Study description and baseline characteristics of the population enrolled in a multinational, observational study of teriparatide in postmenopausal women with osteoporosis: the Asia and Latin America Fracture Observational Study (ALAFOS)

2019 ◽  
Vol 35 (6) ◽  
pp. 1041-1049 ◽  
Author(s):  
Chung-Hwan Chen ◽  
Abdulaziz H. Elsalmawy ◽  
Sophia Ish-Shalom ◽  
Seung-Jae Lim ◽  
Nadia S. Al-Ali ◽  
...  
Keyword(s):  
Latin America ◽  
Observational Study ◽  
Postmenopausal Women ◽  
Baseline Characteristics

scholarly journals 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)

2019 ◽  
Vol 59 (1) ◽  
Author(s):  
Joao L. Cunha-Borges ◽  
Guillermo Meléndez Mier ◽  
Noemí Casas ◽  
Adriana Medina ◽  
Jose Fernando Molina ◽  
...  
Keyword(s):  
Latin America ◽  
Observational Study ◽  
Postmenopausal Women ◽  
Latin American ◽  
Real World Setting ◽  
Related Quality ◽  
Health Related ◽  
History Of ◽  
Fracture History

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.

scholarly journals The Effect of Teriparatide Treatment on the Risk of Fragility Fractures in Postmenopausal Women with Osteoporosis: Results from the Asian and Latin America Fracture Observational Study (ALAFOS)

2021 ◽  
Author(s):  
Chung-Hwan Chen ◽  
Abdulaziz H. Elsalmawy ◽  
Sophia Ish-Shalom ◽  
Seung-Jae Lim ◽  
Nadia S. AlAli ◽  
...  
Keyword(s):  
Latin America ◽  
Back Pain ◽  
Observational Study ◽  
Postmenopausal Women ◽  
Repeated Measures ◽  
Mixed Model ◽  
Real Life ◽  
Fragility Fractures ◽  
Teriparatide Treatment ◽  
Clinical Fractures

AbstractThe Asian and Latin America Fracture Observational Study (ALAFOS) is a prospective, observational, single-arm study conducted in 20 countries across Asia, Latin America and the Middle East. ALAFOS evaluated new clinical vertebral and non-vertebral fragility fractures in relation to time on teriparatide, in postmenopausal women with osteoporosis in real-life clinical practice. Clinical fragility fractures, back pain, and health-related quality of life (HRQoL) were recorded in 6-month intervals for ≤ 24 months during teriparatide treatment and up to 12-months post-treatment. Data were analysed with piecewise exponential regression with inverse probability weighting for time to event outcomes and mixed-model repeated measures for back pain and HRQoL. 3054 postmenopausal women started teriparatide and attended ≥ one follow-up visit (mean [SD] age 72.5 [10.4] years). The median (95% CI) time to treatment discontinuation was 22.0 months (21.2, 22.8). During the treatment period, 111 patients (3.6%) sustained 126 clinical fractures (2.98 fractures/100 patient-years). Rates of new clinical fragility fractures were significantly decreased during the > 6–12, > 12–18, and > 18–24-month periods, as compared with the first 6 months of treatment (hazard ratio [HR] 0.57; 95% CI 0.37, 0.88; p = 0.012; HR 0.35; 95% CI 0.19, 0.62; p < 0.001; HR 0.43; 95% CI 0.23, 0.83; p = 0.011; respectively). Patients also reported an improvement in back pain and HRQoL (p < 0.001). These results provide data on the real-world effectiveness of teriparatide in the ALAFOS regions and are consistent with other studies showing reduction of fractures after 6 months of teriparatide treatment. These results should be interpreted in the context of the noncontrolled design of this observational study.

scholarly journals Prevalence and Impact of Treatment-Resistant Depression in Latin America: a Prospective, Observational Study

2021 ◽  
Author(s):  
Bernardo Soares ◽  
Gabriela Kanevsky ◽  
Chei Tung Teng ◽  
Rodrigo Pérez-Esparza ◽  
Gerardo Garcia Bonetto ◽  
...  
Keyword(s):  
Latin America ◽  
Observational Study ◽  
Latin American ◽  
Prospective Observational Study ◽  
Rating Scale ◽  
Fisher Exact Test ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Work Impairment ◽  
Resistant Depression

AbstractApproximately one-third of patients with major depressive disorder (MDD) have treatment-resistant depression (TRD). The TRAL study will evaluate the prevalence and impact of TRD among patients with MDD in four Latin American countries. In this multicenter, prospective, observational study, patients with MDD were recruited from 33 reference sites in Mexico, Colombia, Brazil, and Argentina. Patients were assessed for TRD, defined as failure to respond to ≥ 2 antidepressant medications of adequate dose and duration. Demographics, previous/current treatments, depressive symptoms, functioning, healthcare resource utilization, and work impairment were also collected and evaluated using descriptive statistics, chi-square test, Fisher exact test, t-test for independent samples, or the Mann–Whitney nonparametric test, as appropriate. 1475 patients with MDD were included in the analysis (mean age, 45.6 years; 78% women); 89% were receiving relevant psychiatric treatment. 429 patients met criteria for TRD, and a numerically higher proportion of patients with TRD was present in public versus private sites of care (31% vs 27%). The mean Montgomery-Asberg Depression Rating Scale score was 25.0 among all MDD patients and was significantly higher for patients with TRD versus non-TRD (29.4 vs 23.3; P < 0.0001). Patients with TRD, versus those with non-TRD, were significantly more likely to be older, have a longer disease duration, have more comorbidities, be symptomatic, have a higher median number of psychiatric consultations, and report greater work impairment. Patients with TRD have a disproportionate burden of disease compared to those with non-TRD. Appropriate treatment for TRD is a substantial unmet need in Latin America. https://www.ClinicalTrials.gov identifier NCT03207282, 07/02/2017.

