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M Diaz-Curiel

Publications and source records attributed to M Diaz-Curiel.

7 recordsLinked to original sources
PubMed2001

Measuring quality of life in women with vertebral fractures due to osteoporosis: a comparison of the OQLQ and QUALEFFO.

INTRODUCTION: Studies comparing the performance of health-related quality of life instruments in osteoporosis are lacking. We compared the feasibility, validity and reliability of the osteoporosis quality of life questionnaire (OQLQ) and the QUALEFFO (test version) in women with vertebral deformities due to osteoporosis. METHODS: Three hundred and thirty-eight patients diagnosed with primary osteoporosis and vertebral deformity and a random sample of 304 women from the general population (control group) were recruited. Patients and controls were randomly assigned to receive either the OQLQ or the QUALEFFO, and the SF-36 and EQ-5D. Test-retest reliability was assessed in the patient group. RESULTS: The QUALEFFO had more items with missing data and took slightly longer to administer (20.7 vs. 18.7 min). Cronbach's alpha and intraclass correlation coefficient (ICC) values for OQLQ domains (alpha: 0.75-0.91; ICC: 0.85-0.93) were slightly higher than for the QUALEFFO (alpha: 0.63-0.90; and ICC: 0.80-0.93). OQLQ and QUALEFFO domain scores correlated as expected with SF-36 and EQ-5D domains. Both questionnaires discriminated between patients and controls though the OQLQ showed slightly better discriminant power. DISCUSSION: The superior performance of the OQLQ in terms of administration time, missing responses, and discriminatory capacity needs to be weighed against the advantages of using a self-administered instrument such as the QUALEFFO. A full comparison also requires data on sensitivity to change.

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Comparison of the efficacy and bioequivalence of two oral formulations of tiludronate in the treatment of Paget's disease of bone.

Tiludronate, an oral bisphosphonate used to treat Paget's disease of bone, is currently being studied as a treatment for osteoporosis. A multicenter, open-label, parallel-group study was performed to compare the efficacy of two tablet formulations of tiludronate in the treatment of Paget's disease. Eighty-eight patients with active Paget's disease were recruited. The diagnosis was based on radiologic evidence of bone lesions, and all patients included in the study had serum alkaline phosphatase (SAP) levels equal to or more than twice the upper normal value of the local laboratory that assayed the sample. Each patient received treatment with oral tiludronate 400 mg/d for 84 +/- 2 days; 39 patients received the previously tested tablet formulation 3C1, and 49 patients received formulation 9O1, which is prepared using an improved manufacturing technique. The objective of this study was to determine whether the two formulations have an equivalent therapeutic effect, the primary end point being SAP levels in both groups after 3 months of treatment. This equivalence is commonly assessed by comparing pharmacokinetic data; however, in previous studies of tiludronate, large intra-individual variability prevented statistically valid comparisons of the data. Therefore, in addition to pharmacokinetic data, biochemical and clinical response data were collected during the trial. The secondary objectives of the trial were to measure the plasma levels and to assess the efficacy and safety of the two tiludronate formulations. The relative pharmacologic activities of the two formulations were assessed by comparison of the confidence intervals of levels of SAP at monthly intervals. After 3 months of treatment, the 90% confidence interval of the difference between the formulations was included in the reference confidence interval. These findings suggest that the 9O1 and 3C1 formulations did not show a significant difference in therapeutic activity. Furthermore, after 3 months of treatment, the frequency of normalization of SAP levels was 30.6% in the 9O1 treatment group and 28.2% in the 3C1 treatment group. The percentage of patients responding to treatment (defined as a decrease in SAP levels of at least 50% from baseline) was 67.3% in the 9O1 treatment group and 69.2% in the 3C1 treatment group. Statistical analyses performed on the maximum and minimum plasma concentrations of tiludronate showed no significant differences between the two formulations. In this trial, the two tablet formulations of tiludronate demonstrated therapeutic and pharmacokinetic equivalence.

Administration, Oral↗