Circulating Myokine Levels and Bone Metabolism

January 11, 2021 updated by: Athanasios D. Anastasilakis, 424 General Military Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Northern Greece
      • Thessaloniki, Northern Greece, Greece, 56429
        • 424 General Military Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Drug: Teriparatide
1 subcutaneous injection daily for 12 months
Other Names:
  • rhPTH 1-34
denosumab group
postmenopausal women with osteoporosis who will be treated with denosumab (Prolia) 1 injection of 60mg subcutaneously every 6 months for 12 months
Drug: Denosumab
1 subcutaneous injection every 6 months for 12 months
Other Names:
  • RANKL inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
follistatin
Time Frame: 0,3,12 months
circulating levels of myokine follistatin at baseline and their changes at 3 and 12 months with treatment
0,3,12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0,3,12 months
FSTL3
Time Frame: 0,3,12 months
circulating levels of myokine FSTL3 at baseline and their changes at 3 and 12 months with treatment
0,3,12 months
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
0,3,12 months
irisin
Time Frame: 0,3,12 months
circulating levels of myokine irisin at baseline and their changes at 3 and 12 months with treatment
0,3,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

424 General Military Hospital

Collaborators

Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Athanasios Anastasilakis, phD, 424 General Military Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

November 10, 2020

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYOBONE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will become available after study completion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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