BridgeMD
New treatment option for Calcium
Official title A Study of Amorphous Calcium Carbonate in Postmenopausal Women
ClinicalTrials.gov ID: NCT06728462
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 90, women only
You may be able to join 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...
- Subject who are naïve to osteoporosis treatment or have received prior bisphosphonate treatment for less than 3 years and not within 12 months prior...
- 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.
You likely can't join if
- people 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...
- people had a serum 25-hydroxyvitamin D level of less than 12 ng/ml.
- people had a BMD T-score of less than -4.0 at the lumbar spine or total hip.
- people 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.
See the full eligibility criteria
- 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...
- 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.
- people 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...
- people had a serum 25-hydroxyvitamin D level of less than 12 ng/ml.
- people had a BMD T-score of less than -4.0 at the lumbar spine or total hip.
- people 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 how well it works or safety.
The study team makes the final eligibility decision.
Where it's taking place
- Kaohsiung City, Taiwan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 60 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kaohsiung City, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.