NCT03832088

Brief Summary

The study was performed on 53 postmenopausal osteoporosis patients who presented to our osteoporosis outpatient clinic. Following written informed consent, patients were evaluated for sarcopenia according to the sarcopenia algorithm proposed by the European Working Group on Sarcopenia in Older People (EWGSOP). Algorithm parameters were walking speed, muscle strength and muscle mass measurements. We used Timed Up and Go Test (TUG) for evaluation of walking speed, Jamar Hand Dynamometer for muscle strength assessment, and calf circumference for muscle mass measurement. Balances of the patients were evaluated with Berg Balance Scale (BBS) and functional skills were evaluated with the Timed Up and Go Test (TUG). Other clinical parameters (age, body mass index (BMI), 25OHvitD level, menopause age, fall within the last year, fracture history, history of fracture in mother) were questioned.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

February 2, 2019

Last Update Submit

February 19, 2019

Conditions

Osteoporosis, PostmenopausalBalance; DistortedSarcopenia

Keywords

osteoporosissarcopeniabalance disorder

Outcome Measures

Primary Outcomes (2)

  • sarcopenia in postmenopausal osteoporotic patients

    sarcopenia evaluated according to EWGSOP algorithm which includes walking speed, muscle strength and muscle mass measures

    6 months

  • balance disorder in postmenopausal osteoporotic patients

    balance evaluated by Berg Balance Scale ( 0-56 scored scale , bigger score indicates better balance, scores under 41 indicates bigger risk of falling )

    6 months

Study Arms (1)

postmenopausal osteoporosis

EXPERIMENTAL

Postmenopausal osteoporotic patients evaluated for sarcopenia and balance disorders

Diagnostic Test: Berg Balance ScaleDiagnostic Test: Timed Up and Go TestDiagnostic Test: Jamar hand dynamometerDiagnostic Test: Calf circumference

Interventions

Berg Balance ScaleDIAGNOSTIC_TEST

Berg Balance Scale performed for balance disorder

postmenopausal osteoporosis
Timed Up and Go TestDIAGNOSTIC_TEST

Timed Up and Go Test for walking speed

postmenopausal osteoporosis
Jamar hand dynamometerDIAGNOSTIC_TEST

Jamar hand dynamometer for grip strength which correlates with muscle strength of patient

postmenopausal osteoporosis
Calf circumferenceDIAGNOSTIC_TEST

Calf circumference for muscle mass evaluation. Calf circumference is an anthropometric measurement which correlates with muscle mass.

postmenopausal osteoporosis

Eligibility Criteria

Age50 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmenopausal osteoporotic patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having postmenopausal osteoporosis
  • No other disease that can cause balance disorder
  • Volunteer participation in the study

You may not qualify if:

  • To have a disease that will cause balance disorder,
  • Having understanding problem to prevent communication with the patient,
  • The lack of motor function to the balance device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department

Istanbul, 34732, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoporosis, PostmenopausalSarcopeniaOsteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Research Assistant of PMR

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 6, 2019

Study Start

August 1, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

February 21, 2019

Record last verified: 2019-02

Locations

TU(1)