Phase 3
N=131
Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
Spinal Fractures · Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00068822 ↗Enrolled (actual)
131
Serious AEs
1.6%
Results posted
Sep 2012
Primary outcome: Primary: Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month — 12.0; 13.0 units on a scale — p=0.49
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Percutaneous vertebroplasty (Device); Sham vertebroplasty (Procedure)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month |
12.0; 13.0 | 0.49 |
| PRIMARY Patient's Rating of Average Pain at 1 Month |
3.9; 4.6 | 0.19 |
| SECONDARY Patient Well-being at 1 Month |
29.7; 28.7; 46.9; 45.6; 2.1; 2.3 | 0.45 |
Summary
Vertebroplasty is a procedure used to stabilize broken vertebrae, the bones that form the spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of fractures due to osteoporosis.
Eligibility Criteria
Inclusion Criteria
- Confirmed osteoporosis or osteopenia by a referring physician and/or medical history and physical exam OR osteopenia on plain film
- Vertebral compression fracture in vertebrae T4 through L5, of less than 1 year old
- Pain not responsive to standard medical therapy
- Current rating for pain intensity of at least 3 on a scale of 0 to 10
Exclusion Criteria
- Evidence or suspicion of malignant tumor or spinal canal compromise
- Concomitant hip fracture
- Local or systemic infection
- Uncorrectable bleeding diatheses
- Surgery within the previous 60 days
- Lack of access to telephone
- Inability to communicate in English
- Dementia
- Pregnancy
- Abnormal renal function or anticipated venography
- Conscious sedation is contraindicated for subject
Data sourced from ClinicalTrials.gov (NCT00068822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.