Phase 3
Completed N=131
Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
Spinal Fractures · Osteoporosis
Source: ClinicalTrials.gov NCT00068822 ↗
Enrolled (actual)
131
Serious AEs
1.6%
Results posted
Sep 2012
Primary outcomePrimary: 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
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.
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 |
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. Informational only — not medical advice.