Baseline characteristics of postmenopausal women with osteoporosis treated with teriparatide in a real-world setting in Latin America: a subregional analysis from the Asia and Latin America Fracture Observational Study (ALAFOS)

Abstract Background: Osteoporosis is a major healthcare concern in Latin America. Factors such as changing demographics, fragmented healthcare systems, and financial considerations may result in a huge increase in the burden of osteoporosis in this region. The aim of this article is to describe the baseline clinical characteristics and fracture history of patients who are prescribed teriparatide in normal clinical practice in Latin America. Methods: We conducted a prospective, multinational, observational study (the Asia and Latin America Fracture Observational Study [ALAFOS]) in 20 countries worldwide to assess the incidence of fractures in postmenopausal women with osteoporosis receiving teriparatide as a part of routine clinical practice in a real-world setting. In this subregional analysis of the ALAFOS study, we report the clinical characteristics, fracture history, risk factors for osteoporosis, comorbidities, previous osteoporosis therapies and health-related quality of life measures at baseline for patients from the four participant Latin American countries: Argentina, Brazil, Colombia, and Mexico. Results: The Latin America subregional cohort included 546 postmenopausal women (mean [SD] age: 71.0 [10.1] years; range: 40-94 years), constituting 18% of the ALAFOS total population. The baseline mean (SD) bone mineral density T-scores were - 3.02 (1.23) at the lumbar spine and - 2.31 (0.96) at the femoral neck; 62.8% of patients had a history of low trauma fracture after the age of 40 years and 39.7% of patients had experienced ≥1 fall in the past year. Osteoporosis medications were used by 70.9% of patients before initiating teriparatide. The median (Q1, Q3) EQ-5D-5 L Visual Analog Scale (VAS) scores for perceived health status at baseline was 70 (50, 80). The mean (SD) worst back pain numeric rating scale score for the overall Latin American cohort was 4.3 (3.4) at baseline. Conclusions: This baseline analysis of the Latin America subregion of the ALAFOS study indicates that patients who are prescribed teriparatide in the four participant countries had severe osteoporosis and high prevalence of fractures. They also had back pain and poor health-related quality of life. The proportions of patients with severe or extreme problems on the EQ-5D-5 L individual domains were lower than those in the overall ALAFOS study population.

Policondritis recurrente. Estudio de 19 casos en Colombia / Relapsing polychondritis. An study of 19 cases in Colombia

Objective: To describe clinical and paraclinical involvement in RP in a Colombian populationand compare it with another series previously published.Methods and materials: Retrospective review of 19 cases of RP presented in 4 rheumatologycenters in our country in the last 10 years. All patients met diagnostic criteria previouslyestablished. In every case, each clinical feature was analized and then compared with another9 series of RP previously published between 1966 y 2007.Results: Mean age at diagnosis was 46 years. A female predominance was observed ina relation 4:1. Mean follow-up was 4 years. Auricular condritis was the initial clinicalfeature in 89 percent of patients and finally was observed in the 100 percent of our report. Comparedwith other series, we found less frequently arthritis (21percent), ocular (10percent) and dermatologicinvolvement (10percent). Renal and neurologic involvement and the association between RPand another autoimmune disorder were found in the expected frequency. We not observedany cardiovascular involvement in our serie. All of the patients received corticosteroidsand 57percent had had another immunosuppressive medication. Observed mortality was 10percentby complications associated to RP.Conclusions: In contrast with another series from Caucasian and Oriental population, weobserved a marked predominance of female sex, a minor frequency of systemic involvementand auricular condritis is our most frequent initial clinical feature. Probably, these findingsare the result of a different genetic, immunological and environmental background.

Objetivo: Describir el comportamiento clínico y paraclínico de la PR en la poblacióncolombiana y comparar nuestros resultados con otras series publicadas.Materiales y métodos: Estudio descriptivo observacional de 19 casos de PR presentadosen 4 centros de reumatología del país durante los últimos 10 años. Los pacientes cumplieroncon el diagnóstico de PR de acuerdo al parámetro establecido...

Estudio multicéntrico para evaluar la efectividad y seguridad de una presentación de alendronato de sodio en cápsulas de gelatina blanda (Neobon 70 ®), en el tratamiento de osteoporosis posmenopáusica / Multicentre study to evaluate the effectiveness and security of sodium alendronate in a soft gelatin capsules in the treatment of postmenopausal osteoporosis

