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Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials.
- Source :
-
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA [Osteoporos Int] 2024 Jul; Vol. 35 (7), pp. 1195-1204. Date of Electronic Publication: 2024 Apr 04. - Publication Year :
- 2024
-
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.<br />Purpose: Post hoc analysis evaluating efficacy and safety of romosozumab, administered in the immediate post‑fracture period, in the FRAME and ARCH phase 3 trials.<br />Methods: 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.<br />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 fracture‑related complications were reported in romosozumab-treated patients. BMD gains were numerically greater with romosozumab than comparators.<br />Conclusion: Data suggest support for the efficacy and safety of continuing romosozumab treatment following fracture.<br />Trial Registrations: NCT01575834; NCT01631214.<br /> (© 2024. The Author(s).)
- Subjects :
- Humans
Female
Aged
Middle Aged
Double-Blind Method
Bone Density drug effects
Aged, 80 and over
Drug Administration Schedule
Recurrence
Osteoporotic Fractures prevention & control
Bone Density Conservation Agents therapeutic use
Bone Density Conservation Agents adverse effects
Bone Density Conservation Agents administration & dosage
Spinal Fractures prevention & control
Spinal Fractures physiopathology
Osteoporosis, Postmenopausal drug therapy
Osteoporosis, Postmenopausal physiopathology
Osteoporosis, Postmenopausal complications
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal administration & dosage
Alendronate therapeutic use
Alendronate administration & dosage
Alendronate adverse effects
Denosumab therapeutic use
Denosumab adverse effects
Denosumab administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1433-2965
- Volume :
- 35
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA
- Publication Type :
- Academic Journal
- Accession number :
- 38573517
- Full Text :
- https://doi.org/10.1007/s00198-024-07049-w