Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass

Autores
Keaveny, Tony M.; Crittenden, Daria B.; Bolognese, Michael A.; Genant, Harry K.; Engelke, Klaus; Oliveri, María Beatriz; Brown, Jacques P.; Langdahl, Bente L.; Yan, Chris; Grauer, Andreas; Libanati, Cesar
Año de publicación
2017
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Romosozumab is a monoclonal antibody that inhibits sclerostin and has been shown to reduce the risk of fractures within 12 months. In a phase II, randomized, placebo-controlled clinical trial of treatment-naïve postmenopausal women with low bone mass, romosozumab increased bone mineral density (BMD) at the hip and spine by the dual effect of increasing bone formation and decreasing bone resorption. In a substudy of that trial, which included placebo and teriparatide arms, here we investigated whether those observed increases in BMD also resulted in improvements in estimated strength, as assessed by finite element analysis. Participants received blinded romosozumab s.c. (210 mg monthly) or placebo, or open-label teriparatide (20 μg daily) for 12 months. CT scans, obtained at the lumbar spine (n = 82) and proximal femur (n = 46) at baseline and month 12, were analyzed with finite element software (VirtuOst, O.N. Diagnostics) to estimate strength for a simulated compression overload for the spine (L1 vertebral body) and a sideways fall for the proximal femur, all blinded to treatment assignment. We found that, at month 12, vertebral strength increased more for romosozumab compared with both teriparatide (27.3% versus 18.5%; p = 0.005) and placebo (27.3% versus –3.9%; p < 0.0001); changes in femoral strength for romosozumab showed similar but smaller changes, increasing more with romosozumab versus teriparatide (3.6% versus –0.7%; p = 0.027), and trending higher versus placebo (3.6% versus −0.1%; p = 0.059). Compartmental analysis revealed that the bone-strengthening effects for romosozumab were associated with positive contributions from both the cortical and trabecular bone compartments at both the lumbar spine and hip. Taken together, these findings suggest that romosozumab may offer patients with osteoporosis a new bone-forming therapeutic option that increases both vertebral and femoral strength within 12 months.
Fil: Keaveny, Tony M.. University of California at Berkeley; Estados Unidos
Fil: Crittenden, Daria B.. Amgen Inc.; Estados Unidos
Fil: Bolognese, Michael A.. Bethesda Health Research Center; Estados Unidos
Fil: Genant, Harry K.. Synarc; Estados Unidos. University of California; Estados Unidos
Fil: Engelke, Klaus. Universitat Erlangen-Nuremberg; Alemania. Institute of Medical Physics Erlangen Germany; Alemania
Fil: Oliveri, María Beatriz. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Inmunología, Genética y Metabolismo. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Inmunología, Genética y Metabolismo; Argentina. Universidad de Buenos Aires. Facultad de Medicina. Hospital de Clínicas General San Martín; Argentina
Fil: Brown, Jacques P.. Laval University; Canadá
Fil: Langdahl, Bente L.. University Aarhus; Dinamarca
Fil: Yan, Chris. Amgen Ltd.; Reino Unido
Fil: Grauer, Andreas. Amgen Inc.; Estados Unidos
Fil: Libanati, Cesar. Union Chimique Belge; Bélgica
Materia
ANABOLICS
OSTEOPOROSIS
ROMOSOZUMAB
TERIPARATIDE
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/56921

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spelling Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone MassKeaveny, Tony M.Crittenden, Daria B.Bolognese, Michael A.Genant, Harry K.Engelke, KlausOliveri, María BeatrizBrown, Jacques P.Langdahl, Bente L.Yan, ChrisGrauer, AndreasLibanati, CesarANABOLICSOSTEOPOROSISROMOSOZUMABTERIPARATIDEhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Romosozumab is a monoclonal antibody that inhibits sclerostin and has been shown to reduce the risk of fractures within 12 months. In a phase II, randomized, placebo-controlled clinical trial of treatment-naïve postmenopausal women with low bone mass, romosozumab increased bone mineral density (BMD) at the hip and spine by the dual effect of increasing bone formation and decreasing bone resorption. In a substudy of that trial, which included placebo and teriparatide arms, here we investigated whether those observed increases in BMD also resulted in improvements in estimated strength, as assessed by finite element analysis. Participants received blinded romosozumab s.c. (210 mg monthly) or placebo, or open-label teriparatide (20 μg daily) for 12 months. CT scans, obtained at the lumbar spine (n = 82) and proximal femur (n = 46) at baseline and month 12, were analyzed with finite element software (VirtuOst, O.N. Diagnostics) to estimate strength for a simulated compression overload for the spine (L1 vertebral body) and a sideways fall for the proximal femur, all blinded to treatment assignment. We found that, at month 12, vertebral strength increased more for romosozumab compared with both teriparatide (27.3% versus 18.5%; p = 0.005) and placebo (27.3% versus –3.9%; p < 0.0001); changes in femoral strength for romosozumab showed similar but smaller changes, increasing more with romosozumab versus teriparatide (3.6% versus –0.7%; p = 0.027), and trending higher versus placebo (3.6% versus −0.1%; p = 0.059). Compartmental analysis revealed that the bone-strengthening effects for romosozumab were associated with positive contributions from both the cortical and trabecular bone compartments at both the lumbar spine and hip. Taken together, these findings suggest that romosozumab may offer patients with osteoporosis a new bone-forming therapeutic option that increases both vertebral and femoral strength within 12 months.Fil: Keaveny, Tony M.. University of California at Berkeley; Estados UnidosFil: Crittenden, Daria B.. Amgen Inc.; Estados UnidosFil: Bolognese, Michael A.. Bethesda Health Research Center; Estados UnidosFil: Genant, Harry K.. Synarc; Estados Unidos. University of California; Estados UnidosFil: Engelke, Klaus. Universitat Erlangen-Nuremberg; Alemania. Institute of Medical Physics Erlangen Germany; AlemaniaFil: Oliveri, María Beatriz. