{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T15:28:12Z","timestamp":1783524492671,"version":"3.55.0"},"reference-count":25,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2021,9,6]],"date-time":"2021-09-06T00:00:00Z","timestamp":1630886400000},"content-version":"unspecified","delay-in-days":5,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100006356","name":"Syddansk Universitet","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100006356","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,8,2]]},"published-print":{"date-parts":[[2021,9]]},"abstract":"\n Introduction<\/jats:title>\n Multiple myeloma (MM) is a plasma cell cancer where about 1\/3 of the patients present with pathological fractures at the time of diagnosis. Despite treatment, the majority of the patients will develop additional fractures. Because survival and prognosis has improved significantly over the last two decades for patients with MM, there is an increased need to focus on optimal fracture treatment. Traditionally, fracture pain is treated conservatively with opioids, bisphosphonates, bracing and radiation therapy. Vertebral augmentation has been used for the last three decades as a minimally invasive treatment option for vertebral compression fractures, but the evidence base for the efficacy is weak. We describe a trial assessing the impact of vertebroplasty on clinical outcome in the treatment of patients with MM with painful vertebral fractures.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n 100 patients with MM with painful vertebral fractures will be randomised in a prospective, single-blinded, multicentre, clinical trial where patients are randomised to either usual care or usual care supplemented with vertebroplasty with a possibility of crossover 4 weeks after randomisation. The primary outcome will be change in Oswestry Disability Index at 4 weeks.<\/jats:p>\n <\/jats:sec>\n \n Analysis<\/jats:title>\n Primary and secondary outcomes are assessed at baseline and at 4, 8, 26 and 52 weeks. Categorical data will be presented by means of frequencies and related percentages; continuous data will be displayed by means of descriptive statistics.<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n The study has been evaluated by the Regional Committees on Health Research for Southern Denmark (S-20200075) and notified and approved by the Region of Southern Denmark and listed in the internal record, journal no. 20\/22355. All participants provide consent. The protocol will follow the SPIRIT (Standard Protocol Items for Randomized Trials) statement. The Danish Myeloma Patient Organization supports the study. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n NCT04533217<\/jats:ext-link>.<\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-045854","type":"journal-article","created":{"date-parts":[[2021,9,6]],"date-time":"2021-09-06T12:23:39Z","timestamp":1630931019000},"page":"e045854","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Vertebroplasty in patients with multiple myeloma with vertebral compression fractures: protocol for a single-blind randomised controlled trial"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct04533217","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3238-4259","authenticated-orcid":false,"given":"Line Adsboell","family":"Wickstroem","sequence":"first","affiliation":[{"name":"Center for Spine Surgery and Research, Sygehus Lillebalt Middelfart Sygehus, Middelfart, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leah","family":"Carreon","sequence":"additional","affiliation":[{"name":"Center for Spine Surgery and Research, Sygehus Lillebalt Middelfart Sygehus, Middelfart, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Lund","sequence":"additional","affiliation":[{"name":"Department of Haematology, Odense University Hospital, Odense, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niels","family":"Abildgaard","sequence":"additional","affiliation":[{"name":"Department of Haematology, Odense University Hospital, Odense, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianne Dyrby","family":"Lorenzen","sequence":"additional","affiliation":[{"name":"Center for Spine Surgery and Research, Sygehus Lillebalt Middelfart Sygehus, Middelfart, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikkel \u00d8sterheden","family":"Andersen","sequence":"additional","affiliation":[{"name":"Center for Spine Surgery and Research, Sygehus Lillebalt Middelfart Sygehus, Middelfart, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,9,6]]},"reference":[{"key":"2025101810133401000_11.9.e045854.1","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1016\/j.morpho.2015.03.002","article-title":"The multiple myeloma bone eco-system and its relation to oncogenesis","volume":"99","author":"Bataille","year":"2015","journal-title":"Morphologie"},{"key":"2025101810133401000_11.9.e045854.2","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2019.230011"},{"key":"2025101810133401000_11.9.e045854.3","article-title":"Pain reduction after percutaneous vertebroplasty for myeloma-associated vertebral fractures","volume":"61","author":"Simony","year":"2014","journal-title":"Dan Med J"},{"key":"2025101810133401000_11.9.e045854.4","doi-asserted-by":"crossref","DOI":"10.1038\/s41408-019-0187-7","article-title":"The role of cement augmentation with percutaneous vertebroplasty and balloon kyphoplasty for the treatment of vertebral compression fractures in multiple myeloma: a consensus statement from the International myeloma Working Group (IMWG)","volume":"9","author":"Kyriakou","year":"2019","journal-title":"Blood Cancer J"},{"key":"2025101810133401000_11.9.e045854.5","doi-asserted-by":"crossref","first-page":"1807","DOI":"10.1002\/cam4.1128","article-title":"The impact of comorbidity on mortality in multiple myeloma: a Danish nationwide population-based study","volume":"6","author":"Gregersen","year":"2017","journal-title":"Cancer Med"},{"key":"2025101810133401000_11.9.e045854.6","doi-asserted-by":"publisher","DOI":"10.1007\/s001980050178"},{"key":"2025101810133401000_11.9.e045854.7","first-page":"166","article-title":"[Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty]","volume":"33","author":"Galibert","year":"1987","journal-title":"Neurochirurgie"},{"key":"2025101810133401000_11.9.e045854.8","doi-asserted-by":"crossref","first-page":"223","DOI":"10.1053\/tvir.2002.36431","article-title":"Percutaneous vertebroplasty: a to Z","volume":"5","author":"Zoarski","year":"2002","journal-title":"Tech Vasc Interv Radiol"},{"key":"2025101810133401000_11.9.e045854.9","doi-asserted-by":"crossref","DOI":"10.1186\/s12885-016-2495-7","article-title":"Spinal disease in myeloma: cohort analysis at a specialist spinal surgery centre indicates benefit of early surgical augmentation or bracing","volume":"16","author":"Malhotra","year":"2016","journal-title":"BMC Cancer"},{"key":"2025101810133401000_11.9.e045854.10","doi-asserted-by":"crossref","first-page":"263","DOI":"10.5152\/dir.2016.15201","article-title":"Effectiveness of percutaneous vertebroplasty in patients with multiple myeloma having vertebral pain","volume":"22","author":"Nas","year":"2016","journal-title":"Diagn Interv Radiol"},{"key":"2025101810133401000_11.9.e045854.11","doi-asserted-by":"publisher","DOI":"10.14444\/5070"},{"key":"2025101810133401000_11.9.e045854.12","doi-asserted-by":"crossref","first-page":"1067","DOI":"10.1016\/j.spinee.2019.02.012","article-title":"Vertebroplasty or kyphoplasty as palliative treatment for cancer-related vertebral compression fractures: a systematic review","volume":"19","author":"S\u00f8rensen","year":"2019","journal-title":"The Spine Journal"},{"key":"2025101810133401000_11.9.e045854.13","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvir.2008.08.014"},{"key":"2025101810133401000_11.9.e045854.14","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0900429"},{"key":"2025101810133401000_11.9.e045854.15","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0900563"},{"key":"2025101810133401000_11.9.e045854.16","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD006349.pub3"},{"key":"2025101810133401000_11.9.e045854.17","unstructured":"Danish Society of Spinal Surgery, 2020. Danish national guideline on treatment of multiple myeloma patients with vertebroplasty Danish Society of Spinal Surgery. Available: http:\/\/drks.ortopaedi.dk\/wp-content\/uploads\/2020\/02\/NKR-for-perkutan-vertebroplastik-til-palliativ-behandling-af-maligne-sammenfald-i-ryggen.pdf [Accessed 27 Aug 2021]."},{"key":"2025101810133401000_11.9.e045854.18","doi-asserted-by":"crossref","first-page":"1573","DOI":"10.1007\/s00586-020-06392-w","article-title":"Percutaneous vertebroplasty as treatment of malignant vertebral lesions: a systematic review and grade evaluation resulting in a Danish national clinical guideline","volume":"29","author":"Rousing","year":"2020","journal-title":"Eur Spine J"},{"key":"2025101810133401000_11.9.e045854.19","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(11)70008-0"},{"key":"2025101810133401000_11.9.e045854.20","doi-asserted-by":"crossref","DOI":"10.1186\/s13013-016-0107-6","article-title":"Comparison if the addition of multilevel vertebral augmentation to conventional therapy will improve the outcome of patients with multiple myeloma","volume":"11","author":"Audat","year":"2016","journal-title":"Scoliosis"},{"key":"2025101810133401000_11.9.e045854.21","unstructured":"Spirit. Standard protocol items: recommendations for interventional trials guideline The SPIRIT group. Available: https:\/\/www.spirit-statement.org\/publications-downloads\/ [Accessed 23 Mar 2020]."},{"key":"2025101810133401000_11.9.e045854.22","unstructured":"Danish health authority, 2016. Danish national guideline on treatment of multiple myeloma Danish Health Authority. Available: https:\/\/www.sst.dk\/-\/media\/Udgivelser\/2019\/Pakkeforloeb-kraeft-2015-2019\/Myelomatose-2016\/Pakkeforl%C3%B8b-for-myelomatose-%E2%80%93-revision-sep-2016_endelig.ashx?la=da&hash=45E5D966276C45B1DEC5B9D4749CE98E37B3EC0A [Accessed 11 Mar 2021]."},{"key":"2025101810133401000_11.9.e045854.23","doi-asserted-by":"publisher","DOI":"10.1097\/00007632-200011150-00017"},{"key":"2025101810133401000_11.9.e045854.24","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-11-110"},{"key":"2025101810133401000_11.9.e045854.25","unstructured":"The Danish code of conduct for research integrity \u2014 Uddannelses- OG Forskningsministeriet. Available: http:\/\/ufm.dk\/publikationer\/2014\/the-danish-code-of-conduct-for-research-integrity"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2020-045854","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T17:13:45Z","timestamp":1760807625000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2020-045854"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,9]]},"references-count":25,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2021,9,6]]},"published-print":{"date-parts":[[2021,9]]}},"alternative-id":["10.1136\/bmjopen-2020-045854"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2020-045854","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,9]]}}}