DRUG
Teriparatide
1 subcutaneous injection daily for 12 months
Circulating Myokine Levels and Bone Metabolism
Status
Completed
Phase
Not applicable
Enrollment
220
Locations
1
Results
Not posted
Publications
11
Study summary
What the protocol is testing.
Circulating levels of several myokines will be measured in serum samples obtained from women in various categories of bone density and according to the presence of fracture or not as well as before and after treatment with teriparatide and denosumab
Full detailed description
Serum samples for the measurement of several myokines will be obtained from: 1) equal groups of premenopausal women with normal BMD, postmenopausal women with normal BMD, postmenopausal women with osteopenia, and postmenopausal women with osteoporosis; 2) women with hip fracture compared with controls (women subjected to surgery due to knee osteoathritis); 3) women with osteoporosis treated with teriparatide or denosumab for 12 months
Interventions
Treatment arms and agents.
DRUG
Denosumab
1 subcutaneous injection every 6 months for 12 months
Timeline
From registration to results.
First posted
Dec 20, 2019
Study start
Jun 1, 2019
Primary completion
Sep 30, 2020
Study completion
Nov 10, 2020
Results posted
Not reported
Registry updated
Jan 12, 2021
Outcomes
What the study measures.
Primary outcomes
follistatin
Time frame · 0,3,12 months
circulating levels of myokine follistatin at baseline and their changes at 3 and 12 months with treatment
Secondary outcomes
activin-A
Time frame · 0,3,12 months
circulating levels of myokine activin-A at baseline and their changes at 3 and 12 months with treatment
FSTL3
Time frame · 0,3,12 months
circulating levels of myokine FSTL3 at baseline and their changes at 3 and 12 months with treatment
activin-B
Time frame · 0,3,12 months
circulating levels of activin-B at baseline and their changes at 3 and 12 months with treatment
irisin
Time frame · 0,3,12 months
circulating levels of myokine irisin at baseline and their changes at 3 and 12 months with treatment
Eligibility
Who can take part.
- Minimum age
- 20 Years
- Maximum age
- 85 Years
- Sex
- FEMALE
- Healthy volunteers
- Yes
Inclusion Criteria: Substudy 1: • adult women Substudy 2: • postmenopausal women with an incident hip fracture Substudy 3: • postmenopausal women with osteoporosis Exclusion Criteria: * secondary osteoporosis * any disease that could affect muscle and/or bone metabolism * any medication that could affect muscle and/or bone metabolism
Study locations
1 registered sites.
Greece. Showing up to 24 locations stored in the fast local snapshot.
424 General Military Hospital
Thessaloniki, Northern Greece, Greece
Publications
Results and literature.
PMID 23178301 ↗Bowser M, Herberg S, Arounleut P, Shi X, Fulzele S, Hill WD, Isales CM, Hamrick MW. Effects of the activin A-myostatin-follistatin system on aging bone and muscle progenitor cells. Exp Gerontol. 2013 Feb;48(2):290-7. doi: 10.1016/j.exger.2012.11.004. Epub 2012 Nov 21.PMID 21787285 ↗Lotinun S, Pearsall RS, Horne WC, Baron R. Activin receptor signaling: a potential therapeutic target for osteoporosis. Curr Mol Pharmacol. 2012 Jun;5(2):195-204. doi: 10.2174/1874467211205020195.PMID 23124716 ↗Anastasilakis AD, Polyzos SA, Makras P, Gkiomisi A, Savvides M, Papatheodorou A, Terpos E. Circulating activin-A is elevated in postmenopausal women with low bone mass: the three-month effect of zoledronic acid treatment. Osteoporos Int. 2013 Jul;24(7):2127-32. doi: 10.1007/s00198-012-2198-0. Epub 2012 Nov 3.PMID 29499419 ↗Lodberg A, Eijken M, van der Eerden BCJ, Okkels MW, Thomsen JS, Bruel A. A soluble activin type IIA receptor mitigates the loss of femoral neck bone strength and cancellous bone mass in a mouse model of disuse osteopenia. Bone. 2018 May;110:326-334. doi: 10.1016/j.bone.2018.02.026. Epub 2018 Feb 28.PMID 20080223 ↗Lotinun S, Pearsall RS, Davies MV, Marvell TH, Monnell TE, Ucran J, Fajardo RJ, Kumar R, Underwood KW, Seehra J, Bouxsein ML, Baron R. A soluble activin receptor Type IIA fusion protein (ACE-011) increases bone mass via a dual anabolic-antiresorptive effect in Cynomolgus monkeys. Bone. 2010 Apr;46(4):1082-8. doi: 10.1016/j.bone.2010.01.370. Epub 2010 Jan 18.PMID 19049340 ↗Ruckle J, Jacobs M, Kramer W, Pearsall AE, Kumar R, Underwood KW, Seehra J, Yang Y, Condon CH, Sherman ML. Single-dose, randomized, double-blind, placebo-controlled study of ACE-011 (ActRIIA-IgG1) in postmenopausal women. J Bone Miner Res. 2009 Apr;24(4):744-52. doi: 10.1359/jbmr.081208.PMID 30881954 ↗Fahmy-Garcia S, Farrell E, Witte-Bouma J, Robbesom-van den Berge I, Suarez M, Mumcuoglu D, Walles H, Kluijtmans SGJM, van der Eerden BCJ, van Osch GJVM, van Leeuwen JPTM, van Driel M. Follistatin Effects in Migration, Vascularization, and Osteogenesis in vitro and Bone Repair in vivo. Front Bioeng Biotechnol. 2019 Mar 1;7:38. doi: 10.3389/fbioe.2019.00038. eCollection 2019.PMID 30759349 ↗Lodberg A, van der Eerden BCJ, Boers-Sijmons B, Thomsen JS, Bruel A, van Leeuwen JPTM, Eijken M. A follistatin-based molecule increases muscle and bone mass without affecting the red blood cell count in mice. FASEB J. 2019 May;33(5):6001-6010. doi: 10.1096/fj.201801969RR. Epub 2019 Feb 13.PMID 38976019 ↗Anastasilakis AD, Polyzos SA, Makras P, Savvidis M, Mantzoros CS. The comparative effect of teriparatide and denosumab on activins, follistatins, and inhibins in women with postmenopausal osteoporosis. J Bone Miner Res. 2024 Sep 2;39(9):1306-1314. doi: 10.1093/jbmr/zjae106.PMID 37221430 ↗Anastasilakis AD, Polyzos SA, Savvidis M, Anastasilakis DA, Sarridimitriou A, Kumar A, Kalra B, Makras P, Mantzoros CS. Association of activins, follistatins and inhibins with incident hip fracture in women with postmenopausal osteoporosis: a proof of concept, case-control study. Endocrine. 2023 Sep;81(3):573-578. doi: 10.1007/s12020-023-03402-x. Epub 2023 May 23.PMID 36587801 ↗Anastasilakis AD, Polyzos SA, Rodopaios NE, Makras P, Kumar A, Kalra B, Mantzoros CS. Activins, follistatins and inhibins in postmenopausal osteoporosis: A proof of concept, case-control study. Metabolism. 2023 Apr;141:155397. doi: 10.1016/j.metabol.2022.155397. Epub 2022 Dec 30.
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