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Osteoporosis International
Article . 2024 . Peer-reviewed
License: CC BY NC
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Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials

Authors: J. Lane; B. Langdahl; M. Stone; A. Kurth; M. Oates; J. Timoshanko; Z. Wang; +2 Authors

Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials

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 romosozumab‑treated patients, and there were no fracture‑related complications. Results support continuing romosozumab treatment post‑fracture.Post hoc analysis evaluating efficacy and safety of romosozumab, administered in the immediate post‑fracture period, in the FRAME and ARCH phase 3 trials.In FRAME (NCT01575834) and ARCH (NCT01631214), postmenopausal women with osteoporosis were randomized 1:1 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 treatment‑emergent 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.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 fracture‑related complications were reported in romosozumab-treated patients. BMD gains were numerically greater with romosozumab than comparators.Data suggest support for the efficacy and safety of continuing romosozumab treatment following fracture.NCT01575834; NCT01631214.

Keywords

Aged, 80 and over, Bone Density Conservation Agents, Alendronate, Fracture risk, Antibodies, Monoclonal, Middle Aged, On-study fracture, Drug Administration Schedule, Double-Blind Method, Bone Density, Recurrence, Romosozumab, Bone mineral density, Osteoporosis, Humans, Spinal Fractures, Original Article, Female, Denosumab, Osteoporotic Fractures, Osteoporosis, Postmenopausal, Double-Blind Method [MeSH] ; Aged, 80 and over [MeSH] ; Aged [MeSH] ; Antibodies, Monoclonal/therapeutic use [MeSH] ; Osteoporosis, Postmenopausal/complications [MeSH] ; Alendronate/adverse effects [MeSH] ; Osteoporosis, Postmenopausal/drug therapy [MeSH] ; Alendronate/administration ; Fracture risk ; Osteoporosis, Postmenopausal/physiopathology [MeSH] ; Original Article ; Bone Density Conservation Agents/therapeutic use [MeSH] ; Antibodies, Monoclonal/administration ; Bone mineral density ; Alendronate/therapeutic use [MeSH] ; Female [MeSH] ; Bone Density Conservation Agents/administration ; Bone Density/drug effects [MeSH] ; Humans [MeSH] ; Spinal Fractures/physiopathology [MeSH] ; Spinal Fractures/prevention ; Drug Administration Schedule [MeSH] ; Middle Aged [MeSH] ; Denosumab/administration ; On-study fracture ; Osteoporosis ; Osteoporotic Fractures/prevention ; Denosumab/therapeutic use [MeSH] ; Recurrence [MeSH] ; Bone Density Conservation Agents/adverse effects [MeSH] ; Denosumab/adverse effects [MeSH] ; Antibodies, Monoclonal/adverse effects [MeSH] ; Romosozumab, Aged

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
4
Top 10%
Average
Average
Green
hybrid
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