Relationship between bone mineral density changes with denosumab treatment and risk reduction for vertebral and nonvertebral fractures

Autor: Austin, M, Yang, Yc, Vittinghoff, E, Adami, Silvano, Boonen, S, Bauer, Dc, Bianchi, G, Bolognese, Ma, Christiansen, C, Eastell, R, Grauer, A, Hawkins, F, Kendler, Dl, Oliveri, B, Mcclung, Mr, Reid, Ir, Siris, Es, Zanchetta, J, Zerbini, Ca, Libanati, C, Cummings, Sr, Freedom, Trial
Rok vydání: 2012
Předmět:
PERCENT OF TREATMENT EFFECT EXPLAINED
SURROGATE
Bone density
Endocrinology
Diabetes and Metabolism
medicine.medical_treatment
Medicina Clínica
law.invention
Placebos
Fractures
Bone
Absorptiometry
Photon
Randomized controlled trial
Bone Density
law
Monoclonal
purl.org/becyt/ford/3.2 [https]
80 and over
Medicine
Orthopedics and Sports Medicine
Humanized
Aged
80 and over
Bone mineral
Bone Density Conservation Agents
musculoskeletal
neural
and ocular physiology
Antibodies
Monoclonal
Middle Aged
musculoskeletal system
Photon
FRACTURE
bone mineral density
denosumab
Denosumab
Spinal Fractures
purl.org/becyt/ford/3 [https]
Female
Medicina Critica y de Emergencia
medicine.drug
musculoskeletal diseases
medicine.medical_specialty
CIENCIAS MÉDICAS Y DE LA SALUD
Bone pathology
Urology
Antibodies
Monoclonal
Humanized
Placebo
Antibodies
Double-Blind Method
Humans
Absorptiometry
Bone
Reduction (orthopedic surgery)
Aged
DENOSUMAB
business.industry
Original Articles
Surgery
business
Fractures
Risk Reduction Behavior
BONE MINERAL DENSITY
Zdroj: Journal of Bone and Mineral Research
CONICET Digital (CONICET)
Consejo Nacional de Investigaciones Científicas y Técnicas
instacron:CONICET
Journal of Bone and Mineral Research, vol 27, iss 3
ISSN: 1523-4681
0884-0431
Popis: Dual-energy X-ray absorptiometric bone mineral density (DXA BMD) is a strong predictor of fracture risk in untreated patients. However, previous patient-level studies suggest that BMD changes explain little of the fracture risk reduction observed with osteoporosis treatment. We investigated the relevance of DXA BMD changes as a predictor for fracture risk reduction using data from the FREEDOM trial, which randomly assigned placebo or denosumab 60 mg every 6 months to 7808 women aged 60 to 90 years with a spine or total hip BMD T-score < -2.5 and not < -4.0. We took a standard approach to estimate the percent of treatment effect explained using percent changes in BMD at a single visit (months 12, 24, or 36). We also applied a novel approach using estimated percent changes in BMD from baseline at the time of fracture occurrence (time-dependent models). Denosumab significantly increased total hip BMD by 3.2%, 4.4%, and 5.0% at 12, 24, and 36 months, respectively. Denosumab decreased the risk of new vertebral fractures by 68% (p < 0.0001) and nonvertebral fracture by 20% (p = 0.01) over 36 months. Regardless of the method used, the change in total hip BMD explained a considerable proportion of the effect of denosumab in reducing new or worsening vertebral fracture risk (35% [95% confidence interval (CI): 20%-61%] and 51% [95% CI: 39%-66%] accounted for by percent change at month 36 and change in time-dependent BMD, respectively) and explained a considerable amount of the reduction in nonvertebral fracture risk (87% [95% CI: 35% - >100%] and 72% [95% CI: 24% - >100%], respectively). Previous patient-level studies may have underestimated the strength of the relationship between BMD change and the effect of treatment on fracture risk or this relationship may be unique to denosumab. Copyright © 2012 American Society for Bone and Mineral Research. Fil: Austin, Matthew. Amgen Incorporated; Estados Unidos Fil: Yang, Yu Ching. Amgen Incorporated; Estados Unidos Fil: Vittinghoff, Eric. University of California; Estados Unidos Fil: Adami, Silvano. Universita di Verona; Italia Fil: Boonen, Steven. Katholikie Universiteit Leuven; Bélgica Fil: Bauer, Douglas C. University of California; Estados Unidos Fil: Bianchi, Gerolamo. Azienda Sanitaria Genovese; Italia Fil: Bolognese, Michael A.. Bethesda Health Research Center; Estados Unidos Fil: Christiansen, Claus Bohn. Center For Clinical And Basic Research As; Estados Unidos Fil: Eastell, Richard. University Of Sheffield; Reino Unido Fil: Grauer, Andreas. Amgen Incorporated; Estados Unidos Fil: Hawkins, Federico. Hospital Universitario 12 de Octubre; España Fil: Kendler, David L.. University of British Columbia; Canadá Fil: Oliveri, María Beatriz. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Medicina. Hospital de Clínicas General San Martín; Argentina Fil: McClung, Michael R.. Oregon Osteoporosis Center; Estados Unidos Fil: Reid, Ian R.. The University of Auckland; Nueva Zelanda Fil: Siris, Ethel S.. Columbia University; Estados Unidos Fil: Zanchetta, Jose. Universidad del Salvador; Argentina Fil: Zerbini, Cristiano A.F.. Centro Paulista de Investigação Clinica; Brasil Fil: Libanati, Cesar. Amgen Incorporated; Estados Unidos Fil: Cummings, Steven R.. University of California; Estados Unidos
Databáze: OpenAIRE
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