Clinical trial NCT04259099: Validation of the Turkish Version of QUALEFFO-31
Official title: Validation of the Turkish Version of Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoporosis
Keywords: osteoporosis
Questionnaire
Quality of Life
QUALEFFO
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 111
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females and males aged 50 and older with osteoporosis, osteopenia or normal bone mineral density.

Brief summary: 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 .

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Reliability and validity of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31
timeFrame: Through study completion, an average of 6 months
measure: Correlation between Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 and Short Form-36.
timeFrame: Through study completion, an average of 6 months
measure: Testing Short Form-36
timeFrame: Through study completion, an average of 6 months
measure: Testing Quality of Life Questionnaire of the European Foundation for Osteoporosis-31
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University Hospital
Study officials:
affiliation: Bezmialem Vakif University Hospital
name: Bugra Ince, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.