Loss of lower extremity bone mineral density 1 year after denosumab is discontinued in persons with subacute spinal cord injury.

Autor: Cirnigliaro CM; Department of Veterans Affairs Rehabilitation Research and Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, 130 West Kingsbridge Road, Bronx, NY, 10468, USA. christopher.cirnigliaro@gmail.com., La Fountaine MF; Department of Veterans Affairs Rehabilitation Research and Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, 130 West Kingsbridge Road, Bronx, NY, 10468, USA.; Department of Physical Therapy, School of Health and Medical Sciences, Seton Hall University, South Orange, NJ, USA.; Departments of Medical Sciences and Neurology, Hackensack Meridian School of Medicine, Nutley, NJ, USA., Parrott JS; Department of Interdisciplinary Studies, School of Health Professions, Rutgers Biomedical and Health Sciences, Newark, NJ, USA., Kirshblum SC; Kessler Institute for Rehabilitation, West Orange, NJ, USA.; Kessler Foundation Research Center, West Orange, NJ, USA.; Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School, Newark, NJ, USA., Sauer SJ; Kessler Institute for Rehabilitation, West Orange, NJ, USA., Shapses SA; Department of Nutritional Sciences, Rutgers University, New Brunswick, NJ, USA.; Department of Medicine, Rutgers-Robert Wood Johnson Medical School, NJ, New Brunswick, USA., McClure IA; DP Clinical, Inc, Rockville, MD, USA., Bauman WA; Departments of Medicine and Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Jazyk: angličtina
Zdroj: Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA [Osteoporos Int] 2023 Apr; Vol. 34 (4), pp. 741-748. Date of Electronic Publication: 2023 Feb 03.
DOI: 10.1007/s00198-023-06679-w
Abstrakt: Twelve months following discontinuation of denosumab, the percent decrease in mean bone mineral density (BMD) values at the hip and knee regions were similar between both the denosumab and placebo groups. These findings emphasize the need for additional trials to understand the effect of continued administration of denosumab after subacute spinal cord injury (SCI) to avoid this demineralization.
Objective: To determine changes in BMD 1 year after denosumab was discontinued in participants with subacute SCI who had drug treatment initiated within 90 days post SCI and continued for 1 year.
Methods: Fourteen participants who completed a randomized, double-blinded, placebo-controlled drug trial (parent study: denosumab 60 mg (Prolia, Amgen Inc., n = 8) or placebo (n = 6); administered at baseline, 6, and 12 months) were followed 12 months after the 18 months from baseline primary end point was completed. The BMD of skeletal regions below the SCI at higher risk of fracture was measured [total hip, distal femur epiphysis (DFE), distal femur metaphysis (DFM), and proximal tibia epiphysis (PTE)] by dual energy X-ray absorptiometry.
Results: The percent decreases in mean BMD values at all regions of the hip and knee from 18 to 30 months were similar in both the denosumab and placebo groups. However, at 30 months, the absolute values for mean BMD remained significantly higher in the drug treatment than that of the placebo group at the DFM (p = 0.03), DFE (p = 0.04), and PTE (p = 0.05).
Conclusions: In persons with SCI who initiated denosumab treatment during the subacute injury phase and maintained treatment for 1 year, the discontinuation of drug resulted in percent loss of mean BMD similar to that of the placebo group, with absolute mean BMD values at the knee regions at the 12-month follow-up visit significantly higher in the drug treatment than those in the placebo group. These data underscore the need to study continued administration of denosumab after subacute SCI to avoid marked demineralization in the sublesional skeleton upon discontinuation of this agent.
(© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)
Databáze: MEDLINE
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