Testosterone therapy and bone quality in men with diabetes and hypogonadism: Study design and protocol.
Bone microarchitecture
Hypogonadism
Testosterone
Type 2 diabetes mellitus
Journal
Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157
Informations de publication
Date de publication:
Mar 2021
Mar 2021
Historique:
received:
18
05
2020
revised:
12
10
2020
accepted:
11
01
2021
entrez:
15
3
2021
pubmed:
16
3
2021
medline:
16
3
2021
Statut:
epublish
Résumé
Type 2 diabetes mellitus (T2D) is often accompanied by male hypogonadism and both conditions are associated with increased risk for fractures. Testosterone (T) has been shown to improve the bone health of hypogonadal men but has not been tested in patients who also have T2D in addition to low T. To date, there is no treatment that is specifically recommended for bone disease among patients with T2D. This study will evaluate the effect of T therapy on the bone health of male veterans with low T who also have T2D. This is a randomized double-blind placebo-controlled trial of 166 male veterans 35-65 years old, with T2D and hypogonadism, randomized to either T gel 1.62% or placebo for 12 months. We will evaluate the effect of T therapy on the following primary outcomes:1) changes in bone strength as measured by microfinite elements analysis (μFEA) using high-resolution peripheral quantitative computer tomography, 2) changes in bone turnover markers, and 3) changes in circulating osteoblast progenitors (COP) and osteoclast precursors cells. We anticipate that T therapy will result in improvement in bone strength owing to improvement in bone remodeling through an increase in osteoblastic differentiation and proliferation in patients with hypogonadism and T2D.
Identifiants
pubmed: 33718653
doi: 10.1016/j.conctc.2021.100723
pii: S2451-8654(21)00025-9
pmc: PMC7933702
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100723Subventions
Organisme : CSRD VA
ID : I01 CX001665
Pays : United States
Informations de copyright
© 2021 Published by Elsevier Inc.
Références
Bone. 2016 Nov;92:94-99
pubmed: 27535783
Bone. 2003 Oct;33(4):744-50
pubmed: 14555280
Endocrinology. 1989 Mar;124(3):1576-8
pubmed: 2521824
J Bone Miner Res. 2009 Mar;24(3):475-83
pubmed: 19049327
Osteoporos Int. 2014 Jun;25(6):1697-708
pubmed: 24676844
J Clin Endocrinol Metab. 2006 Sep;91(9):3404-10
pubmed: 16804043
Am J Med Sci. 1992 Jul;304(1):4-8
pubmed: 1642253
Diabetes Care. 2016 Jan;39(1):82-91
pubmed: 26622051
Diabetes. 1990 Apr;39(4):477-82
pubmed: 2180758
J Clin Endocrinol Metab. 2012 Sep;97(9):3240-50
pubmed: 22740707
J Endocr Soc. 2019 Jul 01;3(8):1617-1630
pubmed: 31403089
Bone Rep. 2016 Dec;5:181-185
pubmed: 27975078
J Bone Miner Res. 2010 Aug;25(8):1877-85
pubmed: 20200991
J Bone Miner Res. 2011 May;26(5):965-73
pubmed: 21541999
J Clin Endocrinol Metab. 2014 Jun;99(6):2155-63
pubmed: 24606073
Rev Sci Instrum. 2012 Apr;83(4):044301
pubmed: 22559552
N Engl J Med. 2006 Nov 9;355(19):2048-50
pubmed: 17093260
J Clin Endocrinol Metab. 2010 Nov;95(11):5045-55
pubmed: 20719835
J Bone Miner Res. 2014 Mar;29(3):570-80
pubmed: 23956027
Curr Opin Endocrinol Diabetes Obes. 2012 Dec;19(6):474-82
pubmed: 23076043
JAMA. 2006 Mar 15;295(11):1288-99
pubmed: 16537739
JAMA Intern Med. 2017 Apr 1;177(4):471-479
pubmed: 28241231
Curr Osteoporos Rep. 2013 Jun;11(2):156-62
pubmed: 23504495
Diabetes Care. 1999 May;22(5):818-22
pubmed: 10332688
J Clin Endocrinol Metab. 1996 Dec;81(12):4358-65
pubmed: 8954042
Diabetes Care. 2007 Apr;30(4):911-7
pubmed: 17392552
Int J Androl. 2002 Aug;25(4):195-201
pubmed: 12121568
J Bone Miner Res. 2006 Sep;21(9):1475-82
pubmed: 16939406
Clin Endocrinol (Oxf). 2001 Jun;54(6):739-50
pubmed: 11422108
J Clin Endocrinol Metab. 1999 Jun;84(6):1966-72
pubmed: 10372695
Med Eng Phys. 2001 Apr;23(3):165-73
pubmed: 11410381
Int J Androl. 2011 Dec;34(6 Pt 1):528-40
pubmed: 20969599
Curr Osteoporos Rep. 2013 Jun;11(2):136-46
pubmed: 23525967
J Med Device. 2013 Dec;7(4):410051-410056
pubmed: 24115973
J Bone Miner Res. 2017 Jun;32(6):1267-1273
pubmed: 28218468
Endocrinol Metab Clin North Am. 2014 Mar;43(1):233-43
pubmed: 24582100
J Clin Endocrinol Metab. 2010 Jun;95(6):2536-59
pubmed: 20525905
World J Exp Med. 2015 Aug 20;5(3):182-7
pubmed: 26309819
Front Endocrinol (Lausanne). 2020 May 15;11:277
pubmed: 32499757
J Bone Miner Res. 2014 Apr;29(4):787-95
pubmed: 24123088
Diabetes Care. 2000 Apr;23(4):490-4
pubmed: 10857940
Endocrine. 2019 Sep;65(3):692-706
pubmed: 31325085
Bone. 2017 Jun;99:14-19
pubmed: 28323146
J Clin Endocrinol Metab. 2005 Dec;90(12):6508-15
pubmed: 16189253
J Clin Endocrinol Metab. 2011 Jan;96(1):176-86
pubmed: 20881259
Ther Clin Risk Manag. 2009 Jun;5(3):427-48
pubmed: 19707253
J Bone Miner Res. 2005 Oct;20(10):1785-91
pubmed: 16160736
Diabetes Care. 2007 Jul;30(7):1860-1
pubmed: 17416787
Diabetes Care. 2008 Oct;31(10):2013-7
pubmed: 18650372
N Engl J Med. 2005 May 12;352(19):1959-66
pubmed: 15888696
J Bone Miner Res. 2014 Jan;29(1):1-23
pubmed: 23712442
J Clin Epidemiol. 1994 Nov;47(11):1245-51
pubmed: 7722560