KLI

Romosozumab in Postmenopausal Korean Women with Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study

Metadata Downloads
Abstract
Background: This phase 3 study evaluated the efficacy and safety of 6-month treatment with romosozumab in Korean postmenopausal women with osteoporosis.

Methods: Sixty-seven postmenopausal women with osteoporosis (bone mineral density [BMD] T-scores <=-2.5 at the lumbar spine, total hip, or femoral neck) were randomized (1:1) to receive monthly subcutaneous injections of romosozumab (210 mg; n=34) or placebo (n=33) for 6 months.

Results: At month 6, the difference in the least square (LS) mean percent change from baseline in lumbar spine BMD (primary efficacy endpoint) between the romosozumab (9.5%) and placebo (-0.1%) groups was significant (9.6%; 95% confidence interval, 7.6 to 11.5; P<0.001). The difference in the LS mean percent change from baseline was also significant for total hip and femoral neck BMD (secondary efficacy endpoints). After treatment with romosozumab, the percent change from baseline in procollagen type 1 N-terminal propeptide transiently increased at months 1 and 3, while that in C-terminal telopeptide of type 1 collagen showed a sustained decrease. No events of cancer, hypocalcemia, injection site reaction, positively adjudicated atypical femoral fracture or osteonecrosis of the jaw, or positively adjudicated serious cardiovascular adverse events were observed. At month 9, 17.6% and 2.9% of patients in the romosozumab group developed binding and neutralizing antibodies, respectively.

Conclusion: Treatment with romosozumab for 6 months was well tolerated and significantly increased lumbar spine, total hip, and femoral neck BMD compared with placebo in Korean postmenopausal women with osteoporosis
Author(s)
고정민김경민김인주민용기백기현정윤석Hyungjin ChoJudy MaddoxKi Deok ParkRajani DinavahiSang Jin LeeSooa KimSung-Kil LimWenjing Yang
Issued Date
2021
Type
Article
Keyword
Bone densityBone turnover markersKoreaOriginalRandomized controlled trialRomosozumab내과학
DOI
10.3803/EnM.2020.848
URI
https://oak.ulsan.ac.kr/handle/2021.oak/7810
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_nrf_kci_oai_kci_go_kr_ARTI_9747839&amp;context=PC&amp;vid=ULSAN&amp;lang=ko_KR&amp;search_scope=default_scope&amp;adaptor=primo_central_multiple_fe&amp;tab=default_tab&amp;query=any,contains,Romosozumab%20in%20Postmenopausal%20Korean%20Women%20with%20Osteoporosis:%20A%20Randomized,%20Double-Blind,%20Placebo-Controlled%20Efficacy%20and%20Safety%20Study&amp;offset=0&amp;pcAvailability=true
Publisher
ENDOCRINOLOGY AND METABOLISM
Location
대한민국
Language
영어
ISSN
2093-596X
Citation Volume
36
Citation Number
1
Citation Start Page
60
Citation End Page
69
Appears in Collections:
Medicine > Medicine
Authorize & License
  • Authorize공개
Files in This Item:
  • There are no files associated with this item.

Items in Repository are protected by copyright, with all rights reserved, unless otherwise indicated.