Clinical trial NCT04206618: Circulating Myokine Levels and Bone Metabolism
Official title: The Role of Myokines in Postmenopausal Osteoporosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: 424 General Military Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2019-12-20
Enrollment: 220
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Substudy 1: equal groups (n=25) of premenopausal women with normal BMD, postmenopausal women with normal BMD, postmenopausal women with osteopenia, and postmenopausal women with osteoporosis Substudy 2: postmenopausal women with an incident hip fracture (n=40) compared with controls (postmenopausal women with knee osteoarhtritis) Substudy 3: postmenopausal women with osteoporosis will receive treatment with either teriparatide or denosumab for 12 months

Brief summary: 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

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

Eligibility criteria: 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

Primary outcomes:
measure: follistatin
timeFrame: 0,3,12 months
Secondary outcomes:
measure: activin-A
timeFrame: 0,3,12 months
measure: FSTL3
timeFrame: 0,3,12 months
measure: activin-B
timeFrame: 0,3,12 months
measure: irisin
timeFrame: 0,3,12 months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: 424 General Military Hospital
state: Northern Greece
Study officials:
affiliation: 424 General Military Hospital
name: Athanasios Anastasilakis, phD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.