Romosozumab efficacy and safety in European patients enrolled in the FRAME trial
Saved in:
| Title: | Romosozumab efficacy and safety in European patients enrolled in the FRAME trial |
|---|---|
| Authors: | Langdahl, Bente, Hofbauer, Lorenz C., Ferrari, Serge, Wang, Zhenxun, Fahrleitner-Pammer, Astrid, Gielen, Evelien, Lakatos, Peter, Czerwinski, Edward, Gimeno, Esteban Jodar, Timoshanko, Jen, Oates, Mary, Libanati, Cesar |
| Source: | Osteoporos Int Langdahl, B, Hofbauer, L C, Ferrari, S, Wang, Z, Fahrleitner-Pammer, A, Gielen, E, Lakatos, P, Czerwinski, E, Gimeno, E J, Timoshanko, J, Oates, M & Libanati, C 2022, 'Romosozumab efficacy and safety in European patients enrolled in the FRAME trial', Osteoporosis International, vol. 33, no. 12, pp. 2527-2536. https://doi.org/10.1007/s00198-022-06544-2 |
| Publisher Information: | Springer Science and Business Media LLC, 2022. |
| Publication Year: | 2022 |
| Subject Terms: | 0301 basic medicine, META-REGRESSION, FRACTURE RISK, 4202 Epidemiology, Bone Density Conservation Agents / adverse effects, OSTEOPOROSIS, 1117 Public Health and Health Services, 12. Responsible consumption, Osteoporotic Fractures/chemically induced, Endocrinology & Metabolism, 03 medical and health sciences, Clinical trials, 0302 clinical medicine, 0903 Biomedical Engineering, Double-Blind Method, Osteoporosis, Postmenopausal/complications, Bone Density, Humans, Bone Density Conservation Agents/adverse effects, Denosumab/adverse effects, Anabolics, Osteoporosis, Postmenopausal, Denosumab / adverse effects, Science & Technology, Bone Density Conservation Agents, Osteoporosis, Postmenopausal / complications, 3202 Clinical sciences, HIP FRACTURE, 1103 Clinical Sciences, 3. Good health, REDUCTION, POSTMENOPAUSAL WOMEN, Clinical fractures, Osteoporosis, Original Article, Female, Osteoporotic Fractures / chemically induced, BONE-MINERAL DENSITY, Denosumab, Life Sciences & Biomedicine, Osteoporotic Fractures |
| Description: | In this post hoc analysis, we assessed romosozumab efficacy and safety in European patients enrolled in FRAME. Romosozumab treatment through 12 months, followed by denosumab for a further 24 months, resulted in early and sustained risk reduction for major fracture categories, associated with large gains in bone mineral density.In the multinational FRAME phase 3 trial of romosozumab in postmenopausal women with osteoporosis, marked differences between clinical and non-vertebral fracture outcomes were observed among patients from Central and Southern America versus rest of world. This post hoc analysis assessed romosozumab efficacy and safety in European patients enrolled in the FRAME trial and extension study.In FRAME (NCT01575834), patients were randomised 1:1 to romosozumab 210 mg or placebo monthly (QM) for 12 months, followed by open-label denosumab 60 mg Q6M to month 36, including a 12-month extension study. We report incidence of major fracture outcomes, bone mineral density (BMD) change from baseline and safety for European patients enrolled in FRAME.In FRAME, 3013/7180 (41.96%) patients were European; 1494 received romosozumab and 1519 received placebo. Through 12 months, romosozumab reduced fracture risk versus placebo for non-vertebral fracture (1.4% versus 3.0%; p = 0.004), clinical fracture (1.4% versus 3.6%; p |
| Document Type: | Article Other literature type |
| File Description: | application/pdf |
| Language: | English |
| ISSN: | 1433-2965 0937-941X |
| DOI: | 10.1007/s00198-022-06544-2 |
| Access URL: | https://pubmed.ncbi.nlm.nih.gov/36173415 https://lirias.kuleuven.be/handle/20.500.12942/703647 https://doi.org/10.1007/s00198-022-06544-2 https://pure.au.dk/portal/en/publications/459a979d-5aea-42a7-bf02-f8da69a6d509 https://pure.au.dk/portal/en/publications/459a979d-5aea-42a7-bf02-f8da69a6d509 https://doi.org/10.1007/s00198-022-06544-2 https://pure.au.dk/ws/files/347114418/s00198-022-06544-2.pdf |
| Rights: | CC BY NC URL: http://creativecommons.org/licenses/by-nc/4.0/Open AccessThis 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/) . |
| Accession Number: | edsair.doi.dedup.....55487594fa2f4b17d27706ae03ea4422 |
| Database: | OpenAIRE |
Full Text Finder 
Nájsť tento článok vo Web of Science | Abstract: | In this post hoc analysis, we assessed romosozumab efficacy and safety in European patients enrolled in FRAME. Romosozumab treatment through 12 months, followed by denosumab for a further 24 months, resulted in early and sustained risk reduction for major fracture categories, associated with large gains in bone mineral density.In the multinational FRAME phase 3 trial of romosozumab in postmenopausal women with osteoporosis, marked differences between clinical and non-vertebral fracture outcomes were observed among patients from Central and Southern America versus rest of world. This post hoc analysis assessed romosozumab efficacy and safety in European patients enrolled in the FRAME trial and extension study.In FRAME (NCT01575834), patients were randomised 1:1 to romosozumab 210 mg or placebo monthly (QM) for 12 months, followed by open-label denosumab 60 mg Q6M to month 36, including a 12-month extension study. We report incidence of major fracture outcomes, bone mineral density (BMD) change from baseline and safety for European patients enrolled in FRAME.In FRAME, 3013/7180 (41.96%) patients were European; 1494 received romosozumab and 1519 received placebo. Through 12 months, romosozumab reduced fracture risk versus placebo for non-vertebral fracture (1.4% versus 3.0%; p = 0.004), clinical fracture (1.4% versus 3.6%; p |
|---|---|
| ISSN: | 14332965 0937941X |
| DOI: | 10.1007/s00198-022-06544-2 |