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Autor/a:
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Zwart, Marta; Azagra, Rafael; Encabo, Gloria; Aguyé, Amada; Roca, Genís; Güell, Sílvia; Puchol, Núria; Gene, Emili; López-Expósito, Francesc; Solà, Silvia; Ortiz, Sergio; Sancho, Pilar; Abado, Liz; Iglesias, Milagros; Pujol Salud, Jesús; Díez-Pérez, Adolf
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Notas:
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Background: Osteoporosis is a serious health problem that worsens the quality of life and the survival rate of
individuals with this disease on account the osteoporotic fractures. Studies have long focused on women, and its
presence in men has been underestimated. While many studies conducted in different countries mainly assess
health-related quality of life and identify fracture risks factors in women, few data are available on a Spanish male
population.
Methods/Design: Observational study.
Study population: Men ≥ 40 years of age with/without diagnosed osteoporosis and with/without osteoporotic
fracture included by their family doctor.
Measurements: The relationship between customary clinical risk factors for osteoporotic fracture and healthrelated
quality of life in a Spanish male population. A telephone questionnaire on health-related quality of life is
made.
Statistical analysis: The association between qualitative variables will be assessed by the Chi-square test. The
distribution of quantitative variables by Student’s t-test. If the conditions for using this test are not met, the nonparametric
Mann-Whitney’s U test will be used.
The validation of the results obtained by the FRAX™ tool will be performed by way of the Hosmer-Lemeshow test
and by calculating the area under the Receiver Operating Characteristic (ROC) curve (AUC). All tests will be
performed with a confidence intervals set at 95%.
Discussion: The applicability and usefulness of Health-related quality of life (HRQOL) studies are well documented
in many countries. These studies allow implementing cost-effective measures in cases of a given disease and
reducing the costly consequences derived therefrom. This study attempts to provide objective data on how quality
of life is affected by the clinical aspects involved in osteoporosis in a Spanish male population and can be useful
as well in cost utility analyses conducted by health authorities.
The sample selected is not based on a high fracture risk group. Rather, it is composed of men in the general
population, and accordingly comparisons should not lead to erroneous interpretations.
A possible bias correction will be ensured by checking reported fractures against healthcare reports and X-rays, or
by consulting health care centers as applicable. |
