Osteoporosis, PostmenopausalNCT03832088
Sarcopenia And Balance In Postmenopausal Osteoporosis
A study testing Berg Balance Scale, Timed Up and Go Test and Jamar hand dynamometer in people with Osteoporosis, Postmenopausal and Balance; Distorted, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal, Balance; Distorted, Sarcopenia
- What is being tested?
- Berg Balance Scale, Timed Up and Go Test and Jamar hand dynamometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having postmenopausal osteoporosis
- No other disease that can cause balance disorder
- Volunteer participation in the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
Istanbul, 34732
Bilinç Doğruöz Karatekin, +905368308709, bilincdogruoz@hotmail.com
Bilinç Doğruöz Karatekin, MD
About this study
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.
Read the detailed description
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. SPSS 22.0 program will be used for statistical evaluation and correlation analysis will be done.
- Conditions
- Osteoporosis, Postmenopausal, Balance; Distorted, Sarcopenia
- Being tested
- Berg Balance Scale, Timed Up and Go Test, Jamar hand dynamometer, Calf circumference
- Keywords
- osteoporosis, sarcopenia, balance disorder
- Medical subject headings
- Osteoporosis, Postmenopausal, Sarcopenia, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berg Balance ScaleDiagnostic test
Berg Balance Scale performed for balance disorder
Timed Up and Go TestDiagnostic test
Timed Up and Go Test for walking speed
Jamar hand dynamometerDiagnostic test
Jamar hand dynamometer for grip strength which correlates with muscle strength of patient
Calf circumferenceDiagnostic test
Calf circumference for muscle mass evaluation. Calf circumference is an anthropometric measurement which correlates with muscle mass.
| Study group | Role | What they receive |
|---|---|---|
| postmenopausal osteoporosis | Experimental | Postmenopausal osteoporotic patients evaluated for sarcopenia and balance disorders Receives: Diagnostic Test: Berg Balance Scale; Diagnostic Test: Timed Up and Go Test; Diagnostic Test: Jamar hand dynamometer; Diagnostic Test: Calf circumference |
What is being measured
The primary outcome is the main question the study is designed to answer.
sarcopenia in postmenopausal osteoporotic patients
sarcopenia evaluated according to EWGSOP algorithm which includes walking speed, muscle strength and muscle mass measures
Measured: 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 )
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Aug 2018
- Primary completion31 Mar 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832088
- Sponsor's protocol ID
- MedeniyetOP
- Status last verified
- Feb 2019
- First submitted
- 2 Feb 2019
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia And Balance In Postmenopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT03832088
- Acronym / sponsor ID
- MedeniyetOP
- Conditions
- Osteoporosis, Postmenopausal, Balance; Distorted, Sarcopenia
- Keywords
- osteoporosis, sarcopenia, balance disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. SPSS 22.0 program will be used for statistical evaluation and correlation analysis will be done.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postmenopausal osteoporosis | Experimental | Diagnostic Test: Berg Balance Scale, Diagnostic Test: Timed Up and Go Test, Diagnostic Test: Jamar hand dynamometer, Diagnostic Test: Calf circumferencePostmenopausal osteoporotic patients evaluated for sarcopenia and balance disorders |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having postmenopausal osteoporosis
- No other disease that can cause balance disorder
- Volunteer participation in the study
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berg Balance ScaleBerg Balance Scale performed for balance disorder | Diagnostic test | postmenopausal osteoporosis |
| Timed Up and Go TestTimed Up and Go Test for walking speed | Diagnostic test | postmenopausal osteoporosis |
| Jamar hand dynamometerJamar hand dynamometer for grip strength which correlates with muscle strength of patient | Diagnostic test | postmenopausal osteoporosis |
| Calf circumferenceCalf circumference for muscle mass evaluation. Calf circumference is an anthropometric measurement which correlates with muscle mass. | Diagnostic test | postmenopausal osteoporosis |
Primary outcome
sarcopenia in postmenopausal osteoporotic patients
Time frame: 6 months
sarcopenia evaluated according to EWGSOP algorithm which includes walking speed, muscle strength and muscle mass measures
balance disorder in postmenopausal osteoporotic patients
Time frame: 6 months
balance evaluated by Berg Balance Scale ( 0-56 scored scale , bigger score indicates better balance, scores under 41 indicates bigger risk of falling )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berg Balance Scale, Timed Up and Go Test and Jamar hand dynamometer in people with Osteoporosis, Postmenopausal and Balance; Distorted, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sarcopenia in postmenopausal osteoporotic patients (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.