PMID- 33631355
OWN - NLM
STAT- MEDLINE
DCOM- 20210708
LR  - 20210708
IS  - 1873-2763 (Electronic)
IS  - 1873-2763 (Linking)
VI  - 146
DP  - 2021 May
TI  - Denosumab versus alendronate in long-term glucocorticoid users: A 12-month 
      randomized controlled trial.
PG  - 115902
LID - S8756-3282(21)00064-8 [pii]
LID - 10.1016/j.bone.2021.115902 [doi]
AB  - OBJECTIVES: To compare the efficacy of denosumab and alendronate on raising spine 
      bone mineral density (BMD) in long-term glucocorticoid (GC) users. METHODS: Adult 
      patients receiving long-term prednisolone (>/=2.5 mg/day for >/=1 year) were 
      recruited and randomized to either subcutaneous denosumab (60 mg/6 months) or 
      oral alendronate (70 mg/week). BMD (lumbar spine, femoral neck, hip) and bone 
      markers (serum P1NP and CTX) were measured at month 0, 6 and 12. The difference 
      in spine BMD (primary outcome) at month 12 was compared between the two groups. 
      RESULTS: 139 subjects were recruited (age 50.0 +/- 12.7 years; 96% women): 69 
      assigned denosumab and 70 assigned alendronate. At entry, 73(53%) patients were 
      osteoporotic and 82(59%) patients were naive to the bisphosphonates. Baseline 
      clinical characteristics and BMD values were similar in the two groups. At month 
      12, a significant gain in mean BMD at the lumbar spine (+3.5 +/- 2.5%; p<0.001), 
      hip (+0.9 +/- 2.8%; p=0.01) and femoral neck (+1.04 +/- 4.1%; p=0.047); was observed 
      in denosumab-treated patients, whereas the corresponding change was +2.5 +/- 2.9% 
      (p<0.001), +1.6 +/- 2.7% (p<0.001) and + 1.5 +/- 3.9% (p=0.002) in the alendronate 
      group. The spine, but not the hip or femoral neck, BMD at month 12 was 
      significantly higher in the denosumab than alendronate group after adjustment for 
      baseline BMD values, age, sex, osteoporosis risk factors and the cumulative 
      prednisolone doses received in one year. The drop in P1NP and CTX was 
      significantly higher in the denosumab than alendronate group. Frequency of 
      adverse events (AEs), including infections, was similar in the two treatment 
      arms. Seven patients withdrew from the study but not related to AEs. CONCLUSIONS: 
      In patients receiving long-term GCs, denosumab is superior to alendronate in 
      raising the spine BMD after 12 months. Both drugs are well-tolerated.
CI  - Copyright (c) 2021 Elsevier Inc. All rights reserved.
FAU - Mok, Chi Chiu
AU  - Mok CC
AD  - Department of Medicine, Tuen Mun Hospital, Hong Kong. Electronic address: 
      ccmok2005@yahoo.com.
FAU - Ho, Ling Yin
AU  - Ho LY
AD  - Department of Medicine, Tuen Mun Hospital, Hong Kong.
FAU - Leung, Stella Mei Tik
AU  - Leung SMT
AD  - Department of Pathology, Queen Elizabeth Hospital, Tuen Mun Hospital, Hong Kong.
FAU - Cheung, Hoi Ning
AU  - Cheung HN
AD  - Department of Pathology, Queen Elizabeth Hospital, Tuen Mun Hospital, Hong Kong.
FAU - Chen, Sammy Pak Lam
AU  - Chen SPL
AD  - Department of Pathology, Queen Elizabeth Hospital, Tuen Mun Hospital, Hong Kong.
FAU - Ma, Kwok Man
AU  - Ma KM
AD  - Department of Nuclear Medicine, Tuen Mun Hospital, Hong Kong.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210223
PL  - United States
TA  - Bone
JT  - Bone
JID - 8504048
RN  - 0 (Bone Density Conservation Agents)
RN  - 0 (Glucocorticoids)
RN  - 4EQZ6YO2HI (Denosumab)
RN  - X1J18R4W8P (Alendronate)
SB  - IM
CIN - Bone. 2021 Jul;148:115947. PMID: 33845222
CIN - Bone. 2021 Jul;148:115948. PMID: 33864978
MH  - Adult
MH  - *Alendronate/therapeutic use
MH  - Bone Density
MH  - *Bone Density Conservation Agents/therapeutic use
MH  - Denosumab/adverse effects
MH  - Female
MH  - Glucocorticoids/adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
OTO - NOTNLM
OT  - Bisphosphonate
OT  - Corticosteroids
OT  - Denosumab
OT  - Fracture
OT  - Osteoporosis
EDAT- 2021/02/26 06:00
MHDA- 2021/07/09 06:00
CRDT- 2021/02/25 20:11
PHST- 2020/11/24 00:00 [received]
PHST- 2021/02/17 00:00 [revised]
PHST- 2021/02/19 00:00 [accepted]
PHST- 2021/02/26 06:00 [pubmed]
PHST- 2021/07/09 06:00 [medline]
PHST- 2021/02/25 20:11 [entrez]
AID - S8756-3282(21)00064-8 [pii]
AID - 10.1016/j.bone.2021.115902 [doi]
PST - ppublish
SO  - Bone. 2021 May;146:115902. doi: 10.1016/j.bone.2021.115902. Epub 2021 Feb 23.