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Spine procedure put to the test against sham for osteoporosis fracture pain

NCT ID NCT01537770

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a procedure called vertebroplasty (injecting cement into a broken spine bone) relieves pain better than a sham (fake) procedure in people with osteoporosis. 52 adults aged 50 and older with recent spine fractures took part. The main goal was to measure pain relief and quality of life over a year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

52 people

The number who actually took part.

Start date

Feb 2012

Finished

Apr 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * VCF on X-ray of the spine (minimal 15% loss of height) level of VCF Th6 or lower * back pain ≤ 8 weeks at time of surgery * ≥ 50 years of age * bone edema on MRI of the fractured vertebral body * focal tenderness on VCF level Exclusion Criteria: * severe cardio-pulmonary condition * untreatable coagulopathy * systemic or local infection of the spine (osteomyelitis, spondylodiscitis) * suspected alternative underlying disease (malignancy) * radicular and/or cauda compression syndrome * contra-indication for MRI

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Conditions

The condition(s) this trial relates to.

Osteoporotic Fractures spinal fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Middelfart Spinesurgery research department

    Middelfart, Region Syddanmark, 5500, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.