Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials
Uložené v:
| Názov: | Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials |
|---|---|
| Autori: | J. Lane, B. Langdahl, M. Stone, A. Kurth, M. Oates, J. Timoshanko, Z. Wang, C. Libanati, F. Cosman |
| Zdroj: | Osteoporos Int Lane, J, Langdahl, B, Stone, M, Kurth, A, Oates, M, Timoshanko, J, Wang, Z, Libanati, C & Cosman, F 2024, 'Romosozumab in patients who experienced an on-study fracture : post hoc analyses of the FRAME and ARCH phase 3 trials', Osteoporosis International, vol. 35, no. 7, pp. 1195-1204. https://doi.org/10.1007/s00198-024-07049-w |
| Informácie o vydavateľovi: | Springer Science and Business Media LLC, 2024. |
| Rok vydania: | 2024 |
| Predmety: | Aged, 80 and over, Bone Density Conservation Agents, Alendronate, Fracture risk, Antibodies, Monoclonal, Middle Aged, On-study fracture, Drug Administration Schedule, 3. Good health, 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, Osteoporosis, Postmenopausal/physiopathology [MeSH], Bone Density Conservation Agents/therapeutic use [MeSH], Antibodies, Monoclonal/administration, 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, 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], Aged |
| Popis: | 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. |
| Druh dokumentu: | Article Other literature type |
| Jazyk: | English |
| ISSN: | 1433-2965 0937-941X |
| DOI: | 10.1007/s00198-024-07049-w |
| Prístupová URL adresa: | https://pubmed.ncbi.nlm.nih.gov/38573517 https://repository.publisso.de/resource/frl:6517887 https://pure.au.dk/portal/en/publications/d5c2d2f1-6dd9-4508-8459-0e76fbe09ba4 http://www.scopus.com/inward/record.url?scp=85189426658&partnerID=8YFLogxK https://doi.org/10.1007/s00198-024-07049-w |
| Rights: | CC BY NC URL: http://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (http://creativecommons.org/licenses/by-nc/4.0/) . |
| Prístupové číslo: | edsair.doi.dedup.....bf06c25dcc05491d9442a7e247f38a32 |
| Databáza: | OpenAIRE |
Full Text Finder 
Nájsť tento článok vo Web of Science | Abstrakt: | 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. |
|---|---|
| ISSN: | 14332965 0937941X |
| DOI: | 10.1007/s00198-024-07049-w |