OsteoporosisNCT04259099

Validation of the Turkish Version of QUALEFFO-31

An observational study of Osteoporosis, run by Bugra Ince at 1 site in Turkey (Türkiye).

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Osteoporosis
What is being tested?: Testing the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31(QUALEFFO-31)
How many people: 111 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 13 Feb 2020to 1 Feb 2021
How long will I take part?: 1 Day
Phase: Observational
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
All sexes
No healthy volunteers
Adult, Older adult

Study population: Females and males aged 50 and older with osteoporosis, osteopenia or normal bone mineral density.

Who may be able to join

To have Dual-energy X-ray absorptiometry (DXA) results and thoracolumbar lateral spine X-Rays taken for any reason in the last 6 months.
To have calcium, phosphorus, parathormone (PTH) and 25-hydroxyvitamin D level in the last 3 months.
To be independently ambulatory.
To have a cognitive capacity to understand and complete the questionnaires.

Who cannot join

To have malignancy.
To have inflammatory diseases.
To have a metabolic bone disease other than osteoporosis.
To have neuromuscular diseases.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Bezmialem Vakif University Hospital
Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Validation of the Turkish Version of Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31)

The aim of this study is to investigate the adaptation and validity of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 in patients with osteoporosis. Thus, to present a scale that will help us analyze the psychometric properties of patients with osteoporosis to the use of the Turkish people .

Read the detailed description

Osteoporosis has become an important public health problem due to low bone mass, decreased bone strength and increased risk of fractures. Today, the measurement of quality of life plays an important role in the approach to diseases. Quality of Life Questionnaire of the European Foundation for Osteoporosis-41 (QUALEFFO-41) has been used for many years as a well-established and fully self-administered questionnaire. In the following years, a shorter and more practical version was needed because the QUALEFFO-41 contains many questions and takes a long time. For this reason, the questionnaire was updated in 2006 and the version of QUALEFFO-31 was made and the validity of the current questionnaire was shown. The aim of this study is to conduct the reliability and validity study of Turkish version of QUALEFFO-31 and to evaluate the power of the questionnaire to distinguish patients with osteoporosis.

Conditions: Osteoporosis
Being tested: Testing the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31(QUALEFFO-31)
Keywords: osteoporosis, Questionnaire, Quality of Life, QUALEFFO
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Testing the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31(QUALEFFO-31)Other
Also called Testing the Short Form-36 (SF-36)
Administer the questionnaires to 150 participants to classify their status of quality of life.

Study groups in NCT04259099
Study group	Role	What they receive
QUALITY OF LIFE QUESTIONNAIRES		The group is anticipated to consist of 150 female and male with osteoporosis, osteopenia or normal bone mineral density. Receives: Other: Testing the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31(QUALEFFO-31)

What is being measured

The primary outcome is the main question the study is designed to answer.

Reliability and validity of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31
Internal consistency will be tested with Cronbach Alpha coefficient. Intergroup reliability and consistency will be evaluated by T-Test.
Measured: Through study completion, an average of 6 months
Correlation between Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 and Short Form-36.
The Spearman Correlation Analysis will be used for the correlation between QUALEFFO-31 and SF-36.
Measured: Through study completion, an average of 6 months
Testing Short Form-36
SF-36 is a self-assessment instrument. It consists of eight domains: bodily pain, physical functioning, social functioning, general health, mental health, vitality, and role restrictions due to physical and emotional problems.SF-36 is scored from 0 to 100. 0 indicated poor health status and 100 indicated good health status.
Measured: Through study completion, an average of 6 months
Testing Quality of Life Questionnaire of the European Foundation for Osteoporosis-31
QUALEFFO-31 is a self-assessment instrument. It consists of three domains: pain,physical function and a mental function. QUALEFFO-31 is scored from 0 to 100. Domain scores were calculated by summing the scores of questions included in the domain and submitting the sum to a linear transformation to a scale of 100. Zero indicated good health status and 100 indicated poor health status.
Measured: Through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 20201 Feb 2021

First posted6 Feb 2020
Study start13 Feb 2020
Primary completion1 Feb 2021
Study completion1 Feb 2021

Why it stopped: Except in compulsory cases hospital admissions have been decreased significantly due to the pandemic. The study was terminated due to significant decrease in enrollment rate.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for OsteoporosisStudies 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: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 111 participants (actual)
Target duration: 1 Day

IDs, dates and publications

ClinicalTrials.gov ID: NCT04259099
Sponsor's protocol ID: 54022451-050.05.04-01/16
Status last verified: Mar 2021
First submitted: 2 Feb 2020
Last updated: 11 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

van Schoor NM, Knol DL, Glas CA, Ostelo RW, Leplege A, Cooper C, Johnell O, Lips P. Development of the Qualeffo-31, an osteoporosis-specific quality-of-life questionnaire. Osteoporos Int. 2006;17(4):543-51. doi: 10.1007/s00198-005-0024-7. Epub 2005 Dec 14.
PubMed 16362146
Lips P, Cooper C, Agnusdei D, Caulin F, Egger P, Johnell O, Kanis JA, Kellingray S, Leplege A, Liberman UA, McCloskey E, Minne H, Reeve J, Reginster JY, Scholz M, Todd C, de Vernejoul MC, Wiklund I. Quality of life in patients with vertebral fractures: validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Working Party for Quality of Life of the European Foundation for Osteoporosis. Osteoporos Int. 1999;10(2):150-60. doi: 10.1007/s001980050210.
PubMed 10501796
Ince B, Kucukakkas O. The reliability and validity of the Turkish version of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31). Arch Osteoporos. 2021 Sep 9;16(1):128. doi: 10.1007/s11657-021-00997-4.
PubMed 34499238

