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
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/56921
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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 |
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CONICET Digital (CONICET) |
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CONICET Digital (CONICET) |
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Consejo Nacional de Investigaciones Científicas y Técnicas |
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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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13.070432 |