denosumab treatment. Researchers aim to evaluate how this supplement influences bone health compared to previous studies. The trial is sponsored by Universal Integrated Corp. and helps explore treatment options for women with low bone density.

Who may be eligible for this osteoporosis clinical trial?

Women aged 60 to 90 years with low bone mineral density and a diagnosis of osteoporosis may be eligible. Participants must be postmenopausal and willing to limit vitamin D intake during the study. Those who meet National Health Insurance criteria for Denosumab may receive it as part of the trial. Please review eligibility criteria for more details.

Is there any cost to participate in this osteoporosis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should consider their own travel plans when joining this trial.

Actively Recruiting

Phase Not Applicable

Age: 60Years - 90Years

FEMALE

ID06728462

Evaluating Amorphous Calcium Carbonate Effects on Bone Density in Postmenopausal Women Comparison Using FREEDOM Substudy Benchmark

Led by Universal Integrated Corp. · Updated on 2025-03-07

205

Participants Needed

Research Sites

63 weeks

Total Duration

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 ACCs 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

Age: 60Years - 90Years

FEMALE

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

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