PMID- 32258965
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210222
IS  - 2473-4039 (Electronic)
IS  - 2473-4039 (Linking)
VI  - 4
IP  - 4
DP  - 2020 Apr
TI  - Abaloparatide in Postmenopausal Women With Osteoporosis and Type 2 Diabetes: A 
      Post Hoc Analysis of the ACTIVE Study.
PG  - e10346
LID - 10.1002/jbm4.10346 [doi]
LID - e10346
AB  - Type 2 diabetes mellitus (T2DM) increases fracture risk despite normal or 
      increased BMD. Abaloparatide reduces fracture risk in patients with 
      postmenopausal osteoporosis (PMO); however, its efficacy in women with T2DM is 
      unknown. This post hoc analysis evaluated the efficacy and safety of 
      abaloparatide in patients with T2DM. The analysis included patients with T2DM 
      from the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE), a phase 
      3, double-blind, randomized, placebo- and active-controlled trial. In ACTIVE, 
      participants were randomized 1:1:1 to daily s.c. injections of placebo, 
      abaloparatide (80 mug), or open-label teriparatide (20 mug) for 18 months. A total 
      of 198 women with PMO and T2DM from 21 centers in 10 countries were identified 
      from ACTIVE through review of their medical records. The main outcomes measured 
      included effect of abaloparatide versus placebo on BMD and trabecular bone score 
      (TBS), with secondary outcomes of fracture risk and safety, in patients from 
      ACTIVE with T2DM. Significant (p < 0.001) improvements in BMD at total hip (mean 
      change 3.0% versus -0.4%), femoral neck (2.6% versus -0.2%), and lumbar spine 
      (8.9% versus 1.3%) and TBS at lumbar spine (3.72% versus -0.56%) were observed 
      with abaloparatide versus placebo at 18 months. Fracture events were fewer with 
      abaloparatide treatment in patients with T2DM, and differences were not 
      significant between groups except nonvertebral fractures in the abaloparatide 
      versus placebo groups (p = 0.04). Safety was consistent with the ACTIVE 
      population. In conclusion, in women with PMO and T2DM, abaloparatide treatment 
      resulted in significant improvements in BMD and TBS versus placebo, consistent 
      with the overall ACTIVE population (c) 2020 The Authors. JBMR Plus published by 
      Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral 
      Research.
CI  - (c) 2020 The Authors. JBMR Plus published by Wiley Periodicals, Inc. on behalf of 
      American Society for Bone and Mineral Research.
FAU - Dhaliwal, Ruban
AU  - Dhaliwal R
AUID- ORCID: 0000-0003-4179-4006
AD  - Metabolic Bone Disease Center State University of New York Upstate Medical 
      University Syracuse NY USA.
FAU - Hans, Didier
AU  - Hans D
AD  - Center of Bone Disease, Bones & Joints Department Lausanne University Hospital 
      Lausanne Switzerland.
FAU - Hattersley, Gary
AU  - Hattersley G
AD  - Clinical Development, Radius Health, Inc. Waltham MA USA.
FAU - Mitlak, Bruce
AU  - Mitlak B
AD  - Clinical Development, Radius Health, Inc. Waltham MA USA.
FAU - Fitzpatrick, Lorraine A
AU  - Fitzpatrick LA
AD  - Clinical Development, Radius Health, Inc. Waltham MA USA.
FAU - Wang, Yamei
AU  - Wang Y
AD  - Biostatistics, Radius Health, Inc. Waltham MA USA.
FAU - Schwartz, Ann V
AU  - Schwartz AV
AD  - Department of Epidemiology and Biostatistics UCSF School of Medicine San 
      Francisco CA USA.
FAU - Miller, Paul D
AU  - Miller PD
AD  - Research, Colorado Center for Bone Research Lakewood CO USA.
FAU - Josse, Robert G
AU  - Josse RG
AD  - Research, St. Michael's Hospital University of Toronto Toronto Canada.
LA  - eng
PT  - Journal Article
DEP - 20200227
PL  - England
TA  - JBMR Plus
JT  - JBMR plus
JID - 101707013
EIN - JBMR Plus. 2020 Nov 03;5(2):e10414. PMID: 33615100
PMC - PMC7117849
OTO - NOTNLM
OT  - ABALOPARATIDE
OT  - ANABOLICS
OT  - BONE MINERAL DENSITY
OT  - CLINICAL TRIALS
OT  - DXA
OT  - FRACTURE PREVENTION
OT  - OSTEOPOROSIS
OT  - TRABECULAR BONE SCORE
OT  - TYPE 2 DIABETES MELLITUS
EDAT- 2020/04/08 06:00
MHDA- 2020/04/08 06:01
PMCR- 2020/02/27
CRDT- 2020/04/08 06:00
PHST- 2019/07/19 00:00 [received]
PHST- 2020/01/15 00:00 [revised]
PHST- 2020/01/26 00:00 [accepted]
PHST- 2020/04/08 06:00 [entrez]
PHST- 2020/04/08 06:00 [pubmed]
PHST- 2020/04/08 06:01 [medline]
PHST- 2020/02/27 00:00 [pmc-release]
AID - JBM410346 [pii]
AID - 10.1002/jbm4.10346 [doi]
PST - epublish
SO  - JBMR Plus. 2020 Feb 27;4(4):e10346. doi: 10.1002/jbm4.10346. eCollection 2020 
      Apr.