Circulating Myokine Levels and Bone Metabolism

Completed

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Drug: Teriparatide; Drug: Denosumab

• Registration Number: NCT04206618
• Lead Sponsor: 424 General Military Hospital

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...

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-20
• Primary Completion: 2020-09-30
• Study Completion: 2020-11-10
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

Substudy 1:

• adult women

Substudy 2:

• postmenopausal women with an incident hip fracture

Substudy 3:

• postmenopausal women with osteoporosis

Read More

Exclusion Criteria

• secondary osteoporosis
• any disease that could affect muscle and/or bone metabolism
• any medication that could affect muscle and/or bone metabolism

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
teriparatide group	Teriparatide	postmenopausal women with osteoporosis who will be treated with teriparatide (Forsteo) 1 injection of 20mcg subcutaneously daily for 12 months
denosumab group	Denosumab	postmenopausal women with osteoporosis who will be treated with denosumab (Prolia) 1 injection of 60mg subcutaneously every 6 months for 12 months

Primary Outcome Measures

Name	Time	Method
follistatin	0,3,12 months	circulating levels of myokine follistatin at baseline and their changes at 3 and 12 months with treatment

Secondary Outcome Measures

Name	Time	Method
activin-A	0,3,12 months	circulating levels of myokine activin-A at baseline and their changes at 3 and 12 months with treatment
FSTL3	0,3,12 months	circulating levels of myokine FSTL3 at baseline and their changes at 3 and 12 months with treatment
irisin	0,3,12 months	circulating levels of myokine irisin at baseline and their changes at 3 and 12 months with treatment
activin-B	0,3,12 months	circulating levels of activin-B at baseline and their changes at 3 and 12 months with treatment

Trial Locations

Locations (1)

424 General Military Hospital; 🇬🇷 Thessaloniki, Northern Greece, Greece