title: Effects of Romosozumab Compared With Teriparatide on Bone Density and Mass at the Spine and Hip in Postmenopausal Women With Low Bone Mass.
abstract: Romosozumab, a monoclonal antibody that binds sclerostin, has a dual effect on bone by increasing bone formation and reducing bone resorption, and thus has favorable effects in both aspects of bone volume regulation. In a phase 2 study, romosozumab increased areal BMD at the lumbar spine and total hip as measured by DXA compared with placebo, alendronate, and teriparatide in postmenopausal women with low bone mass. In additional analyses from this international, randomized study, we now describe the effect of romosozumab on lumbar spine and hip volumetric BMD (vBMD) and BMC at month 12 as assessed by QCT in the subset of participants receiving placebo, s.c. teriparatide (20 µg once daily), and s.c. romosozumab (210 mg once monthly). QCT measurements were performed at the lumbar spine (mean of L1and L2entire vertebral bodies, excluding posterior processes) and hip. One year of treatment with romosozumab significantly increased integral vBMD and BMC at the lumbar spine and total hip from baseline, and compared with placebo and teriparatide (all p < 0.05). Trabecular vertebral vBMD improved significantly and similarly from baseline (p < 0.05) with both romosozumab (18.3%) and teriparatide (20.1%), whereas cortical vertebral vBMD gains were larger with romosozumab compared with teriparatide (13.7% versus 5.7%, p < 0.0001). Trabecular hip vBMD gains were significantly larger with romosozumab than with teriparatide (10.8% versus 4.2%, p = 0.01), but were similar for cortical vBMD (1.1% versus -0.9%, p = 0.12). Cortical BMC gains were larger with romosozumab compared with teriparatide at both the spine (23.3% versus 10.9%, p < 0.0001) and hip (3.4% versus 0.0%, p = 0.03). These improvements are expected to result in strength gains and support the continued clinical investigation of romosozumab as a potential therapy to rapidly reduce fracture risk in ongoing phase 3 studies. © 2016 American Society for Bone and Mineral Research.
authors.affiliation: University of California, San Francisco (UCSF), San Francisco, CA, USA.|BioClinica-Synarc, San Francisco, CA, USA.
authors.forename: Harry K
authors.initials: HK
authors.lastname: Genant
authors.affiliation: BioClinica, Hamburg, Germany.|Institute of Medical Physics, University of Erlangen, Erlangen, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Engelke
authors.affiliation: The Bethesda Health Research Center, Bethesda, MD, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Bolognese
authors.affiliation: Centro de Osteopatias Medicas, Buenos Aires, Argentina.
authors.forename: Carlos
authors.initials: C
authors.lastname: Mautalen
authors.affiliation: CHU de Québec Research Centre and Laval University, Québec, QC, Canada.
authors.forename: Jacques P
authors.initials: JP
authors.lastname: Brown
authors.affiliation: United Osteoporosis Centers, Gainesville, GA, USA.
authors.forename: Chris
authors.initials: C
authors.lastname: Recknor
authors.affiliation: Department of Endocrinology and Unit for Osteoporosis and Metabolic Bone Diseases, Ghent University Hospital, Ghent, Belgium.
authors.forename: Stefan
authors.initials: S
authors.lastname: Goemaere
authors.affiliation: BioClinica Inc., Newark, CA, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Fuerst
authors.affiliation: Amgen Inc., Thousand Oaks, CA, USA.
authors.forename: Yu-Ching
authors.initials: YC
authors.lastname: Yang
authors.affiliation: Amgen Inc., Thousand Oaks, CA, USA.
authors.forename: Andreas
authors.initials: A
authors.lastname: Grauer
authors.affiliation: UCB BioPharma, Brussels, Belgium.
authors.forename: Cesar
authors.initials: C
authors.lastname: Libanati
mesh_terms: D015502:Absorptiometry, Photon; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000494:pharmacology*; D015519:Bone Density / Q000187:drug effects*; D003710:Demography; D005260:Female; D006615:Hip / Q000033:anatomy & histology* / Q000000981:diagnostic imaging / Q000502:physiology; D006801:Humans; D008159:Lumbar Vertebrae / Q000187:drug effects / Q000502:physiology; D008875:Middle Aged; D009929:Organ Size / Q000187:drug effects; D017698:Postmenopause / Q000187:drug effects*; D013131:Spine / Q000033:anatomy & histology* / Q000000981:diagnostic imaging / Q000502:physiology; D019379:Teriparatide / Q000494:pharmacology*; D014057:Tomography, X-Ray Computed
chemical_list: D000911:Antibodies, Monoclonal; D019379:Teriparatide; C557282:romosozumab
keywords: ANABOLICS; BONE QCT; CLINICAL TRIALS; OSTEOPOROSIS