Actively Recruiting

Phase Not Applicable
Age: 60Years - 90Years
FEMALE
NCT06728462

A Study of Amorphous Calcium Carbonate in Postmenopausal Women

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

205

Participants Needed

1

Research Sites

103 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

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.

CONDITIONS

Official Title

A Study of Amorphous Calcium Carbonate in Postmenopausal Women

Who Can Participate

Age: 60Years - 90Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenopausal women aged 60 to 90 years
  • BMD T-score between -4.0 and -2.5 at the lumbar spine or total hip
  • Meet National Health Insurance reimbursement criteria for denosumab use (A arm) or do not meet criteria or decline denosumab treatment (B arm)
  • Nafve to osteoporosis treatment or prior bisphosphonate treatment less than 3 years and not within 12 months prior to screening
  • At least 2 evaluable lumbar vertebrae in L1-L4 and 1 evaluable hip
  • Willingness to limit additional Vitamin D3 intake to 400 IU or 800 IU daily during the study
  • Ability to complete study procedures and comply with instructions
  • Provide signed informed consent
Not Eligible

You will not qualify if you...

  • Conditions affecting bone metabolism such as Paget's disease or osteomalacia
  • Use of osteoporosis therapies, parathyroid hormone or derivatives, corticosteroids, systemic hormone replacement therapy, selective estrogen-receptor modulators, tibolone, calcitonin or calcitriol within 6 weeks prior to screening
  • Serum 25-hydroxyvitamin D level below 12 ng/ml
  • BMD T-score less than -4.0 at the lumbar spine or total hip
  • Severe or more than two moderate vertebral fractures on spinal x-ray at screening
  • Plans to start new bisphosphonate treatment during the study
  • Known allergy to any component of the study drug
  • Participation in other investigational studies within 30 days before study medication
  • Any condition that may jeopardize safety or efficacy evaluation according to the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Actively Recruiting

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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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