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Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab

SUMMARY: Romosozumab is a therapy that stimulates bone formation and reduces bone resorption. In this study of postmenopausal women with low BMD, a second course of romosozumab following a period off treatment or on denosumab increased or maintained BMD, respectively, and was well tolerated, providi...

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Autores principales: Kendler, D.L., Bone, H.G., Massari, F., Gielen, E., Palacios, S., Maddox, J., Yan, C., Yue, S., Dinavahi, R.V., Libanati, C., Grauer, A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer London 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6877701/
https://www.ncbi.nlm.nih.gov/pubmed/31628490
http://dx.doi.org/10.1007/s00198-019-05146-9
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author Kendler, D.L.
Bone, H.G.
Massari, F.
Gielen, E.
Palacios, S.
Maddox, J.
Yan, C.
Yue, S.
Dinavahi, R.V.
Libanati, C.
Grauer, A.
author_facet Kendler, D.L.
Bone, H.G.
Massari, F.
Gielen, E.
Palacios, S.
Maddox, J.
Yan, C.
Yue, S.
Dinavahi, R.V.
Libanati, C.
Grauer, A.
author_sort Kendler, D.L.
collection PubMed
description SUMMARY: Romosozumab is a therapy that stimulates bone formation and reduces bone resorption. In this study of postmenopausal women with low BMD, a second course of romosozumab following a period off treatment or on denosumab increased or maintained BMD, respectively, and was well tolerated, providing insight into treatment sequence options. INTRODUCTION: In patients with high fracture risk, therapies that stimulate bone formation provide rapid BMD gains; currently available agents, parathyroid hormone receptor agonists, are limited to a 2-year lifetime exposure and generally used for a single treatment course. However, for long-term osteoporosis management, a second treatment course may be appropriate. Romosozumab, a therapy with the dual effect of increasing bone formation and decreasing bone resorption, reduces fracture risk within 12 months. Here, we report efficacy and safety of a second romosozumab course. METHODS: In this phase 2, dose-finding study, postmenopausal women with low bone mass (T-score ≤ − 2.0 and ≥ − 3.5) received romosozumab or placebo (month 0–24) followed by placebo or denosumab (month 24–36); participants then received a year of romosozumab (month 36–48). RESULTS: Of 167 participants who entered the month 36–48 period, 35 had been initially randomized to romosozumab 210 mg monthly. In participants who received romosozumab 210 mg monthly followed by placebo, a second romosozumab course (n = 19) increased BMD by amounts similar to their initial treatment (month 0–12) at the lumbar spine (12.4%; 12.0%, respectively) and total hip (6.0%; 5.5%, respectively). Following denosumab, a second romosozumab course (n = 16) increased BMD at the lumbar spine (2.3%) and maintained BMD at the total hip. Safety profiles were similar between first and second romosozumab courses. CONCLUSIONS: After 12 months off-treatment, a second romosozumab course again led to rapid and large BMD gains. Following denosumab, BMD gains with romosozumab were smaller than with initial treatment. No new safety findings were observed during the second course. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00198-019-05146-9) contains supplementary material, which is available to authorized users.
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spelling pubmed-68777012019-12-10 Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab Kendler, D.L. Bone, H.G. Massari, F. Gielen, E. Palacios, S. Maddox, J. Yan, C. Yue, S. Dinavahi, R.V. Libanati, C. Grauer, A. Osteoporos Int Original Article SUMMARY: Romosozumab is a therapy that stimulates bone formation and reduces bone resorption. In this study of postmenopausal women with low BMD, a second course of romosozumab following a period off treatment or on denosumab increased or maintained BMD, respectively, and was well tolerated, providing insight into treatment sequence options. INTRODUCTION: In patients with high fracture risk, therapies that stimulate bone formation provide rapid BMD gains; currently available agents, parathyroid hormone receptor agonists, are limited to a 2-year lifetime exposure and generally used for a single treatment course. However, for long-term osteoporosis management, a second treatment course may be appropriate. Romosozumab, a therapy with the dual effect of increasing bone formation and decreasing bone resorption, reduces fracture risk within 12 months. Here, we report efficacy and safety of a second romosozumab course. METHODS: In this phase 2, dose-finding study, postmenopausal women with low bone mass (T-score ≤ − 2.0 and ≥ − 3.5) received romosozumab or placebo (month 0–24) followed by placebo or denosumab (month 24–36); participants then received a year of romosozumab (month 36–48). RESULTS: Of 167 participants who entered the month 36–48 period, 35 had been initially randomized to romosozumab 210 mg monthly. In participants who received romosozumab 210 mg monthly followed by placebo, a second romosozumab course (n = 19) increased BMD by amounts similar to their initial treatment (month 0–12) at the lumbar spine (12.4%; 12.0%, respectively) and total hip (6.0%; 5.5%, respectively). Following denosumab, a second romosozumab course (n = 16) increased BMD at the lumbar spine (2.3%) and maintained BMD at the total hip. Safety profiles were similar between first and second romosozumab courses. CONCLUSIONS: After 12 months off-treatment, a second romosozumab course again led to rapid and large BMD gains. Following denosumab, BMD gains with romosozumab were smaller than with initial treatment. No new safety findings were observed during the second course. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00198-019-05146-9) contains supplementary material, which is available to authorized users. Springer London 2019-10-18 2019 /pmc/articles/PMC6877701/ /pubmed/31628490 http://dx.doi.org/10.1007/s00198-019-05146-9 Text en © The Author(s) 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Article
Kendler, D.L.
Bone, H.G.
Massari, F.
Gielen, E.
Palacios, S.
Maddox, J.
Yan, C.
Yue, S.
Dinavahi, R.V.
Libanati, C.
Grauer, A.
Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab
title Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab
title_full Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab
title_fullStr Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab
title_full_unstemmed Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab
title_short Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab
title_sort bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6877701/
https://www.ncbi.nlm.nih.gov/pubmed/31628490
http://dx.doi.org/10.1007/s00198-019-05146-9
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