Denosumab After Teriparatide in Premenopausal Women With Idiopathic Osteoporosis.
bone density
bone turnover markers
denosumab
premenopausal osteoporosis
teriparatide
Journal
The Journal of clinical endocrinology and metabolism
ISSN: 1945-7197
Titre abrégé: J Clin Endocrinol Metab
Pays: United States
ID NLM: 0375362
Informations de publication
Date de publication:
24 03 2022
24 03 2022
Historique:
received:
10
09
2021
pubmed:
2
12
2021
medline:
16
4
2022
entrez:
1
12
2021
Statut:
ppublish
Résumé
We have previously reported that teriparatide is associated with substantial increases in bone mineral density (BMD) at the lumbar spine (LS), total hip (TH), and femoral neck (FN) and small declines at the distal radius in 41 premenopausal women with idiopathic osteoporosis (IOP), all severely affected with low trauma fractures and/or very low BMD. Effects of teriparatide dissipate if not followed by antiresorptives. To assess the effects of 12 and 24 months of denosumab in premenopausal women with IOP completing 24 months of teriparatide. This was a preplanned phase 2B extension study. Premenopausal women with IOP who had completed a course of teriparatide received denosumab 60 mg every 6 months over 24 months. The main outcome measure was within-group change in BMD at the LS at 12 months. Secondary outcomes include change in 12-month BMD at other sites, 24-month BMD at all sites, trabecular bone score (TBS), and bone turnover markers (BTMs). After completing teriparatide, 32 participants took denosumab for 12 months and 29 for 24 months, with statistically significant increases in BMD at the LS (5.2 ± 2.6% and 6.9 ± 2.6%), TH (2.9 ± 2.4% and 4.6 ± 2.8%), and FN (3.0 ± 3.8% and 4.7 ± 4.9%). Over the entire 24-month teriparatide and 24-month denosumab treatment period, BMD increased by 21.9 ± 7.8% at the LS, 9.8 ± 4.6% at the TH, and 9.5 ± 4.7% at the FN (all P < .0001). TBS increased by 5.8 ± 5.6% (P < .001). Serum BTM decreased by 75% to 85% by 3 months and remained suppressed through 12 months of denosumab. Denosumab was generally well tolerated. These data support the use of sequential teriparatide and denosumab to increase BMD in premenopausal women with severe osteoporosis.
Identifiants
pubmed: 34849989
pii: 6437931
doi: 10.1210/clinem/dgab850
pmc: PMC9122662
doi:
Substances chimiques
Bone Density Conservation Agents
0
Teriparatide
10T9CSU89I
Denosumab
4EQZ6YO2HI
Banques de données
ClinicalTrials.gov
['NCT02049866']
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
e1528-e1540Subventions
Organisme : FDA HHS
ID : R01 FD005114
Pays : United States
Organisme : FDA HHS
ID : R01 FD003902
Pays : United States
Organisme : NIAMS NIH HHS
ID : R03 AR064016
Pays : United States
Organisme : NIAMS NIH HHS
ID : K23 AR054127
Pays : United States
Organisme : NIAMS NIH HHS
ID : K24 AR052665
Pays : United States
Informations de copyright
© The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Références
Osteoporos Int. 2009 Dec;20(12):2095-104
pubmed: 19350340
Bone. 2015 Oct;79:259-66
pubmed: 26092650
J Clin Endocrinol Metab. 2006 Nov;91(11):4215-22
pubmed: 16940447
J Bone Miner Res. 2016 May;31(5):940-8
pubmed: 26498132
J Clin Endocrinol Metab. 2000 Sep;85(9):3069-76
pubmed: 10999788
J Clin Densitom. 2017 Oct - Dec;20(4):507-512
pubmed: 28624340
JBMR Plus. 2018 Jun 02;2(5):289-294
pubmed: 30283910
J Clin Endocrinol Metab. 2015 Nov;100(11):4208-14
pubmed: 26358172
N Engl J Med. 2001 May 10;344(19):1434-41
pubmed: 11346808
JAMA. 2016 Aug 16;316(7):715-6
pubmed: 27533154
Osteoporos Int. 2018 Feb;29(2):323-328
pubmed: 29167971
J Bone Miner Res. 2017 Oct;32(10):2001-2009
pubmed: 28608571
J Clin Endocrinol Metab. 2018 Aug 1;103(8):2949-2957
pubmed: 29800372
Osteoporos Int. 2016 May;27(5):1917-21
pubmed: 26694598
Bone. 2018 Nov;116:58-66
pubmed: 30021126
Bone. 2017 May;98:54-58
pubmed: 28286299
J Clin Endocrinol Metab. 2005 Jun;90(6):3331-6
pubmed: 15784712
J Womens Health (Larchmt). 2009 Jan-Feb;18(1):79-84
pubmed: 19132880
Lancet. 2013 Jul 6;382(9886):50-6
pubmed: 23683600
N Engl J Med. 2007 Nov 15;357(20):2028-39
pubmed: 18003959
Lancet. 2015 Sep 19;386(9999):1147-55
pubmed: 26144908
J Clin Densitom. 2011 Jul-Sep;14(3):302-12
pubmed: 21724435
JBMR Plus. 2018 Feb 27;2(2):62-68
pubmed: 30283892
Osteoporos Int. 2017 May;28(5):1723-1732
pubmed: 28144701
J Clin Endocrinol Metab. 2020 Oct 1;105(10):
pubmed: 32876328
Calcif Tissue Int. 2017 Oct;101(4):371-374
pubmed: 28500448
Osteoporos Int. 2012 Jan;23(1):171-82
pubmed: 21365462
J Clin Endocrinol Metab. 2014 Apr;99(4):1322-9
pubmed: 24456286
J Bone Miner Res. 2014 Mar;29(3):518-30
pubmed: 24443324
Arthritis Rheumatol. 2016 Sep;68(9):2122-8
pubmed: 27111239
Bone. 2015 Sep;78:216-24
pubmed: 25988660
J Bone Miner Res. 2018 Feb;33(2):188-189
pubmed: 29232486
Annu Rev Med. 2020 Jan 27;71:277-288
pubmed: 31509477
J Clin Invest. 2014 Feb;124(2):491-8
pubmed: 24463451
J Clin Densitom. 2019 Oct - Dec;22(4):501-505
pubmed: 31383412
JAMA. 1998 Sep 23-30;280(12):1067-73
pubmed: 9757854
J Clin Endocrinol Metab. 2013 May;98(5):1971-81
pubmed: 23543660
J Clin Endocrinol Metab. 2011 Oct;96(10):3095-105
pubmed: 21832117
Osteoporos Int. 2014 Jul;25(7):1945-51
pubmed: 24760244
Clin Endocrinol (Oxf). 2018 May;88(5):652-658
pubmed: 29389010
J Clin Endocrinol Metab. 2009 Nov;94(11):4351-60
pubmed: 19837923
J Clin Endocrinol Metab. 2012 Nov;97(11):4244-52
pubmed: 22962425
J Clin Endocrinol Metab. 2012 Sep;97(9):3161-9
pubmed: 22723310
Curr Opin Rheumatol. 2019 Jul;31(4):376-380
pubmed: 31090588
J Bone Miner Res. 2018 Jul;33(7):1219-1226
pubmed: 29573473