NCT06728462

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Mar 2025Mar 2027

First Submitted

Initial submission to the registry

December 6, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

March 4, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

March 7, 2025

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

December 6, 2024

Last Update Submit

March 4, 2025

Conditions

CalciumOsteoporosisBone Mineral DensityBone Turnover MarkerDenosumab

Outcome Measures

Primary Outcomes (1)

  • Percentage change in LBMD

    Percent change from baseline of bone mineral density (BMD) at the lumbar spine (L1, L2, L3, L4)

    2 years

Secondary Outcomes (2)

  • Percentage change in BMD

    2 years

  • Success rate in bone turnover markers (BTMs)

    2 years

Study Arms (2)

A arm

OTHER

Subject who meet National Health Insurance (NHI) reimbursement criteria for use of denosumab

Dietary Supplement: Amorphous calcium carbonate

B arm

OTHER

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

Dietary Supplement: Amorphous calcium carbonate

Interventions

Amorphous calcium carbonateDIETARY_SUPPLEMENT

The usual dose for oral use is 5 ACC tablets (equal to 1000 mg calcium element) daily given after meals.

A armB arm

Eligibility Criteria

Age60 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmenopausal Women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects who had conditions that influence bone metabolism (i.e., Paget's disease and osteomalacia).
  • 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.
  • 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.
  • Known hypersensitivity to any component of the study drug product.
  • Participation in any other investigational study within 30 days prior to receiving study medication.
  • Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: External comparator arm study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2024

First Posted

December 11, 2024

Study Start

March 4, 2025

Primary Completion

December 14, 2025

Study Completion (Estimated)

March 1, 2027

Last Updated

March 7, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)