Long-term consequences of osteoporosis therapy with denosumab

ABSTRACT Denosumab (DMAb) is a human monoclonal antibody used as an antiresorptive drug in the treatment of osteoporosis. Approval at a dosage of 60 mg every 6 months was based on the results of the randomized, placebo-controlled trial (FREEDOM). The design of this 3-year study included an extension...

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Main Authors: Francisco Bandeira, Lucian Batista de Oliveira, John P. Bilezikian
Format: Article
Language:English
Published: Brazilian Society of Endocrinology and Metabolism 2022-12-01
Series:Archives of Endocrinology and Metabolism
Subjects:
Online Access:http://www.scielo.br/scielo.php?script=sci_arttext&pid=S2359-39972022000500717&tlng=en
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author Francisco Bandeira
Lucian Batista de Oliveira
John P. Bilezikian
author_facet Francisco Bandeira
Lucian Batista de Oliveira
John P. Bilezikian
author_sort Francisco Bandeira
collection DOAJ
description ABSTRACT Denosumab (DMAb) is a human monoclonal antibody used as an antiresorptive drug in the treatment of osteoporosis. Approval at a dosage of 60 mg every 6 months was based on the results of the randomized, placebo-controlled trial (FREEDOM). The design of this 3-year study included an extension for up to 10 years. Those who were randomized to DMAb continued on drug, while those who were randomized to placebo transitioned to DMAb. The 10-year experience with DMAb provides data on efficacy of drug in terms of reduced fractures and continued increases in bone mineral density (BMD). The 10-year experience with denosumab also provides information about rare complications associated with the use of DMAb, such as osteonecrosis of the jaw (ONJ), and atypical femoral fractures (AFF). This experience provided new insights into the reversibility of effects upon discontinuation without follow-on therapy with another agent. This review focuses upon prolonged treatment with DMAb, with regard to beneficial effects on fracture reduction and safety. Additionally, its use in patients with impaired renal function, compare its results with those of bisphosphonates (BPs), the occurrence/frequency of complications, in addition to the use of different tools, from imaging techniques to histological findings, to evaluate its effects on bone tissue.
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spelling doaj.art-609b969c3ddf4b32bfbdbac357137b1c2022-12-22T04:21:21ZengBrazilian Society of Endocrinology and MetabolismArchives of Endocrinology and Metabolism2359-42922022-12-0166571772310.20945/2359-3997000000560Long-term consequences of osteoporosis therapy with denosumabFrancisco Bandeirahttps://orcid.org/0000-0003-0290-0742Lucian Batista de Oliveirahttps://orcid.org/0000-0002-6930-0664John P. Bilezikianhttps://orcid.org/0000-0002-1570-2617ABSTRACT Denosumab (DMAb) is a human monoclonal antibody used as an antiresorptive drug in the treatment of osteoporosis. Approval at a dosage of 60 mg every 6 months was based on the results of the randomized, placebo-controlled trial (FREEDOM). The design of this 3-year study included an extension for up to 10 years. Those who were randomized to DMAb continued on drug, while those who were randomized to placebo transitioned to DMAb. The 10-year experience with DMAb provides data on efficacy of drug in terms of reduced fractures and continued increases in bone mineral density (BMD). The 10-year experience with denosumab also provides information about rare complications associated with the use of DMAb, such as osteonecrosis of the jaw (ONJ), and atypical femoral fractures (AFF). This experience provided new insights into the reversibility of effects upon discontinuation without follow-on therapy with another agent. This review focuses upon prolonged treatment with DMAb, with regard to beneficial effects on fracture reduction and safety. Additionally, its use in patients with impaired renal function, compare its results with those of bisphosphonates (BPs), the occurrence/frequency of complications, in addition to the use of different tools, from imaging techniques to histological findings, to evaluate its effects on bone tissue.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S2359-39972022000500717&tlng=enDenosumabosteoporosisfracturesosteonecrosisbone remodeling
spellingShingle Francisco Bandeira
Lucian Batista de Oliveira
John P. Bilezikian
Long-term consequences of osteoporosis therapy with denosumab
Archives of Endocrinology and Metabolism
Denosumab
osteoporosis
fractures
osteonecrosis
bone remodeling
title Long-term consequences of osteoporosis therapy with denosumab
title_full Long-term consequences of osteoporosis therapy with denosumab
title_fullStr Long-term consequences of osteoporosis therapy with denosumab
title_full_unstemmed Long-term consequences of osteoporosis therapy with denosumab
title_short Long-term consequences of osteoporosis therapy with denosumab
title_sort long term consequences of osteoporosis therapy with denosumab
topic Denosumab
osteoporosis
fractures
osteonecrosis
bone remodeling
url http://www.scielo.br/scielo.php?script=sci_arttext&pid=S2359-39972022000500717&tlng=en
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