Osteoporosis Trial, Recruiting NCT05688969 Sponsor: Massachusetts General Hospital Condition: Osteoporosis
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Osteoporosis Trial, Recruiting

NCT05688969
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 aged over 45 years who have gone through menopause
  • People who meet the menopause criteria in one of two ways: either more than 36 months have passed since their last natural period, or more than 36 months have passed since a hysterectomy, with a specific hormone level (FSH) confirmed by blood test if under 60 years old
  • People whose treating doctor has prescribed romosozumab and whose condition meets the FDA-approved criteria for this medication — meaning they have osteoporosis with a high risk of fracture, a history of fractures caused by osteoporosis, multiple fracture risk factors, or have not responded to or cannot tolerate other osteoporosis treatments
  • People who are not considered at increased risk from a bone marrow or bone biopsy procedure

Who may not be able to join:

  • People with serious kidney disease (stage 4 chronic kidney disease)
  • People with a higher-than-normal level of a hormone called PTH in their blood
  • People with low vitamin D levels shown on a blood test
  • People with a significant psychiatric condition that, in the opinion of the trial investigators, would prevent them from giving informed consent or completing the trial procedures
  • People with excessive alcohol use or substance use that would prevent them from giving informed consent or completing the trial procedures
  • People with a known bone disease other than osteoporosis, whether present from birth or developed later
  • People who have taken certain bone medications recently: oral bisphosphonates within the past 3 months, denosumab within the past 12 months, or intravenous bisphosphonates within the past 24 months
  • People who have used oestrogens, SERMs, calcitonin, or oral or injected corticosteroids for more than 14 days in the past 2 months
  • People who have previously received romosozumab at any time

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 28 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.

Contact this trial

Principal Investigator: Benjamin Leder, MD, Massachusetts General Hospital

Phone: 617-726-6129

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
14 June 2023
Est. completion
1 February 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Osteoblast progenitor cell numbers

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: 28 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