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Zoledronic acid plus methylprednisolone versus zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized controlled trial.

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. Trial registration:Australian New Zealand Clinical Trials Registry: ACTRN12613000039785.

SUBMITTER: Cai G

PROVIDER: S-EPMC6811759 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Zoledronic acid plus methylprednisolone <i>versus</i> zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized controlled trial.

Cai Guoqi G Laslett Laura L LL Aitken Dawn D Cicuttini Flavia F March Lyn L Hill Catherine C Winzenberg Tania T Jones Graeme G

Therapeutic advances in musculoskeletal disease 20191023

<h4>Background</h4>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.<h4>Methods</h4>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 receiv ...[more]

PMID: 31692649

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Dataset Information

Zoledronic acid plus methylprednisolone versus zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized controlled trial.

Publications

Zoledronic acid plus methylprednisolone <i>versus</i> zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized controlled trial.

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