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Papers of the Week

Papers: 25 Dec 2021 - 31 Dec 2021

Pharmacology/Drug Development

2021 Dec 26

J Bone Miner Res

Efficacy of Zoledronic Acid in the Treatment of Non-malignant Painful Bone Mar-row Lesions: A Triple-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial (ZoMARS).


Bone marrow lesions (BML) represent areas of deteriorated bone structure and metabolism characterized by pronounced water-equivalent signaling within the trabecular bone on Magnetic Resonance Imaging (MRI). BML are associated with repair mechanisms subsequent to various clinical conditions associated with inflammatory and non-inflammatory injury to the bone. There is no approved treatment for this condition. Bisphosphonates are known to improve bone stability in osteoporosis and other bone disorders and have been used off-label to treat BML. A randomized, triple-blind, placebo-controlled Phase III trial was conducted to assess efficacy and safety of single dose Zoledronic acid (ZOL) 5mg i.v. with Vitamin D 1000 IU/d as opposed to placebo with Vitamin D 1000 IU/d in 48 patients (randomized 2:1) with BML. Primary efficacy endpoint was reduction of edema volume six weeks after treatment as assessed by MRI. Following treatment, mean BML volume decreased by 64.53(±41.92)% in patients receiving Zoledronic acid and increased by 14.43(±150.46)% in the placebo group (p=0.007). A decrease in BML volume was observed in 76.5% of patients receiving ZOL and in 50% of the patients receiving placebo. Pain level (VAS) and all categories of the Pain Disability Index (PDI) improved with ZOL vs placebo after 6 weeks but reconciled after six additional weeks of follow-up. Six SAE occurred in five patients, none of which were classified as related to the study drug. No cases of osteonecrosis or fractures occurred. Therefore single-dose Zoledronic acid 5mg i.v. together with Vitamin D may enhance resolution of bone marrow lesions over 6 weeks along with reduction of pain as compared to Vitamin D supplementation only. This article is protected by copyright. All rights reserved.