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Two-year results of a randomized placebo-controlled trial of vertebroplasty for acute osteoporotic vertebral fractures

Kroon, F, Staples, M, Ebeling, P R, Wark, J D, Osborne, R H, Mitchell, P J, Wriedt, C H and Buchbinder, R 2014, Two-year results of a randomized placebo-controlled trial of vertebroplasty for acute osteoporotic vertebral fractures, Journal of bone and mineral research, vol. 29, no. 6, pp. 1346-1355, doi: 10.1002/jbmr.2157.

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Title Two-year results of a randomized placebo-controlled trial of vertebroplasty for acute osteoporotic vertebral fractures
Author(s) Kroon, F
Staples, M
Ebeling, P R
Wark, J D
Osborne, R HORCID iD for Osborne, R H orcid.org/0000-0002-9081-2699
Mitchell, P J
Wriedt, C H
Buchbinder, R
Journal name Journal of bone and mineral research
Volume number 29
Issue number 6
Start page 1346
End page 1355
Total pages 10
Publisher Wiley-Blackwell
Place of publication Malden, MA
Publication date 2014-06
ISSN 1523-4681
Keyword(s) CLINICAL TRIALS
INJURY/FRACTURE HEALING
OSTEOPOROSIS
THERAPEUTICS
Science & Technology
Life Sciences & Biomedicine
Endocrinology & Metabolism
INJURY
FRACTURE HEALING
QUALITY-OF-LIFE
PERCUTANEOUS VERTEBROPLASTY
COMPRESSION FRACTURES
CONSERVATIVE THERAPY
CLINICAL UTILITY
OUTCOMES
PAIN
QUESTIONNAIRE
VERTOS
RISK
Summary We previously reported the results of a randomized controlled trial that found no benefit of vertebroplasty over a sham procedure for acute osteoporotic vertebral fractures up to 6 months. We report here the 12-month and 24-month clinical outcomes of this trial. Eligible participants (n = 78) were randomly assigned to receive either vertebroplasty (n = 38) or a sham procedure (n = 40). Randomization was stratified by treatment center, sex, and symptom duration (<6 weeks or ≥6 weeks). Participants, investigators (except the treating radiologists), and outcome assessors were blinded to group assignments. Enrolment occurred between April 2004 and October 2008 with follow-up completed October 2010. The primary outcome was overall pain measured on a scale of 0 (no pain) to 10 (maximal imaginable pain). Secondary outcomes included pain at rest and at night, disability, quality of life, perceived recovery, and adverse events, including incident clinically apparent vertebral fractures. At 12 and 24 months, complete data were available for 67 (86%) and 57 (73%) participants, respectively. At 12 months participants in the active group improved by 2.4 ± 2.7 (mean ± SD) units in overall pain compared with 1.9 ± 2.8 units in the sham group, adjusted between-group mean difference (MD) 0.3 (95% confidence interval [CI], –0.9 to 1.5), whereas at 24 months participants in the active group had improved by 3.0 ± 3.1 units compared with 1.9 ± 3.0 units in the sham group, MD 1.1 (95% CI, –0.3 to 2.4). No significant between-group differences were observed for any of the secondary efficacy outcomes at 12 or 24 months. There were no between-group differences in incident clinical vertebral fractures up to 24 months (active: n = 14, sham: n = 13), although the study had inadequate power for this outcome. These results provide further evidence that the use of this treatment in routine care is unsupported.
Language eng
DOI 10.1002/jbmr.2157
Field of Research 119999 Medical and Health Sciences not elsewhere classified
Socio Economic Objective 920599 Specific Population Health (excl. Indigenous Health) not elsewhere classified
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2014, Wiley-Blackwell
Persistent URL http://hdl.handle.net/10536/DRO/DU:30067581

Document type: Journal Article
Collection: School of Health and Social Development
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Created: Fri, 12 Dec 2014, 14:36:59 EST

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