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
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TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
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Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of the Turkish Version of Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31)
ClinicalTrials.gov ID: NCT04259099
Acronym / sponsor ID: 54022451-050.05.04-01/16
Conditions: Osteoporosis
Keywords: osteoporosis, Questionnaire, Quality of Life, QUALEFFO
Study type: Observational
Recruitment status: TerminatedReason stopped: Except in compulsory cases hospital admissions have been decreased significantly due to the pandemic. The study was terminated due to significant decrease in enrollment rate.
Enrolment: 111 participants (actual)
Lead sponsor: Bugra InceUniversity, hospital or other
Study start: 13 Feb 2020 (actual)
Primary completion: 1 Feb 2021 (actual)
Study completion: 1 Feb 2021 (actual)
First posted: 6 Feb 2020 (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.

Detailed description

Study design

Observational model: Case only
Time perspective: Cross-sectional
Target follow-up: 1 Day
Number of arms: 1

Arm	Type	Receives
QUALITY OF LIFE QUESTIONNAIRES	–	Other: Testing the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31(QUALEFFO-31)The group is anticipated to consist of 150 female and male with osteoporosis, osteopenia or normal bone mineral density.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Females and males aged 50 and older with osteoporosis, osteopenia or normal bone mineral density.

Key inclusion criteria (4 listed)

To have Dual-energy X-ray absorptiometry (DXA) results and thoracolumbar lateral spine X-Rays taken for any reason in the last 6 months.
To have calcium, phosphorus, parathormone (PTH) and 25-hydroxyvitamin D level in the last 3 months.
To be independently ambulatory.
To have a cognitive capacity to understand and complete the questionnaires.

Key exclusion criteria (4 listed)

To have malignancy.
To have inflammatory diseases.
To have a metabolic bone disease other than osteoporosis.
To have neuromuscular diseases.

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
Testing the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31(QUALEFFO-31)Also: Testing the Short Form-36 (SF-36)Administer the questionnaires to 150 participants to classify their status of quality of life.	Other	QUALITY OF LIFE QUESTIONNAIRES

Primary outcome

Reliability and validity of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31
Time frame: Through study completion, an average of 6 months
Internal consistency will be tested with Cronbach Alpha coefficient. Intergroup reliability and consistency will be evaluated by T-Test.
Correlation between Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 and Short Form-36.
Time frame: Through study completion, an average of 6 months
The Spearman Correlation Analysis will be used for the correlation between QUALEFFO-31 and SF-36.
Testing Short Form-36
Time frame: Through study completion, an average of 6 months
SF-36 is a self-assessment instrument. It consists of eight domains: bodily pain, physical functioning, social functioning, general health, mental health, vitality, and role restrictions due to physical and emotional problems.SF-36 is scored from 0 to 100. 0 indicated poor health status and 100 indicated good health status.
Testing Quality of Life Questionnaire of the European Foundation for Osteoporosis-31
Time frame: Through study completion, an average of 6 months
QUALEFFO-31 is a self-assessment instrument. It consists of three domains: pain,physical function and a mental function. QUALEFFO-31 is scored from 0 to 100. Domain scores were calculated by summing the scores of questions included in the domain and submitting the sum to a linear transformation to a scale of 100. Zero indicated good health status and 100 indicated poor health status.

Results and safety

The study was stopped early (reason given: Except in compulsory cases hospital admissions have been decreased significantly due to the pandemic. The study was terminated due to significant decrease in enrollment rate.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
Background: PubMed 16362146van Schoor NM, Knol DL, Glas CA, Ostelo RW, Leplege A, Cooper C, Johnell O, Lips P. Development of the Qualeffo-31, an osteoporosis-specific quality-of-life questionnaire. Osteoporos Int. 2006;17(4):543-51. doi: 10.1007/s00198-005-0024-7. Epub 2005 Dec 14.
Background: PubMed 10501796Lips P, Cooper C, Agnusdei D, Caulin F, Egger P, Johnell O, Kanis JA, Kellingray S, Leplege A, Liberman UA, McCloskey E, Minne H, Reeve J, Reginster JY, Scholz M, Todd C, de Vernejoul MC, Wiklund I. Quality of life in patients with vertebral fractures: validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Working Party for Quality of Life of the European Foundation for Osteoporosis. Osteoporos Int. 1999;10(2):150-60. doi: 10.1007/s001980050210.
Derived from this study: PubMed 34499238Ince B, Kucukakkas O. The reliability and validity of the Turkish version of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31). Arch Osteoporos. 2021 Sep 9;16(1):128. doi: 10.1007/s11657-021-00997-4.
Individual participant dataSharing planned: Undecided

Related trials for Osteoporosis

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis

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.

Bugra Ince, MD principal investigator

Bezmialem Vakif University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoporosis, run by Bugra Ince 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 11 Mar 2021. 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?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reliability and validity of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (time frame: Through study completion, an average of 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04259099, which also lists 3 linked publications.

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 11 Mar 2021.