NCT07045012

Brief Summary

This cross-sectional study will include postmenopausal women under the age of 60 who visited the Physical Medicine and Rehabilitation outpatient clinic at Beylikdüzü State Hospital between June 25 and July 25, 2025. Participants must have undergone a bone mineral density (BMD) assessment within the past six months using Dual X-ray Absorptiometry (DXA). Both osteoporotic and non-osteoporotic patients will be enrolled. Sociodemographic data such as age, height, weight, and BMI will be recorded. Femoral neck and L1-L4 T-scores and BMD values will be obtained from existing DXA results. Information on osteoporosis treatment, presence of fecal incontinence, constipation, and medication use will be collected. In the second phase, sarcopenia will be assessed according to EWGSOP2 criteria using bioelectrical impedance analysis for skeletal muscle mass, handgrip strength, and the five-time sit-to-stand test. Differences between the osteoporotic and non-osteoporotic groups 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
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

June 25, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2025

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

June 22, 2025

Last Update Submit

June 22, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Skeletal Muscle Mass

    Measured by bioelectrical impedance analysis (BIA), this assesses the amount of muscle tissue in the body. Low skeletal muscle mass indicates sarcopenia.

    0 day

  • Handgrip Strength

    This is a simple test to measure muscle strength. Reduced handgrip strength is a sign of sarcopenia.

    0 day

  • 5 times chair stand test

    The Five Times Sit-to-Stand Test is a simple and widely used functional assessment tool to evaluate lower extremity muscle strength, balance, and mobility.

    0 day

Eligibility Criteria

Age50 Years - 59 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Postmenopausal women under 60 years

You may qualify if:

  • Women under 60 years of age who are postmenopausal.
  • Patients with or without a diagnosis of osteoporosis:
  • Osteoporosis group: T-score ≤ -2.5 in femoral neck or L1-L4 region. Control group: T-score ≥ -1.0 in femoral neck and L1-L4 region.
  • Patients who provide written informed consent to participate in the study.

You may not qualify if:

  • Refusal to participate in the study.
  • Presence of neuromuscular diseases that could cause muscle loss.
  • History of infection, recent surgery, or trauma.
  • Presence of psychiatric disorders.
  • Cognitive impairment that could interfere with test performance or data reliability.
  • Use of medications that could affect study outcomes (e.g., corticosteroids, muscle relaxants, or medications influencing bone/muscle metabolism).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 22, 2025

First Posted

July 1, 2025

Study Start

June 25, 2025

Primary Completion

July 25, 2025

Study Completion

July 25, 2025

Last Updated

July 1, 2025

Record last verified: 2025-06