PMID- 35654577
OWN - NLM
STAT- MEDLINE
DCOM- 20220711
LR  - 20221018
IS  - 2093-5978 (Electronic)
IS  - 2093-596X (Print)
IS  - 2093-596X (Linking)
VI  - 37
IP  - 3
DP  - 2022 Jun
TI  - Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A 
      Prospective, Observational Study in South Korea.
PG  - 497-505
LID - 10.3803/EnM.2022.1427 [doi]
AB  - BACKGRUOUND: The efficacy and safety of denosumab have been established in a 
      phase 3, randomized, placebo-controlled trial in Korean postmenopausal women with 
      osteoporosis. This postmarketing surveillance study was aimed to investigate the 
      safety and effectiveness of denosumab in Korean real-world clinical practice. 
      METHODS: Patients with osteoporosis who had received denosumab per the Korean 
      approved indications in the postmarketing setting between September 2014 and 
      September 2019 were enrolled. The primary endpoint was the incidence of adverse 
      events (AEs) and adverse drug reactions (ADRs). The secondary endpoint was the 
      percent change from baseline in bone mineral density (BMD) of the lumbar spine, 
      total hip, and femoral neck. RESULTS: Of the 3,221 patients enrolled, 3,185 were 
      included in the safety analysis set; 2,973 (93.3%) were female, and the mean+/- 
      standard deviation (SD) age was 68.9+/-9.9 years. The mean+/-SD study period was 
      350.0+/-71.4 days. AEs, fatal AEs, and ADRs occurred in 19.3%, 0.8%, and 1.6%, 
      respectively. The most frequent AEs, occurring in >0.5% of patients, were 
      dizziness (0.7%), arthralgia (0.7%), back pain (0.6%), and myalgia (0.6%). 
      Hypocalcemia occurred in 0.3% of patients. There were no cases of osteonecrosis 
      of the jaw and atypical femoral fracture. Mean+/-SD percent change from baseline in 
      BMD of the lumbar spine, total hip, and femoral neck was 7.3%+/-23.6%, 3.6%+/-31.4%, 
      and 3.2%+/-10.7%, respectively. CONCLUSION: The safety and effectiveness of 
      denosumab in Korean patients with osteoporosis in this study were comparable with 
      those in the Korean randomized controlled trial, with no new safety findings.
FAU - Rhee, Yumie
AU  - Rhee Y
AD  - Department of Internal Medicine, Severance Hospital, Endocrine Research 
      Institute, Yonsei University College of Medicine, Seoul, Korea.
FAU - Chang, Dong-Gune
AU  - Chang DG
AD  - Department of Orthopedic Surgery, Inje University Sanggye Paik Hospital, College 
      of Medicine, Inje University, Seoul, Korea.
FAU - Ha, Jeonghoon
AU  - Ha J
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul 
      St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 
      Seoul, Korea.
FAU - Kim, Sooa
AU  - Kim S
AD  - Amgen Korea Ltd., Seoul, Korea.
FAU - Lee, Yusun
AU  - Lee Y
AD  - Amgen Korea Ltd., Seoul, Korea.
FAU - Jo, Euna
AU  - Jo E
AD  - Amgen Korea Ltd., Seoul, Korea.
FAU - Koh, Jung-Min
AU  - Koh JM
AD  - Division of Endocrinology and Metabolism, Asan Medical Center, University of 
      Ulsan College of Medicine, Seoul, Korea.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Observational Study
PT  - Randomized Controlled Trial
DEP - 20220603
PL  - Korea (South)
TA  - Endocrinol Metab (Seoul)
JT  - Endocrinology and metabolism (Seoul, Korea)
JID - 101554139
RN  - 0 (Bone Density Conservation Agents)
RN  - 4EQZ6YO2HI (Denosumab)
SB  - IM
MH  - Aged
MH  - *Bone Density Conservation Agents/adverse effects
MH  - Denosumab/adverse effects
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Osteoporosis/chemically induced/drug therapy
MH  - *Osteoporosis, Postmenopausal/chemically induced/complications/drug therapy
MH  - Prospective Studies
PMC - PMC9262695
OTO - NOTNLM
OT  - Bone density
OT  - Denosumab
OT  - Korea
OT  - Osteoporosis
OT  - Postmarketing drug surveillance
OT  - Safety
COIS- CONFLICTS OF INTEREST Sooa Kim, YuSun Lee, and Euna Jo are employees of Amgen 
      Korea. This study was sponsored by Amgen Inc.
EDAT- 2022/06/03 06:00
MHDA- 2022/07/12 06:00
PMCR- 2022/06/01
CRDT- 2022/06/02 21:18
PHST- 2022/02/03 00:00 [received]
PHST- 2022/05/02 00:00 [accepted]
PHST- 2022/06/03 06:00 [pubmed]
PHST- 2022/07/12 06:00 [medline]
PHST- 2022/06/02 21:18 [entrez]
PHST- 2022/06/01 00:00 [pmc-release]
AID - EnM.2022.1427 [pii]
AID - enm-2022-1427 [pii]
AID - 10.3803/EnM.2022.1427 [doi]
PST - ppublish
SO  - Endocrinol Metab (Seoul). 2022 Jun;37(3):497-505. doi: 10.3803/EnM.2022.1427. 
      Epub 2022 Jun 3.