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Inmunología, Genética y Metabolismo. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Inmunología, Genética y Metabolismo; Argentina. Universidad de Buenos Aires. Facultad de Medicina. Hospital de Clínicas General San Martín; ArgentinaFil: Brown, Jacques P.. Laval University; CanadáFil: Langdahl, Bente L.. University Aarhus; DinamarcaFil: Yan, Chris. Amgen Ltd.; Reino UnidoFil: Grauer, Andreas. Amgen Inc.; Estados UnidosFil: Libanati, Cesar. Union Chimique Belge; BélgicaAmerican Society for Bone and Mineral Research2017-09info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/vnd.openxmlformats-officedocument.wordprocessingml.documentapplication/pdfhttp://hdl.handle.net/11336/56921Keaveny, Tony M.; Crittenden, Daria B.; Bolognese, Michael A.; Genant, Harry K.; Engelke, Klaus; et al.; Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass; American Society for Bone and Mineral Research; Journal of Bone and Mineral Research; 32; 9; 9-2017; 1956-19620884-0431CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1002/jbmr.3176info:eu-repo/semantics/altIdentifier/url/https://onlinelibrary.wiley.com/doi/abs/10.1002/jbmr.3176info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:14:31Zoai:ri.conicet.gov.ar:11336/56921instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 10:14:31.632CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass
title Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass
spellingShingle Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass
Keaveny, Tony M.
ANABOLICS
OSTEOPOROSIS
ROMOSOZUMAB
TERIPARATIDE
title_short Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass
title_full Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass
title_fullStr Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass
title_full_unstemmed Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass
title_sort Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass
dc.creator.none.fl_str_mv Keaveny, Tony M.
Crittenden, Daria B.
Bolognese, Michael A.
Genant, Harry K.
Engelke, Klaus
Oliveri, María Beatriz
Brown, Jacques P.
Langdahl, Bente L.
Yan, Chris
Grauer, Andreas
Libanati, Cesar
author Keaveny, Tony M.
author_facet Keaveny, Tony M.
Crittenden, Daria B.
Bolognese, Michael A.
Genant, Harry K.
Engelke, Klaus
Oliveri, María Beatriz
Brown, Jacques P.
Langdahl, Bente L.
Yan, Chris
Grauer, Andreas
Libanati, Cesar
author_role author
author2 Crittenden, Daria B.
Bolognese, Michael A.
Genant, Harry K.
Engelke, Klaus
Oliveri, María Beatriz
Brown, Jacques P.
Langdahl, Bente L.
Yan, Chris
Grauer, Andreas
Libanati, Cesar
author2_role author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv ANABOLICS
OSTEOPOROSIS
ROMOSOZUMAB
TERIPARATIDE
topic ANABOLICS
OSTEOPOROSIS
ROMOSOZUMAB
TERIPARATIDE
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Romosozumab is a monoclonal antibody that inhibits sclerostin and has been shown to reduce the risk of fractures within 12 months. In a phase II, randomized, placebo-controlled clinical trial of treatment-naïve postmenopausal women with low bone mass, romosozumab increased bone mineral density (BMD) at the hip and spine by the dual effect of increasing bone formation and decreasing bone resorption. In a substudy of that trial, which included placebo and teriparatide arms, here we investigated whether those observed increases in BMD also resulted in improvements in estimated strength, as assessed by finite element analysis. Participants received blinded romosozumab s.c. (210 mg monthly) or placebo, or open-label teriparatide (20 μg daily) for 12 months. CT scans, obtained at the lumbar spine (n = 82) and proximal femur (n = 46) at baseline and month 12, were analyzed with finite element software (VirtuOst, O.N. Diagnostics) to estimate strength for a simulated compression overload for the spine (L1 vertebral body) and a sideways fall for the proximal femur, all blinded to treatment assignment. We found that, at month 12, vertebral strength increased more for romosozumab compared with both teriparatide (27.3% versus 18.5%; p = 0.005) and placebo (27.3% versus –3.9%; p < 0.0001); changes in femoral strength for romosozumab showed similar but smaller changes, increasing more with romosozumab versus teriparatide (3.6% versus –0.7%; p = 0.027), and trending higher versus placebo (3.6% versus −0.1%; p = 0.059). Compartmental analysis revealed that the bone-strengthening effects for romosozumab were associated with positive contributions from both the cortical and trabecular bone compartments at both the lumbar spine and hip. Taken together, these findings suggest that romosozumab may offer patients with osteoporosis a new bone-forming therapeutic option that increases both vertebral and femoral strength within 12 months.
