PMID- 34432114
OWN - NLM
STAT- MEDLINE
DCOM- 20220117
LR  - 20220117
IS  - 1433-2965 (Electronic)
IS  - 0937-941X (Linking)
VI  - 33
IP  - 1
DP  - 2022 Jan
TI  - Long-term persistence with denosumab: real-world data from the Austrian 
      Osteoporosis Clinic (AOC). A retrospective data analysis.
PG  - 263-272
LID - 10.1007/s00198-021-06102-2 [doi]
AB  - In short-term studies, persistence with denosumab has been higher than with other 
      osteoporosis drugs. This study shows that persistence can be maintained in the 
      long-term and is associated with efficacy and safety parameters. PURPOSE: To 
      assess long-term persistence with denosumab in postmenopausal women with 
      osteoporosis. Secondary purposes were the evaluation of changes in efficacy and 
      tolerance/safety parameters over time. METHODS: Persistence was determined by 
      number and rate of patients receiving denosumab on time in 6-month intervals 
      (+ / - 8 weeks). The total population was stratified by internal patients 
      (injections and monitoring at the Austrian Osteoporosis Clinic [AOC], 74%) and 
      external patients (injections at the practitioner's office with occasional 
      monitoring at the AOC, 26%). In internal patients, efficacy parameters including 
      bone mineral density (BMD) and the bone marker CTX were assessed at fixed time 
      points and tolerance/safety parameters including side effects (SEs), adverse 
      events (AEs), and serious AEs (SAEs) evaluated. RESULTS: Of 851 patients, 71% 
      (73% internal and 64% external) were persistent at 7.5 years of follow-up. The 
      mean rate of cumulative persistence in internal patients decreased from 94% at 
      the time of the second dose to 73% at the time of the fifteenth dose. BMD 
      increased and CTX decreased, overall and in pairwise comparisons (all p < .001). 
      AEs and SAEs, but not SEs, were lower in persistent than non-persistent patients. 
      CONCLUSIONS: This is the first study showing that long-term (> 3 years) 
      real-world persistence with denosumab could be maintained at a high level (> 70%) 
      in most patients. Denosumab was well tolerated and associated with decreased CTX 
      levels and increased BMD.
CI  - (c) 2021. International Osteoporosis Foundation and National Osteoporosis 
      Foundation.
FAU - Boschitsch, Ewald
AU  - Boschitsch E
AUID- ORCID: 0000-0002-9322-8826
AD  - Austrian Osteoporosis Clinic (AOC), Vienna, Austria. e.boschitsch@gmail.com.
AD  - KLIMAX Menopause and Osteoporosis Clinic, Vienna, Austria. 
      e.boschitsch@gmail.com.
FAU - Naegele, Oliver
AU  - Naegele O
AD  - KLIMAX Menopause and Osteoporosis Clinic, Vienna, Austria.
FAU - Klinger, Anita
AU  - Klinger A
AD  - Austrian Osteoporosis Clinic (AOC), Vienna, Austria.
AD  - KLIMAX Menopause and Osteoporosis Clinic, Vienna, Austria.
FAU - Brix-Samoylenko, Harald
AU  - Brix-Samoylenko H
AD  - Austrian Osteoporosis Clinic (AOC), Vienna, Austria.
LA  - eng
PT  - Journal Article
DEP - 20210825
PL  - England
TA  - Osteoporos Int
JT  - Osteoporosis international : a journal established as result of cooperation 
      between the European Foundation for Osteoporosis and the National Osteoporosis 
      Foundation of the USA
JID - 9100105
RN  - 0 (Bone Density Conservation Agents)
RN  - 4EQZ6YO2HI (Denosumab)
SB  - IM
MH  - Austria
MH  - Bone Density
MH  - *Bone Density Conservation Agents/adverse effects
MH  - Data Analysis
MH  - Denosumab/adverse effects
MH  - Female
MH  - Humans
MH  - Medication Adherence
MH  - *Osteoporosis/drug therapy
MH  - *Osteoporosis, Postmenopausal/drug therapy
MH  - Retrospective Studies
OTO - NOTNLM
OT  - Denosumab
OT  - Efficacy
OT  - Long-term persistence
OT  - Real-world data
OT  - Safety
OT  - Tolerance
EDAT- 2021/08/26 06:00
MHDA- 2022/01/18 06:00
CRDT- 2021/08/25 12:25
PHST- 2021/03/16 00:00 [received]
PHST- 2021/08/16 00:00 [accepted]
PHST- 2021/08/26 06:00 [pubmed]
PHST- 2022/01/18 06:00 [medline]
PHST- 2021/08/25 12:25 [entrez]
AID - 10.1007/s00198-021-06102-2 [pii]
AID - 10.1007/s00198-021-06102-2 [doi]
PST - ppublish
SO  - Osteoporos Int. 2022 Jan;33(1):263-272. doi: 10.1007/s00198-021-06102-2. Epub 
      2021 Aug 25.