Administration of Denosumab Preserves Bone Mineral Density at the Knee in Persons With Subacute Spinal Cord Injury: Findings From a Randomized Clinical Trial

• Published in: JBMR plus 2020-08, Vol.4 (8), p.e10375-n/a
• Main Authors: Cirnigliaro, Christopher M, La Fountaine, Michael F, Parrott, J Scott, Kirshblum, Steven C, McKenna, Cristin, Sauer, Susan J, Shapses, Sue A., Hao, Lihong, McClure, Isa A, Hobson, Joshua C, Spungen, Ann M, Bauman, William A
• Format: Article
• Language: English
• Subjects: Bone density; Bone mineral content; BONE MINERAL DENSITY; Clinical trials; Computed tomography; DENOSUMAB; DUAL ENERGY X‐RAY ABSORPTIOMETRY; Enrollments; Epiphysis; Femur; Fractures; Geometry; IMMOBILIZATION OSTEOPOROSIS; Immunoglobulin G; Immunotherapy; Knee; Laboratories; Metaphysis; Monoclonal antibodies; Original; PERIPHERAL QUANTITATIVE COMPUTED TOMOGRAPHY; Spinal cord injuries; SPINAL CORD INJURY; Tibia; TRANCE protein; Vitamin D
• ISSN: 2473-4039; 2473-4039
• DOI: 10.1002/jbm4.10375

ABSTRACT Persons with neurologically motor‐complete spinal cord injury (SCI) have a marked loss of bone mineral density (BMD) of the long bones of the lower extremities, predisposing them to fragility fractures, especially at the knee. Denosumab, a commercially available human monoclonal IgG antibody to receptor activator of nuclear factor‐κB ligand (RANKL), may provide an immunopharmacological solution to the rapid progressive deterioration of sublesional bone after SCI. Twenty‐six SCI participants with subacute motor‐complete SCI were randomized to receive either denosumab (60 mg) or placebo at baseline (BL), 6, and 12 months. Areal bone mineral density (aBMD) by dual energy x‐ray absorptiometry (DXA) at 18 months at the distal femur was the primary outcome and aBMD of the proximal tibia and hip were the secondary outcomes analyzed in 18 of the 26 participants (denosumab, n = 10 and placebo, n = 8). The metrics of peripheral QCT (pQCT) were the exploratory outcomes analyzed in a subsample of the cohort (denosumab, n = 7 and placebo n = 7). The mean aBMD (±95% CI) for the denosumab versus the placebo groups demonstrated a significant group × time interactions for the following regions of interest at BL and 18 months: distal femoral metaphysis = mean aBMD 1.187; 95% CI, 1.074 to 1.300 and mean aBMD 1.202; 95% CI, 1.074 to 1.329 versus mean aBMD 1.162; 95% CI, 0.962 to 1.362 and mean aBMD 0.961; 95% CI, 0.763 to 1.159, respectively (p