Objetivos: el objetivo del estudio fue evaluar la respuesta al tratamiento y seguridad del alendronato de sodio en una presentación de cápsulas blandas de gelatina (Neobon 70 ®), en mujeres posmenopáusicas con osteoporosis u osteopenia. Métodos: estudio clínico multicéntrico abierto a un año de tratamiento en mujeres postmenopáusicas. Las pacientes fueron asignadas a recibir 70 mg cada semana de alendronato sódico en presentación de cápsulas de gelatina blanda. Los desenlaces primarios fueron la densidad mineral ósea medida por DEXA y el valor plasmático del C-Telopéptido. La condición ósea fue evaluada por densitometría al inicio del estudio, al mes 6 y a los 12 meses de tratamiento. La resorción ósea fue evaluada por los niveles de C-Telopéptido basal, a los 3, 6 y 12 meses de tratamiento. Como desenlace secundario se evaluó la presentación de eventos adversos secundarios. Resultados: el estudio incluyó 146 mujeres reclutadas en diez centros de consulta externa de reumatología en cuatro ciudades de Colombia, que tuvieran diagnóstico de osteoporosis u osteopenia. La media de edad fue de 67±8 años (rango entre 45,7 y 92,8 años), y el promedio de tiempo transcurrido desde el inicio de la menopausia fue de 16±7,8 años. Treinta pacientes (20,54%) tenían una historia de fracturas previas. Al mes 12 de tratamiento se observó una reducción clínica y estadísticamente significativa en el nivel del C-Telopéptido (basal 0,53, tercer mes 0,22, sexto mes 0,17 y al año 0,17, p < 0,00001). Adicionalmente, se observó una mejoría estadísticamente significativa con el tratamiento en los valores del T-score a nivel de vértebras lumbares L2-L4 (basal -2,57, al sexto mes -2,27 y -2,29 al año), en el cuello de fémur (basal -2,37, al sexto mes -1,98 y al año -1,99), en el trocánter (basal -1,95, al sexto mes -1,55, y al año -1,41) y en la cadera (basal -1,73, al sexto mes -1,6 y -1,57 al año). También se observó mejoría en los parámetros de densidad mineral ósea, con un incremento de 2,3% a nivel vertebral lumbar y 2,59% en cadera. No hubo cambios en la densidad mineral ósea a nivel de cuello de fémur y trocánter. Estos cambios son similares a los observados con otras presentaciones de alendronatos y bifosfonatos. Como eventos adversos relacionados, solo se observó en el 8,2% la presencia de síntomas dispépticos, vértigo en el 3,4%, cefalea en el 2,7% y estreñimiento en el 1,4%. Conclusiones: estos resultados muestran que la presentación de alendronato sódico en cápsulas de gelatina blanda produce una gran mejoría en los parámetros evaluados por la densitometría y en el C-Telopéptido en mujeres posmenopáusicas con osteoporosis u osteopenia, y es una presentación farmacológica segura en mujeres jóvenes y de mayor edad.

Objectives: the purpose of this study was to evaluate the response to treatment and safety of Sodium Alendronate in a soft gelatin capsules presentation (Neobon 70 ®), in a postmenopausal women with osteoporosis or osteopenia. Methods: open multicenter clinical trial during one year was conducted in postmenopausal women. The patients were assigned to receive 70 mg of Sodic Alendronate in a soft gelatin capsule presentation, once time per week. The primaries endpoints were the bone density mineral measured by DEXA and the C-telopeptide serum level. The bone condition was evaluated by basal bone densitometry, 6 and 12 months. The bone resortion was evaluated by basal C-telopeptide serum levels, to 3, 6 and 12 months. The secondary endpoint was the presentation of secondary adverse events. Results: the study included 146 patients recruited in 10 rheumatologic clinical centers in Colombia, with diagnosis of osteopenia or osteporosis. Mean aged was 67±8 years (range 45.7 to 92.8 years) and the mean duration of menopausal time was 16±7.8 years. Thirty patients (20.54%) had a history of previous fracture bone. At month 12, a statistically significant reduction from base line in mean of C-telopeptide serum level was observed (basal 0.53, 3 month 0.22, 6 month 0.17 and 12 month 0.17, p < 0.00001). In addition, there was a clinical and statistically significant improvement in the T-score with the treatment in lumbar vertebrae L2-L4 (basal -2.57, 6 month -2.27 and 12 month -2.29), femur (basal -2.37, 6 month -1.98 and 12 month -1.99), trochanter (basal -1.95, 6 month -1.55 and 12 month -1.41), and in hip (basal -1.73, 6 month -1.6 and 12 month -1.57). Also it was observed an improvement in the parameters of bone density of 2.3% at lumbar vertebral level and of 2.59% in hip. No significant changes were observed in a left neck femur and trochanter. These increases are similar to observed with other presentations of alendronates and biphosphonates. Among this population, only the 8.2% had dyspeptic symptoms, 3.4% vertigo, 2.7% cephalea and 1.4% constipation. Conclusion: these findings showed that the presentation of sodium Alendronate in soft gelatin capsules produced a greater improvement in bone markers and densitometry scores in postmenopausal women with osteoporosis and osteopenia and is a safety pharmacological presentation in young and older patients.