Osteoporosis Trial, Recruiting NCT06728462 Sponsor: Universal Integrated Corp. Condition: Osteoporosis
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Osteoporosis Trial, Recruiting

NCT06728462
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Women who have gone through menopause and are between 60 and 90 years old
  • People whose bone density scan results show bones that are weak enough to be considered osteoporosis (a T-score below -2.5 at the spine or hip), but not lower than -4.0 at either site
  • People who either meet the government health insurance (NHI) criteria for a specific bone-strengthening medication (denosumab), or who do not meet those criteria or do not wish to receive that medication during the study (two separate groups in the trial)
  • People who have never been treated for osteoporosis before, or who took a type of bone medication called bisphosphonates for less than 3 years and not within the last 12 months
  • People who have at least 2 assessable vertebrae in the lower spine and at least one assessable hip that can be measured by bone density scanning
  • People who are willing to limit extra Vitamin D3 supplements to no more than 400 or 800 IU per day during the study
  • People who are able to follow all study instructions and complete all required visits and procedures
  • People who are willing to sign a written consent form agreeing to participate

Who may not be able to join:

  • People who have conditions that affect bone health, such as Paget's disease or osteomalacia (soft bones)
  • People who have taken certain bone or hormone-related medications within the 6 weeks before the screening visit, including parathyroid hormone treatments, corticosteroids (steroids), hormone replacement therapy, certain estrogen-related drugs, calcitonin, or calcitriol
  • People whose blood test shows a Vitamin D level below 12 ng/ml
  • People whose bone density T-score is lower than -4.0 at the spine or hip
  • People who have a severe spinal fracture, or more than two moderate spinal fractures, found on an X-ray at the time of screening
  • People who plan to start a new bisphosphonate (a type of bone medication) during the study
  • People who have a known allergy or sensitivity to any ingredient in the study medication
  • People who have taken part in another clinical trial within the 30 days before starting study medication
  • People whose overall health, in the treating doctor's judgement, could affect the safety or accuracy of the trial results

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Universal Integrated Corp.
Registry
ClinicalTrials.gov
Start date
4 March 2025
Est. completion
14 December 2025

Where this trial is recruiting

🇹🇼 Taiwan

Primary endpoints

Percentage change in LBMD

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov