Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials.
Osteoporos Int
; 35(7): 1195-1204, 2024 Jul.
Article
em En
| MEDLINE
| ID: mdl-38573517
ABSTRACT
Post hoc analysis of FRAME and ARCH revealed that on-study nonvertebral and vertebral fractures by Month 12 were less common in women initially treated with romosozumab versus placebo or alendronate. Recurrent fracture risk was also lower in romosozumabtreated patients, and there were no fracturerelated complications. Results support continuing romosozumab treatment postfracture. PURPOSE:
Post hoc analysis evaluating efficacy and safety of romosozumab, administered in the immediate postfracture period, in the FRAME and ARCH phase 3 trials.METHODS:
In FRAME (NCT01575834) and ARCH (NCT01631214), postmenopausal women with osteoporosis were randomized 11 to romosozumab 210 mg monthly or comparator (FRAME, placebo; ARCH, alendronate 70 mg weekly) for 12 months, followed by antiresorptive therapy (FRAME, denosumab; ARCH, alendronate). In patients who experienced on-study nonvertebral or new/worsening vertebral fracture by Month 12, we report the following fracture and treatmentemergent adverse event (TEAE) incidence through 36 months, bone mineral density changes (BMD), and romosozumab timing. Due to the sample sizes employed, meaningful statistical comparisons between treatments were not possible.RESULTS:
Incidence of on-study nonvertebral and vertebral fractures by Month 12 was numerically lower in romosozumab- versus comparator-treated patients (FRAME, 1.6% and 0.5% versus 2.1% and 1.6%; ARCH, 3.4% and 3.3% versus 4.6% and 4.9%, respectively). In those who experienced on-study nonvertebral fracture by Month 12, recurrent nonvertebral and subsequent vertebral fracture incidences were numerically lower in patients initially treated with romosozumab versus comparator (FRAME, 3.6% [2/56] and 1.8% [1/56] versus 9.2% [7/76] and 3.9% [3/76]; ARCH, 10.0% [7/70] and 5.7% [4/70] versus 12.6% [12/95] and 8.4% [8/95], respectively). Among those with on-study vertebral fracture by Month 12, recurrent vertebral and subsequent nonvertebral fracture incidences were numerically lower with romosozumab versus comparator (FRAME, 0.0% [0/17] and 0.0% [0/17] versus 11.9% [7/59] and 8.5% [5/59]; ARCH, 9.0% [6/67] and 7.5% [5/67] versus 15.0% [15/100] and 16.0% [16/100], respectively). In patients with fracture by Month 12, no fracturerelated complications were reported in romosozumab-treated patients. BMD gains were numerically greater with romosozumab than comparators.CONCLUSION:
Data suggest support for the efficacy and safety of continuing romosozumab treatment following fracture. TRIAL REGISTRATIONS NCT01575834; NCT01631214.Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Osteoporose Pós-Menopausa
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Fraturas da Coluna Vertebral
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Alendronato
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Conservadores da Densidade Óssea
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Fraturas por Osteoporose
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Denosumab
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Anticorpos Monoclonais
Limite:
Aged
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Aged80
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
Osteoporos Int
Assunto da revista:
METABOLISMO
/
ORTOPEDIA
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Estados Unidos