Circulating Myokine Levels and Bone Metabolism

Osteoporosis, Postmenopausal Clinical Trial

Official title:

The Role of Myokines in Postmenopausal Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206618
• Other study ID #: MYOBONE
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: November 10, 2020

Study information

• Verified date: January 2021
• Source: 424 General Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: November 10, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• Teriparatide
1 subcutaneous injection daily for 12 months
• Denosumab
1 subcutaneous injection every 6 months for 12 months

Locations

Country	Name	City	State
Greece	424 General Military Hospital	Thessaloniki	Northern Greece

Sponsors (2)

Lead Sponsor	Collaborator
424 General Military Hospital	Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

Greece, 

References & Publications (8)

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. — View Citation

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. — View 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. — View Citation

Lodberg A, Eijken M, van der Eerden BCJ, Okkels MW, Thomsen JS, Brüel 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. — View Citation

Lodberg A, van der Eerden BCJ, Boers-Sijmons B, Thomsen JS, Brüel 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	follistatin	circulating levels of myokine follistatin at baseline and their changes at 3 and 12 months with treatment	0,3,12 months
Secondary	activin-A	circulating levels of myokine activin-A at baseline and their changes at 3 and 12 months with treatment	0,3,12 months
Secondary	FSTL3	circulating levels of myokine FSTL3 at baseline and their changes at 3 and 12 months with treatment	0,3,12 months
Secondary	activin-B	circulating levels of activin-B at baseline and their changes at 3 and 12 months with treatment	0,3,12 months
Secondary	irisin	circulating levels of myokine irisin at baseline and their changes at 3 and 12 months with treatment	0,3,12 months