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OpenTrials
Completed

NCT Number: NCT04206618

Circulating Myokine Levels and Bone Metabolism

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

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Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

20 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

424 General Military Hospital

Thessaloniki, Northern Greece, 56429, Greece

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teriparatide

Drug

1 subcutaneous injection daily for 12 months

Other names: rhPTH 1-34

Denosumab

Drug

1 subcutaneous injection every 6 months for 12 months

Other names: RANKL inhibitor

Primary outcomes

  1. 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

  1. 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

  2. FSTL3

    Time frame: 0,3,12 months

    circulating levels of myokine FSTL3 at baseline and their changes at 3 and 12 months with treatment

  3. 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

  4. irisin

    Time frame: 0,3,12 months

    circulating levels of myokine irisin at baseline and their changes at 3 and 12 months with treatment

Sponsors and collaborators

Lead sponsor

424 General Military Hospital

Other

Collaborators

  • Beth Israel Deaconess Medical Center

Registry information

Official study title

The Role of Myokines in Postmenopausal Osteoporosis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 20, 2019
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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