Fil: Keaveny, Tony M.. University of California at Berkeley; Estados Unidos
Fil: Crittenden, Daria B.. Amgen Inc.; Estados Unidos
Fil: Bolognese, Michael A.. Bethesda Health Research Center; Estados Unidos
Fil: Genant, Harry K.. Synarc; Estados Unidos. University of California; Estados Unidos
Fil: Engelke, Klaus. Universitat Erlangen-Nuremberg; Alemania. Institute of Medical Physics Erlangen Germany; Alemania
Fil: Oliveri, María Beatriz. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Inmunología, Genética y Metabolismo. Universidad de Buenos Aires. Facultad de Medicina. Instituto de Inmunología, Genética y Metabolismo; Argentina. Universidad de Buenos Aires. Facultad de Medicina. Hospital de Clínicas General San Martín; Argentina
Fil: Brown, Jacques P.. Laval University; Canadá
Fil: Langdahl, Bente L.. University Aarhus; Dinamarca
Fil: Yan, Chris. Amgen Ltd.; Reino Unido
Fil: Grauer, Andreas. Amgen Inc.; Estados Unidos
Fil: Libanati, Cesar. Union Chimique Belge; Bélgica
description Romosozumab is a monoclonal antibody that inhibits sclerostin and has been shown to reduce the risk of fractures within 12 months. In a phase II, randomized, placebo-controlled clinical trial of treatment-naïve postmenopausal women with low bone mass, romosozumab increased bone mineral density (BMD) at the hip and spine by the dual effect of increasing bone formation and decreasing bone resorption. In a substudy of that trial, which included placebo and teriparatide arms, here we investigated whether those observed increases in BMD also resulted in improvements in estimated strength, as assessed by finite element analysis. Participants received blinded romosozumab s.c. (210 mg monthly) or placebo, or open-label teriparatide (20 μg daily) for 12 months. CT scans, obtained at the lumbar spine (n = 82) and proximal femur (n = 46) at baseline and month 12, were analyzed with finite element software (VirtuOst, O.N. Diagnostics) to estimate strength for a simulated compression overload for the spine (L1 vertebral body) and a sideways fall for the proximal femur, all blinded to treatment assignment. We found that, at month 12, vertebral strength increased more for romosozumab compared with both teriparatide (27.3% versus 18.5%; p = 0.005) and placebo (27.3% versus –3.9%; p < 0.0001); changes in femoral strength for romosozumab showed similar but smaller changes, increasing more with romosozumab versus teriparatide (3.6% versus –0.7%; p = 0.027), and trending higher versus placebo (3.6% versus −0.1%; p = 0.059). Compartmental analysis revealed that the bone-strengthening effects for romosozumab were associated with positive contributions from both the cortical and trabecular bone compartments at both the lumbar spine and hip. Taken together, these findings suggest that romosozumab may offer patients with osteoporosis a new bone-forming therapeutic option that increases both vertebral and femoral strength within 12 months.
publishDate 2017
dc.date.none.fl_str_mv 2017-09
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/56921
Keaveny, Tony M.; Crittenden, Daria B.; Bolognese, Michael A.; Genant, Harry K.; Engelke, Klaus; et al.; Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass; American Society for Bone and Mineral Research; Journal of Bone and Mineral Research; 32; 9; 9-2017; 1956-1962
0884-0431
CONICET Digital
CONICET
url http://hdl.handle.net/11336/56921
identifier_str_mv Keaveny, Tony M.; Crittenden, Daria B.; Bolognese, Michael A.; Genant, Harry K.; Engelke, Klaus; et al.; Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass; American Society for Bone and Mineral Research; Journal of Bone and Mineral Research; 32; 9; 9-2017; 1956-1962
0884-0431
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.1002/jbmr.3176
info:eu-repo/semantics/altIdentifier/url/https://onlinelibrary.wiley.com/doi/abs/10.1002/jbmr.3176
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/vnd.openxmlformats-officedocument.wordprocessingml.document
application/pdf
dc.publisher.none.fl_str_mv American Society for Bone and Mineral Research
publisher.none.fl_str_mv American Society for Bone and Mineral Research
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
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instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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