Effect of denosumab on bone mineral density in women receiving adjuvant aromatase inhibitors for non-metastatic breast cancer: subgroup analyses of a phase 3 study.
Breast Cancer Res Treat
; 118(1): 81-7, 2009 Nov.
Article
em En
| MEDLINE
| ID: mdl-19308727
ABSTRACT
Denosumab increased lumbar spine bone mineral density (BMD) versus placebo in a 2-year, randomized, placebo-controlled, phase 3 study of patients with hormone-receptor-positive, non-metastatic breast cancer and low bone mass who were receiving adjuvant aromatase inhibitor therapy. In subgroup analyses at 12 and 24 months, we evaluated factors (duration and type of aromatase inhibitor, tamoxifen use, age, time since menopause, body mass index, T-score) that might influence BMD at the lumbar spine, total hip, femoral neck, and 1/3 radius. Patients were randomized to receive placebo (n = 125) or 60 mg denosumab (n = 127) subcutaneously every 6 months. In all subgroups, 12 or 24 months' treatment with denosumab was associated with larger BMD gains than placebo across multiple skeletal sites. Most increases were statistically significant (P < 0.05). Twice-yearly administration of denosumab, regardless of patient subgroup or skeletal site, resulted in consistent increases in BMD versus placebo at 12 and 24 months.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Mama
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Densidade Óssea
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Osteoporose Pós-Menopausa
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Quimioterapia Adjuvante
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Inibidores da Aromatase
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Estrogênios
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Ligante RANK
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Anticorpos Monoclonais
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Neoplasias Hormônio-Dependentes
Tipo de estudo:
Clinical_trials
Limite:
Aged
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
Breast Cancer Res Treat
Ano de publicação:
2009
Tipo de documento:
Article
País de afiliação:
Estados Unidos