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Abstract

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.

Item Type:	Article
Authors/Creators:	Cai, G and Laslett, LL and Aitken, D and Cicuttini, F and March, L and Hill, C and Winzenberg, T and Jones, G
Keywords:	acute phase response, bone marrow lesion, methylprednisolone, noninferiority, zoledronic acid
Journal or Publication Title:	Therapeutic Advances in Musculoskeletal Disease
Publisher:	Sage Publications Ltd.
ISSN:	1759-720X
DOI / ID Number:	https://doi.org/10.1177/1759720X19880054
Copyright Information:	© The Author(s), 2019. Licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) https://creativecommons.org/licenses/by-nc/4.0/
Related URLs:	Google Scholar: Laslett, LL UTAS Profile: Laslett, LL Google Scholar: Aitken, D UTAS Profile: Aitken, D Google Scholar: Winzenberg, T UTAS Profile: Winzenberg, T Google Scholar: Jones, G UTAS Profile: Jones, G
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