Spine procedure put to the test against sham for osteoporosis fracture pain
NCT ID NCT01537770
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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52 people
The number who actually took part.
- Start date
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Feb 2012
- Finished
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Apr 2015
- Lead sponsor
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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
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Middelfart Spinesurgery research department
Middelfart, Region Syddanmark, 5500, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could a simple education program stop the cycle of fractures in the elderly?
- Virtual fitness and nutrition program aims to keep older men on their feet
- New scoring system aims to help osteoporosis patients walk again faster after spine fractures
- New ultrasound scan could predict fracture risk without radiation
- New study aims to find best drug sequence to stop bone breaks
- Simple phone calls may prevent second fractures in seniors