Osteoporosis, PostmenopausalNCT04206618
Circulating Myokine Levels and Bone Metabolism
An observational study of Osteoporosis, Postmenopausal, run by 424 General Military Hospital at 1 site in Greece.
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 Read more about this study
- Who is it for?
- Ages 20 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Teriparatide and Denosumab
- Type of treatment
- Injection or infusion
- How many people
- 220 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2019to 10 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Substudy 1:
- adult women
- Substudy 2:
- postmenopausal women with an incident hip fracture
- Substudy 3:
- postmenopausal women with osteoporosis
Who cannot join
- secondary osteoporosis
- any disease that could affect muscle and/or bone metabolism
- any medication that could affect muscle and/or bone metabolism
Trial locations and contacts
1 site in 1 country.
Greece1 site
424 General Military Hospital
Thessaloniki, Northern Greece, 56429
About this study
Official title: The Role of Myokines in Postmenopausal Osteoporosis
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
Read the 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
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Teriparatide, Denosumab
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called rhPTH 1-34
1 subcutaneous injection daily for 12 months
DenosumabDrug
Also called RANKL inhibitor
1 subcutaneous injection every 6 months for 12 months
| Study group | Role | What they receive |
|---|---|---|
| premenopausal normal | premenopausal women with normal BMD who will be subjected to a single morning, fasting blood drainage | |
| postmenopausal normal | postmenopausal women with normal BMD who will be subjected to a single morning, fasting blood drainage | |
| postmenopausal osteopenia | postmenopausal women with osteopenia who will be subjected to a single morning, fasting blood drainage | |
| postmenopausal osteoporosis | postmenopausal women with osteoporosis who will be subjected to a single morning, fasting blood drainage | |
| hip fracture | postmenopausal women at the moment of hip fracture who will be subjected to a single, fasting blood drainage right before osteosynthesis | |
| controls (knee osteoarthitis) | postmenopausal women with knee osteoarthritis who will be subjected to a single, fasting blood drainage right before arthroplasty and serve as controls | |
| teriparatide group | postmenopausal women with osteoporosis who will be treated with teriparatide (Forsteo) 1 injection of 20mcg subcutaneously daily for 12 months Receives: Drug: Teriparatide | |
| denosumab group | postmenopausal women with osteoporosis who will be treated with denosumab (Prolia) 1 injection of 60mg subcutaneously every 6 months for 12 months Receives: Drug: Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
follistatin
circulating levels of myokine follistatin at baseline and their changes at 3 and 12 months with treatment
Measured: 0,3,12 months
Secondary outcomes (4)
activin-A
circulating levels of myokine activin-A at baseline and their changes at 3 and 12 months with treatment
Measured: 0,3,12 months
FSTL3
circulating levels of myokine FSTL3 at baseline and their changes at 3 and 12 months with treatment
Measured: 0,3,12 months
activin-B
circulating levels of activin-B at baseline and their changes at 3 and 12 months with treatment
Measured: 0,3,12 months
irisin
circulating levels of myokine irisin at baseline and their changes at 3 and 12 months with treatment
Measured: 0,3,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Jun 2019
- Primary completion30 Sep 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- 424 General Military Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Athanasios D. Anastasilakis, 424 General Military Hospital
- Investigators
- Athanasios Anastasilakis, phD, Principal investigator, 424 General Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206618
- Sponsor's protocol ID
- MYOBONE
- Status last verified
- Jan 2021
- First submitted
- 18 Dec 2019
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will become available after study completion
Publications
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.
PubMed 23178301Lotinun 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.
PubMed 21787285Anastasilakis 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.
PubMed 23124716Lodberg 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.
PubMed 29499419Lotinun 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.
PubMed 20080223Ruckle 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.
PubMed 19049340Fahmy-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.
PubMed 30881954Lodberg 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.
PubMed 30759349Anastasilakis 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.
PubMed 38976019Anastasilakis 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.
PubMed 37221430Anastasilakis 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.
PubMed 36587801
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Myokines in Postmenopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT04206618
- Acronym / sponsor ID
- MYOBONE
- Conditions
- Osteoporosis, Postmenopausal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- 424 General Military HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| premenopausal normal | – | –premenopausal women with normal BMD who will be subjected to a single morning, fasting blood drainage |
| postmenopausal normal | – | –postmenopausal women with normal BMD who will be subjected to a single morning, fasting blood drainage |
| postmenopausal osteopenia | – | –postmenopausal women with osteopenia who will be subjected to a single morning, fasting blood drainage |
| postmenopausal osteoporosis | – | –postmenopausal women with osteoporosis who will be subjected to a single morning, fasting blood drainage |
| hip fracture | – | –postmenopausal women at the moment of hip fracture who will be subjected to a single, fasting blood drainage right before osteosynthesis |
| controls (knee osteoarthitis) | – | –postmenopausal women with knee osteoarthritis who will be subjected to a single, fasting blood drainage right before arthroplasty and serve as controls |
| teriparatide group | – | Drug: Teriparatidepostmenopausal women with osteoporosis who will be treated with teriparatide (Forsteo) 1 injection of 20mcg subcutaneously daily for 12 months |
| denosumab group | – | Drug: Denosumabpostmenopausal women with osteoporosis who will be treated with denosumab (Prolia) 1 injection of 60mg subcutaneously every 6 months for 12 months |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- adult women
- postmenopausal women with an incident hip fracture
- postmenopausal women with osteoporosis
Key exclusion criteria (3 listed)
- secondary osteoporosis
- any disease that could affect muscle and/or bone metabolism
- any medication that could affect muscle and/or bone metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeriparatideAlso: rhPTH 1-341 subcutaneous injection daily for 12 months | Drug | teriparatide group |
| DenosumabAlso: RANKL inhibitor1 subcutaneous injection every 6 months for 12 months | Drug | denosumab group |
Primary outcome
follistatin
Time frame: 0,3,12 months
circulating levels of myokine follistatin at baseline and their changes at 3 and 12 months with treatment
4 secondary outcomes
activin-A
Time frame: 0,3,12 months
FSTL3
Time frame: 0,3,12 months
activin-B
Time frame: 0,3,12 months
irisin
Time frame: 0,3,12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Background: PubMed 23178301Bowser 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.
- Background: PubMed 21787285Lotinun 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.
- Background: PubMed 23124716Anastasilakis 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.
- Background: PubMed 29499419Lodberg 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.
- Background: PubMed 20080223Lotinun 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.
- Background: PubMed 19049340Ruckle 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.
- Background: PubMed 30881954Fahmy-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.
- Background: PubMed 30759349Lodberg 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.
- Derived from this study: PubMed 38976019Anastasilakis 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.
- Derived from this study: PubMed 37221430Anastasilakis 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.
- Derived from this study: PubMed 36587801Anastasilakis 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.
- Individual participant dataSharing planned: Undecided. Data will become available after study completion
Related trials for Osteoporosis, Postmenopausal
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Active, not recruitingPhase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Osteoporosis, Postmenopausal
RecruitingPhase 4
Combined Anabolic Therapy
Osteoporosis, Postmenopausal, Osteoporosis
Recruiting
Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis
Post Menopausal Osteoporosis
Not yet recruitingPhase 2
Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass
Postmenopausal Osteoporosis, Low Bone Mass
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanasios Anastasilakis, phD principal investigator
424 General Military Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Postmenopausal, run by 424 General Military Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
follistatin (time frame: 0,3,12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04206618, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.