{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,12]],"date-time":"2025-11-12T03:18:02Z","timestamp":1762917482376,"version":"3.37.3"},"reference-count":43,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2013,12,11]],"date-time":"2013-12-11T00:00:00Z","timestamp":1386720000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2014,6,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n               <jats:sec>\n                  <jats:title>\u2003<\/jats:title>\n                  <jats:p>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\u2009=\u200978) were randomly assigned to receive either vertebroplasty (n\u2009=\u200938) or a sham procedure (n\u2009=\u200940). Randomization was stratified by treatment center, sex, and symptom duration (&amp;lt;6 weeks or \u22656 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\u2009\u00b1\u20092.7 (mean\u2009\u00b1\u2009SD) units in overall pain compared with 1.9\u2009\u00b1\u20092.8 units in the sham group, adjusted between-group mean difference (MD) 0.3 (95% confidence interval [CI], \u20130.9 to 1.5), whereas at 24 months participants in the active group had improved by 3.0\u2009\u00b1\u20093.1 units compared with 1.9\u2009\u00b1\u20093.0 units in the sham group, MD 1.1 (95% CI, \u20130.3 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\u2009=\u200914, sham: n\u2009=\u200913), 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. \u00a9 2014 American Society for Bone and Mineral Research.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1002\/jbmr.2157","type":"journal-article","created":{"date-parts":[[2013,12,11]],"date-time":"2013-12-11T12:16:39Z","timestamp":1386764199000},"page":"1346-1355","source":"Crossref","is-referenced-by-count":44,"title":["Two-Year Results of a Randomized Placebo-Controlled Trial of Vertebroplasty for Acute Osteoporotic Vertebral Fractures"],"prefix":"10.1093","volume":"29","author":[{"given":"F\u00e9line","family":"Kroon","sequence":"first","affiliation":[{"name":"Department of RheumatologyLeiden University Medical CentreLeidenthe Netherlands"},{"name":"Monash Department of Clinical EpidemiologyCabrini InstituteVictoriaAustralia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margaret","family":"Staples","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive MedicineMonash UniversityVictoriaAustralia"},{"name":"Monash Department of Clinical EpidemiologyCabrini InstituteVictoriaAustralia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter R","family":"Ebeling","sequence":"additional","affiliation":[{"name":"NorthWest Academic CentreUniversity of MelbourneWestern HealthVictoriaAustralia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John D","family":"Wark","sequence":"additional","affiliation":[{"name":"University of Melbourne Department of Medicineand Bone and Mineral MedicineRoyal Melbourne HospitalVictoriaAustralia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard H","family":"Osborne","sequence":"additional","affiliation":[{"name":"Public Health Innovation, Population Health Strategic Research CentreDeakin UniversityVictoriaAustralia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter J","family":"Mitchell","sequence":"additional","affiliation":[{"name":"University of MelbourneDepartment of RadiologyRoyal Melbourne HospitalVictoriaAustralia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chris HR","family":"Wriedt","sequence":"additional","affiliation":[{"name":"I-Med NetworkVictoriaAustralia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0597-0933","authenticated-orcid":false,"given":"Rachelle","family":"Buchbinder","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive MedicineMonash UniversityVictoriaAustralia"},{"name":"Monash Department of Clinical EpidemiologyCabrini InstituteVictoriaAustralia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2013,12,11]]},"reference":[{"key":"2024020318522765600_jbmr2157-bib-0001","first-page":"555","article-title":"Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS Study","volume":"28","author":"Voormolen","year":"2007","journal-title":"AJNR Am J Neuroradiol."},{"key":"2024020318522765600_jbmr2157-bib-0002","doi-asserted-by":"crossref","first-page":"1349","DOI":"10.1097\/BRS.0b013e3181a4e628","article-title":"Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-months follow-up in a clinical randomized study","volume":"34","author":"Rousing","year":"2009","journal-title":"Spine."},{"key":"2024020318522765600_jbmr2157-bib-0003","doi-asserted-by":"crossref","first-page":"557","DOI":"10.1056\/NEJMoa0900429","article-title":"A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures","volume":"361","author":"Buchbinder","year":"2009","journal-title":"N Engl J Med."},{"key":"2024020318522765600_jbmr2157-bib-0004","doi-asserted-by":"crossref","first-page":"569","DOI":"10.1056\/NEJMoa0900563","article-title":"A randomized trial of vertebroplasty for osteoporotic spinal fractures","volume":"361","author":"Kallmes","year":"2009","journal-title":"N Engl J Med."},{"issue":"9746","key":"2024020318522765600_jbmr2157-bib-0005","doi-asserted-by":"crossref","first-page":"1085","DOI":"10.1016\/S0140-6736(10)60954-3","article-title":"Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial","volume":"376","author":"Klazen","year":"2010","journal-title":"Lancet."},{"key":"2024020318522765600_jbmr2157-bib-0006","doi-asserted-by":"crossref","first-page":"561","DOI":"10.3171\/2010.12.SPINE10286","article-title":"Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fractures","volume":"14","author":"Farrokhi","year":"2011","journal-title":"J Neurosurg Spine."},{"key":"2024020318522765600_jbmr2157-bib-0007","doi-asserted-by":"crossref","first-page":"1159","DOI":"10.1002\/jbmr.1564","article-title":"Effect of vertebroplasty on pain relief, quality of life, and the incidence of new vertebral fractures: a 12-month randomized follow-up, controlled trial","volume":"27","author":"Blasco","year":"2012","journal-title":"J Bone Miner Res."},{"key":"2024020318522765600_jbmr2157-bib-0008","doi-asserted-by":"crossref","first-page":"d3952","DOI":"10.1136\/bmj.d3952","article-title":"Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis","volume":"342","author":"Staples","year":"2011","journal-title":"BMJ."},{"key":"2024020318522765600_jbmr2157-bib-0009","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1186\/1471-2474-9-156","article-title":"Efficacy and safety of vertebroplasty for treatment of painful osteoporotic spinal fractures: a randomised controlled trial","volume":"9","author":"Buchbinder","year":"2008","journal-title":"BMC Musculoskel."},{"key":"2024020318522765600_jbmr2157-bib-0010","doi-asserted-by":"crossref","first-page":"1137","DOI":"10.1002\/jbmr.5650080915","article-title":"Vertebral fracture assessment using a semiquantitative technique","volume":"8","author":"Genant","year":"1993","journal-title":"J Bone Miner Res."},{"key":"2024020318522765600_jbmr2157-bib-0011","doi-asserted-by":"crossref","first-page":"E492","DOI":"10.1097\/01.brs.0000143664.02702.0b","article-title":"Concurrent comparison of responsiveness in pain and functional status measurements used for patients with low back pain","volume":"29","author":"Grotle","year":"2004","journal-title":"Spine."},{"key":"2024020318522765600_jbmr2157-bib-0012","first-page":"768","article-title":"Measurement of pain","volume":"9","author":"Huskisson","year":"1982","journal-title":"J Rheumatol."},{"key":"2024020318522765600_jbmr2157-bib-0013","first-page":"2652","article-title":"Evaluation of vertebroplasty with a validated outcome measure: the Roland-Morris Disability Questionnaire","volume":"26","author":"Trout","year":"2005","journal-title":"AJNR Am J Neuroradiol."},{"key":"2024020318522765600_jbmr2157-bib-0014","doi-asserted-by":"crossref","first-page":"150","DOI":"10.1007\/s001980050210","article-title":"Quality of life in patients with vertebral fractures: validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). 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