Osteoporosis Trial, Recruiting NCT07027306 Sponsor: AO Foundation, AO Spine Condition: Osteoporosis
Back to Osteoporosis

Osteoporosis Trial, Recruiting

NCT07027306
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 50 or older who have gone through menopause (defined as having no menstrual periods for one full year), or men aged over 60.
  • People who have been diagnosed with one or more new, painful spine fractures in the mid-to-lower back region (from the upper back down to the lower spine), confirmed by medical imaging such as MRI or CT scan.
  • In cases where more than one spinal level is fractured, the fractures must be next to each other (no gaps between them).
  • People whose spine fracture was caused by primary osteoporosis (bone thinning not caused by another medical condition), confirmed either by a bone density scan result (T-score of -2.5 or lower) or by the nature of the fracture occurring from little or no force (such as a minor fall, trip, or heavy lifting).
  • People whose fracture falls into one of five recognised categories of osteoporotic spine fracture, ranging from bone swelling only (no visible shape change) through to more significant structural changes to the vertebra (confirm with trial site for exact classification details).
  • People who are able to give their informed consent to participate, following the procedures set by the overseeing ethics committee.

Who may not be able to join:

  • People who have a tumour in or around the spine.
  • People who also have a fracture in the neck area of the spine.
  • People who show any signs of a spinal infection.
  • People whose fracture was caused by a high-force event, such as a fall from a significant height, a high-speed car accident, or multiple serious injuries at once.
  • People who also have a fracture in the pelvis, arms, or legs that could affect their ability to move around or their pain levels during the study.
  • People for whom follow-up appointments during the study would not be possible.
  • People who have previously had surgery involving hardware (such as rods, screws, or plates) placed in the affected part of their spine.
  • People whose fracture is at a spinal level directly next to a previously operated area that involved such hardware.
  • People who, due to a mental health condition, would not be able to follow the study procedures or participate in data collection.
  • People who were already confined to bed before their spine fracture occurred.
  • People with a recent history of recreational drug or alcohol misuse that could affect the reliability of assessments.
  • People who have taken part in another clinical trial of a medical device or medication within the past month that could influence the results of this study.

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 27 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: Klaus Schnake, MD, Center for Spinal and Scoliosis Surgery

Phone: +41 79 671 47 98

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
Sponsor
AO Foundation, AO Spine
Registry
ClinicalTrials.gov
Start date
19 March 2026
Est. completion
1 December 2028

Where this trial is recruiting

🇦🇷 Argentina 🇧🇷 Brazil 🇨🇱 Chile 🇪🇬 Egypt 🇫🇮 Finland 🇩🇪 Germany 🇮🇳 India 🇯🇵 Japan 🇲🇾 Malaysia 🇷🇴 Romania 🇸🇦 Saudi Arabia 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Return to mobility

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: 27 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