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Once-Weekly Injection of Low-Dose Teriparatide (28.2 μg) Reduced the Risk of Vertebral Fracture in Patients with Primary Osteoporosis

We conducted a randomized, double-blind trial to assess the effect of 28.2 μg teriparatide versus placebo (1.4 μg teriparatide) on reduction of the incidence of vertebral fractures. Individuals enrolled in this study included patients with primary osteoporosis with one to five vertebral fractures an...

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Autores principales: Fujita, Takuo, Fukunaga, Masao, Itabashi, Akira, Tsutani, Kiichiro, Nakamura, Toshitaka
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3899450/
https://www.ncbi.nlm.nih.gov/pubmed/23963633
http://dx.doi.org/10.1007/s00223-013-9777-8
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author Fujita, Takuo
Fukunaga, Masao
Itabashi, Akira
Tsutani, Kiichiro
Nakamura, Toshitaka
author_facet Fujita, Takuo
Fukunaga, Masao
Itabashi, Akira
Tsutani, Kiichiro
Nakamura, Toshitaka
author_sort Fujita, Takuo
collection PubMed
description We conducted a randomized, double-blind trial to assess the effect of 28.2 μg teriparatide versus placebo (1.4 μg teriparatide) on reduction of the incidence of vertebral fractures. Individuals enrolled in this study included patients with primary osteoporosis with one to five vertebral fractures and capable of self-supported walking. Attention was focused on incident vertebral fractures, change in bone mineral density (BMD) of the lumbar spine, and safety. A total of 316 subjects participated in the study, which lasted up to 131 weeks. Incident vertebral fractures occurred in 3.3 % of subjects in the 28.2 μg teriparatide-treated group and 12.6 % of subjects in the placebo group during the 78-weeks study period. Kaplan–Meier estimates of risk after 78 weeks were 7.5 and 22.2 % in the teriparatide and placebo groups, respectively, with a relative risk reduction of 66.4 % by teriparatide (P = 0.008). Lumbar BMD in the 28.2 μg teriparatide group increased significantly by 4.4 ± 4.7 % at 78 weeks, which was significantly higher than the corresponding data in the placebo group (P = 0.001). Adverse events were observed in 86.7 % of individuals in the teriparatide group and 86.1 % of those in the placebo group. In conclusion, weekly injection of a low-dose of teriparatide (28.2 μg) reduced the risk of incident vertebral fractures and increased lumbar BMD.
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spelling pubmed-38994502014-01-29 Once-Weekly Injection of Low-Dose Teriparatide (28.2 μg) Reduced the Risk of Vertebral Fracture in Patients with Primary Osteoporosis Fujita, Takuo Fukunaga, Masao Itabashi, Akira Tsutani, Kiichiro Nakamura, Toshitaka Calcif Tissue Int Original Research We conducted a randomized, double-blind trial to assess the effect of 28.2 μg teriparatide versus placebo (1.4 μg teriparatide) on reduction of the incidence of vertebral fractures. Individuals enrolled in this study included patients with primary osteoporosis with one to five vertebral fractures and capable of self-supported walking. Attention was focused on incident vertebral fractures, change in bone mineral density (BMD) of the lumbar spine, and safety. A total of 316 subjects participated in the study, which lasted up to 131 weeks. Incident vertebral fractures occurred in 3.3 % of subjects in the 28.2 μg teriparatide-treated group and 12.6 % of subjects in the placebo group during the 78-weeks study period. Kaplan–Meier estimates of risk after 78 weeks were 7.5 and 22.2 % in the teriparatide and placebo groups, respectively, with a relative risk reduction of 66.4 % by teriparatide (P = 0.008). Lumbar BMD in the 28.2 μg teriparatide group increased significantly by 4.4 ± 4.7 % at 78 weeks, which was significantly higher than the corresponding data in the placebo group (P = 0.001). Adverse events were observed in 86.7 % of individuals in the teriparatide group and 86.1 % of those in the placebo group. In conclusion, weekly injection of a low-dose of teriparatide (28.2 μg) reduced the risk of incident vertebral fractures and increased lumbar BMD. Springer US 2013-08-21 2014 /pmc/articles/PMC3899450/ /pubmed/23963633 http://dx.doi.org/10.1007/s00223-013-9777-8 Text en © The Author(s) 2013 https://creativecommons.org/licenses/by/2.0/ Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Research
Fujita, Takuo
Fukunaga, Masao
Itabashi, Akira
Tsutani, Kiichiro
Nakamura, Toshitaka
Once-Weekly Injection of Low-Dose Teriparatide (28.2 μg) Reduced the Risk of Vertebral Fracture in Patients with Primary Osteoporosis
title Once-Weekly Injection of Low-Dose Teriparatide (28.2 μg) Reduced the Risk of Vertebral Fracture in Patients with Primary Osteoporosis
title_full Once-Weekly Injection of Low-Dose Teriparatide (28.2 μg) Reduced the Risk of Vertebral Fracture in Patients with Primary Osteoporosis
title_fullStr Once-Weekly Injection of Low-Dose Teriparatide (28.2 μg) Reduced the Risk of Vertebral Fracture in Patients with Primary Osteoporosis
title_full_unstemmed Once-Weekly Injection of Low-Dose Teriparatide (28.2 μg) Reduced the Risk of Vertebral Fracture in Patients with Primary Osteoporosis
title_short Once-Weekly Injection of Low-Dose Teriparatide (28.2 μg) Reduced the Risk of Vertebral Fracture in Patients with Primary Osteoporosis
title_sort once-weekly injection of low-dose teriparatide (28.2 μg) reduced the risk of vertebral fracture in patients with primary osteoporosis
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3899450/
https://www.ncbi.nlm.nih.gov/pubmed/23963633
http://dx.doi.org/10.1007/s00223-013-9777-8
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