scholarly journals A prospective, observational study on conversion of Clinically Isolated Syndrome to Multiple Sclerosis during 4-year period (MS NEO study) in Taiwan

2018 ◽  
Author(s):  
Long-Sun Ro ◽  
Chih-Chao Yang ◽  
Rong-Kuo Lyu ◽  
Kon-Ping Lin ◽  
Tzung-Chang Tsai ◽  
...  
Keyword(s):  
Observational Study ◽  
Conversion Rate ◽  
Prognostic Significance ◽  
Risk Indicators ◽  
Clinical Event ◽  
First Episode ◽  
Conversion Rates ◽  
Demyelinating Lesions ◽  
Baseline Characteristics

AbstractImportanceCIS to MS conversion rates vary depending on population cohorts, initial manifestations, and durations of follow-up.ObjectiveTo investigate conversion rate of patients from CIS to MS and the prognostic significance of demographic and clinical variables in Taiwanese population.DesignNationwide, prospective, multi-centric, observational study from November 2008 to November 2014 with 4 years follow-up.SettingMulti-centre setting at 5 institutions in Taiwan.Participants152 patients having single clinical event potentially suggestive of MS in last 2 years were enrolled as consecutive sample. 33 patients were lost to follow-up and 16 patients did not complete the study.103 patients completed the study.Intervention(s) (for clinical trials) or Exposure(s) (for observational studies)Natural progression from first episode of CIS to MS or NMO was observed.Main Outcome(s) and Measure(s)Variables analysed were ‘proportion of patients converting to MS or NMO after first episode of CIS’, ‘duration between first episode of neurological event and diagnosis of MS’, ‘status of anti-AQP4 IgG’ and ‘length of longest contiguous spinal cord lesion in MS patients’. Association between baseline characteristics and progression to MS from CIS was analyzed using multiple logistic regression. Multivariate time dependent effect of baseline characteristics on progression to MS was plotted.Results14.5% patients with CIS converted to MS after 1.1 ± 1.0 years with greater predisposition (18.8%) in those having syndromes referable to the cerebral hemispheres. Conversion rate from ON to MS was 9.7%. 90.9% patients had benign disease course. 46.7% patients had abnormal MRIs at baseline, with 0.6±0.5 contrast enhanced lesions. ‘Below normal BMI’ and ‘MRI lesion load (≥ 4 lesions)’ were identified as risk indicators for the development of MS. Only 4.5% were positive for anti-AQP4 antibody in MS patients and amongst them, 80% were NMO patients as diagnosed by modern criteria.Conclusions and Relevance‘Below normal BMI’ and ‘number of demyelinating lesions (≥4)’ are significant predictors of conversion from CIS to MS. A low conversion rate to MS in Taiwanese CIS patients and majority of them having a benign course and minimal disability suggest the roles of geographic, genetic and ethnic factors.Trial RegistrationNon-trial observational study.

scholarly journals Middle East experience from the Asia And Latin America Fracture Observational Study (ALAFOS): Baseline characteristics of postmenopausal women with osteoporosis using teriparatide

2020 ◽  
Vol 48 (8) ◽  
pp. 030006052094085
Author(s):  
Abdul Aziz Elsalmawy ◽  
Nadia S. Al-Ali ◽  
Yasser Yaghi ◽  
Hussein Assaggaf ◽  
Ghassan Maalouf ◽  
...  
Keyword(s):  
Latin America ◽  
Middle East ◽  
Observational Study ◽  
United Arab Emirates ◽  
Clinical Characteristics ◽  
Rating Scale ◽  
Osteoporotic Fractures ◽  
Visual Analog Scale Score ◽  
Numeric Rating Scale ◽  
Mineral Density

Objective We aimed to describe the baseline clinical characteristics and fracture history of patients taking teriparatide in routine clinical practice in the Middle East (ME) subregional cohort of the Asia and Latin America Fracture Observational Study (ALAFOS). Methods Herein, we report baseline clinical characteristics of patients who were prescribed teriparatide (20 µg/day, subcutaneous injection) in four participant ME countries (Saudi Arabia, United Arab Emirates, Kuwait, and Lebanon). Results The ME cohort included 707 patients mean (SD) age 69.3 (11.6) years. Mean (SD) bone mineral density (BMD) T-scores at baseline were −3.13 (1.28) for lumbar spine, −2.88 (0.94) for total hip, and −2.65 (1.02) for femoral neck. Osteoporotic fractures after age 40 years were reported in 45.8% (vertebral fracture 14.4%, hip fracture 18.4%) and comorbidities in 57.4% of patients. Before starting teriparatide, 19.9% of patients took other osteoporosis medications. The median (Q1; Q3) EuroQoL 5-Dimension 5-Level visual analog scale score for perceived overall health status was 70 (50; 80). Mean (SD) worst back pain in the previous 24 hours was 4.0 (3.2) using a 10-point numeric rating scale. Conclusion This analysis indicated that in ME countries, teriparatide is usually prescribed to patients with low BMD and high comorbidities, with prior fractures.

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