NCT07519551

Brief Summary

This study aims to evaluate the relationship between serum myostatin and irisin levels and bone mineral density and muscle strength in postmenopausal women. Participants will be grouped according to bone mineral density as normal, osteopenic, or osteoporotic. Serum myostatin and irisin levels will be measured, and muscle strength will be assessed using handgrip strength and the five times sit-to-stand test. The associations between biochemical and functional parameters will be analyzed.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 2, 2026

Last Update Submit

April 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relationship between serum myostatin and irisin levels and bone mineral density (T-score)

    Serum myostatin and irisin levels will be measured from fasting venous blood samples, and bone mineral density will be assessed using dual-energy X-ray absorptiometry (DEXA). The relationship between these parameters will be evaluated.

    Baseline

Secondary Outcomes (2)

  • Relationship between serum myostatin and irisin levels and muscle strength

    Baseline

  • Comparison of serum myostatin and irisin levels among bone mineral density groups

    Baseline

Study Arms (3)

Normal BMD

Postmenopausal women with normal bone mineral density based on dual-energy X-ray absorptiometry (DEXA) T-scores.

Osteopenia

Postmenopausal women with osteopenia defined by dual-energy X-ray absorptiometry (DEXA) T-scores.

Osteoporosis

Postmenopausal women with osteoporosis defined by dual-energy X-ray absorptiometry (DEXA) T-scores.

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of postmenopausal women aged between 50 and 65 years who attend the outpatient clinic and meet the inclusion criteria. Participants will be classified into normal, osteopenic, and osteoporotic groups based on bone mineral density measurements obtained by dual-energy X-ray absorptiometry (DEXA).

You may qualify if:

  • Postmenopausal women aged between 50 and 65 years Availability of bone mineral density measurement by dual-energy X-ray absorptiometry (DEXA) Willingness to participate in the study

You may not qualify if:

  • Presence of malignancy Chronic kidney disease Chronic liver disease Neuromuscular disorders Recent major surgery or trauma Use of medications affecting bone or muscle metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples will be collected from participants after overnight fasting. Blood samples will be centrifuged to obtain serum, which will be used for the measurement of myostatin and irisin levels using appropriate laboratory methods. No genetic analysis will be performed, and samples will be used only for the purposes of this study.

MeSH Terms

Conditions

OsteoporosisBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Zeynep Karakuzu Güngör, M.D

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep Karakuzu Güngör, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 9, 2026

Study Start

April 3, 2026

Primary Completion

May 15, 2026

Study Completion

May 30, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04