Efficacy of Off-Label Bisphosphonate Use for Edema in Bone Marrow Lesions
Participants in the double-blind placebo-controlled trial were randomly assigned 2:1 to receive either treatment or placebo.
|This article is part of Endocrinology Advisor's coverage of the 2017 American Society for Bone and Mineral Research (ASBMR) Annual Meeting taking place in Denver, CO. Check back regularly for more news on the latest clinical research in bone health from ASBMR 2017.|
Intravenous (IV) zoledronic acid plus vitamin D significantly reduces volume of bone marrow edema in patients with bone marrow lesions, according to research presented at the 2017 American Society for Bone and Mineral Research (ASBMR) Annual Meeting, held September 8-11, 2017 in Denver, Colorado.
Lothar Seefried, MD, of the Orthopedic Institute at University of Wuerzburg in Germany, and colleagues reported data from the phase 3 ZoMARS trial (Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome; ClinicalTrials.gov Identifier NCT01348269), which included 48 patients with bone marrow lesions.
Patients were randomly assigned 2:1 to receive either a single dose of zoledronic acid (5 mg IV plus vitamin D (n=34) or placebo plus vitamin D. The primary study end point was edema volume reduction 6 weeks post-treatment assessed via magnetic resonance imaging (MRI); secondary end points were pain reduction and quality of life.
At the conclusion of treatment, 64.5% of patients showed significantly reduced bone marrow edema volume, while patients in the placebo group experienced an average increase of 14.4%. Although pain levels were improved in the zoledronic acid group vs the placebo group at 6 weeks, pain levels converged after 12 weeks follow-up, which the researchers noted was “most likely due to spontaneous healing in the placebo group.” Of the participants, 5 experienced 6 serious adverse events not related to the study drug. Common adverse events were headache, pain in the extremities, and fatigue (n=13, 11, and 10 patients respectively).
“Single-dose zoledronic acid…may enhance resolution of bone marrow lesions in 6 weeks along with reduction of pain,” concluded Dr Seefried and colleagues. “Treatment-emergent [adverse effects] were in line with known side effects of intravenous bisphosphonates.”
Seefried L, Baumann J, Genst F, Heidemeier A, Meffert R, Jakob F. Prospective, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of zoledronic acid for the treatment of bone marrow lesions – ZoMARS. Presented at: 2017 American Society for Bone and Mineral Research Annual Meeting; September 8-11, 2017; Denver, CO. Abstract 1112.