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Zoledronic acid plus methylprednisolone versus zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized controlled trial
BACKGROUND: The aim of this study was to compare the efficacy and safety of zoledronic acid (ZA) plus intravenous methylprednisolone (VOLT01) to ZA, and placebo for knee osteoarthritis. METHODS: A single-center, double-blind, randomized controlled trial (RCT) was carried out. Adults (aged ⩾50 years)...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6811759/ https://www.ncbi.nlm.nih.gov/pubmed/31692649 http://dx.doi.org/10.1177/1759720X19880054 |
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author | Cai, Guoqi Laslett, Laura L Aitken, Dawn Cicuttini, Flavia March, Lyn Hill, Catherine Winzenberg, Tania Jones, Graeme |
author_facet | Cai, Guoqi Laslett, Laura L Aitken, Dawn Cicuttini, Flavia March, Lyn Hill, Catherine Winzenberg, Tania Jones, Graeme |
author_sort | Cai, Guoqi |
collection | PubMed |
description | BACKGROUND: The aim of this study was to compare the efficacy and safety of zoledronic acid (ZA) plus intravenous methylprednisolone (VOLT01) to ZA, and placebo for knee osteoarthritis. METHODS: A single-center, double-blind, randomized controlled trial (RCT) was carried out. Adults (aged ⩾50 years) with knee osteoarthritis, significant knee pain [⩾40 mm on a 100 mm visual analog scale (VAS)], and magnetic resonance imaging-detected bone marrow lesion (BML) were randomized to receive a one-off administration of VOLT01, ZA, or placebo. The primary hypothesis was that VOLT01 was superior to ZA in having a lower incidence of acute phase responses (APRs) over 3 days. Secondary hypotheses were that VOLT01 was noninferior to ZA, and both treatments were superior to placebo in decreasing BML size over 6 months and in improving knee pain [Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and VAS] and function (WOMAC) over 3 and 6 months. RESULTS: A total of 117 patients (62.2 ± 8.1 years, 63 women) were enrolled. The incidence of APRs was similar in the VOLT01 (90%) and ZA (87%) groups (p = 0.74). VOLT01 was superior to ZA in improving knee pain and function after 6 months and noninferior to ZA in reducing BML size. However, BML size change was small in all groups and there were no between-group differences. Compared with placebo, VOLT01 but not ZA improved knee function and showed a trend toward improving knee pain after 6 months. CONCLUSIONS: Administering intravenous methylprednisolone with ZA did not reduce APRs or change knee BML size over 6 months, but in contrast to ZA or placebo, it may have a beneficial effect on symptoms in knee osteoarthritis. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12613000039785. |
format | Online Article Text |
id | pubmed-6811759 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-68117592019-11-05 Zoledronic acid plus methylprednisolone versus zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized controlled trial Cai, Guoqi Laslett, Laura L Aitken, Dawn Cicuttini, Flavia March, Lyn Hill, Catherine Winzenberg, Tania Jones, Graeme Ther Adv Musculoskelet Dis Original Research BACKGROUND: The aim of this study was to compare the efficacy and safety of zoledronic acid (ZA) plus intravenous methylprednisolone (VOLT01) to ZA, and placebo for knee osteoarthritis. METHODS: A single-center, double-blind, randomized controlled trial (RCT) was carried out. Adults (aged ⩾50 years) with knee osteoarthritis, significant knee pain [⩾40 mm on a 100 mm visual analog scale (VAS)], and magnetic resonance imaging-detected bone marrow lesion (BML) were randomized to receive a one-off administration of VOLT01, ZA, or placebo. The primary hypothesis was that VOLT01 was superior to ZA in having a lower incidence of acute phase responses (APRs) over 3 days. Secondary hypotheses were that VOLT01 was noninferior to ZA, and both treatments were superior to placebo in decreasing BML size over 6 months and in improving knee pain [Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and VAS] and function (WOMAC) over 3 and 6 months. RESULTS: A total of 117 patients (62.2 ± 8.1 years, 63 women) were enrolled. The incidence of APRs was similar in the VOLT01 (90%) and ZA (87%) groups (p = 0.74). VOLT01 was superior to ZA in improving knee pain and function after 6 months and noninferior to ZA in reducing BML size. However, BML size change was small in all groups and there were no between-group differences. Compared with placebo, VOLT01 but not ZA improved knee function and showed a trend toward improving knee pain after 6 months. CONCLUSIONS: Administering intravenous methylprednisolone with ZA did not reduce APRs or change knee BML size over 6 months, but in contrast to ZA or placebo, it may have a beneficial effect on symptoms in knee osteoarthritis. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12613000039785. SAGE Publications 2019-10-23 /pmc/articles/PMC6811759/ /pubmed/31692649 http://dx.doi.org/10.1177/1759720X19880054 Text en © The Author(s), 2019 http://www.creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Original Research Cai, Guoqi Laslett, Laura L Aitken, Dawn Cicuttini, Flavia March, Lyn Hill, Catherine Winzenberg, Tania Jones, Graeme Zoledronic acid plus methylprednisolone versus zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized controlled trial |
title | Zoledronic acid plus methylprednisolone versus
zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized
controlled trial |
title_full | Zoledronic acid plus methylprednisolone versus
zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized
controlled trial |
title_fullStr | Zoledronic acid plus methylprednisolone versus
zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized
controlled trial |
title_full_unstemmed | Zoledronic acid plus methylprednisolone versus
zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized
controlled trial |
title_short | Zoledronic acid plus methylprednisolone versus
zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized
controlled trial |
title_sort | zoledronic acid plus methylprednisolone versus
zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized
controlled trial |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6811759/ https://www.ncbi.nlm.nih.gov/pubmed/31692649 http://dx.doi.org/10.1177/1759720X19880054 |
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