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. Attached Files Name Description MIMEType Size Downloads 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 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 Collections: Faculty of Health School of Health and Social Development Related Links Link Description Connect to published version - restricted access Go to link with your DU access privileges   Author URL Go to link with your DU access privileges     Unless expressly stated otherwise, the copyright for items in DRO is owned by the author, with all rights reserved. Versions Version Filter Type Thu, 20 Nov 2014, 10:50:28 EST Fri, 12 Dec 2014, 14:36:59 EST Sat, 13 Dec 2014, 04:00:11 EST Sat, 13 Dec 2014, 05:05:40 EST Fri, 19 Dec 2014, 10:07:39 EST Fri, 19 Dec 2014, 10:14:33 EST Filtered Full Citation counts:   Cited 26 times in TR Web of Science Cited 27 times in Scopus Search Google Scholar Access Statistics: 396 Abstract Views, 2 File Downloads  -  Detailed Statistics Created: Fri, 12 Dec 2014, 14:36:59 EST

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