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)

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.

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Effects of teriparatide in postmenopausal women with osteoporosis pre-treated with bisphosphonates: 36-month results from the European Forsteo Observational Study

Acta Endocrinologica ◽

10.1530/eje-11-0740 ◽

2012 ◽

Vol 166 (1) ◽

pp. 87-97 ◽

Cited By ~ 31

Author(s):

F Jakob ◽

H Oertel ◽

B Langdahl ◽

O Ljunggren ◽

A Barrett ◽

...

Keyword(s):

Back Pain ◽

Observational Study ◽

Postmenopausal Women ◽

Repeated Measures ◽

Bisphosphonate Therapy ◽

Teriparatide Treatment ◽

Routine Clinical Setting ◽

Pain Visual Analog Scale ◽

Clinical Fractures

ObjectivesTo describe fracture rates, back pain, and health-related quality of life (HRQoL) in postmenopausal women with osteoporosis and prior bisphosphonate therapy, treated with teriparatide for up to 18 months and followed up for a further 18 months.DesignProspective, multinational, and observational study.MethodsData on prior bisphosphonate use, clinical fractures, back pain visual analog scale (VAS), and HRQoL (EQ-5D) were collected over 36 months. Fracture data were summarized in 6-month intervals and analyzed using logistic regression with repeated measures. Changes from baseline in back pain VAS and EQ-VAS were analyzed using a repeated measures model.ResultsOf the 1581 enrolled patients with follow-up data, 1161 (73.4%) had a history of prior bisphosphonate use (median duration: 36 months). Of them, 169 (14.6%) sustained ≥1 fracture during 36-month follow-up. Adjusted odds of fracture were significantly decreased at each 6-month interval compared with the first 6 months of teriparatide treatment: 37% decrease in the 12 to <18 months period during teriparatide treatment (P=0.03) and a 76% decrease in the 12- to 18-month period after teriparatide was discontinued (P<0.001). Significant reductions in back pain and improvement in HRQoL were observed.ConclusionsPostmenopausal women with severe osteoporosis previously treated with bisphosphonates had a significant reduction in the incidence of fractures compared with the first 6 months of therapy, a reduction in back pain and an improvement in HRQoL during up to 18 months of teriparatide treatment. These outcomes were still evident for at least 18 months after teriparatide was discontinued. The results should be interpreted in the context of an uncontrolled, observational study in a routine clinical setting.

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Effectiveness of Teriparatide in Postmenopausal Women with Osteoporosis and Glucocorticoid Use: 3-Year Results from the EFOS Study

The Journal of Rheumatology ◽

10.3899/jrheum.110947 ◽

2012 ◽

Vol 39 (3) ◽

pp. 600-609 ◽

Cited By ~ 24

Author(s):

DIMITRIOS KARRAS ◽

IVAYLO STOYKOV ◽

WILLEM F. LEMS ◽

BENTE L. LANGDAHL ◽

ÖSTEN LJUNGGREN ◽

...

Keyword(s):

Back Pain ◽

Observational Study ◽

Postmenopausal Women ◽

Repeated Measures ◽

Study Data ◽

Teriparatide Treatment ◽

Routine Clinical Setting ◽

Related Quality ◽

Health Related ◽

Clinical Fractures

Objective.To describe clinical fracture rates, back pain, and health-related quality of life (HRQOL) in postmenopausal women with osteoporosis who are receiving glucocorticoids (GC), during a 36-month study of teriparatide treatment for up to 18 months, with an additional 18-month followup period when patients were receiving other osteoporosis medications.Methods.A prospective, multinational, observational study. Data for clinical fractures, back pain (by visual analog scale; VAS) and HRQOL (by EQ-5D) were collected over 36 months. Fracture data were summarized in 6-month segments and analyzed using logistic regression with repeated measures. Changes from baseline in back pain VAS and EQ-VAS were analyzed.Results.Of 1581 enrolled women with followup data, 294 (18.6%) had antecedents of GC use. Of these, 49 (16.7%) patients sustained a total of 69 fractures during the 36-month study period. Adjusted odds of fracture were significantly decreased during the last year of followup compared with the first 6 months of teriparatide treatment: an 81% decrease in the 24 to < 30-month period (p < 0.05), and an 89% decrease in the 30 to < 36-month period (p < 0.05). There were significant reductions in back pain and improvements in HRQOL in both groups of GC users and nonusers.Conclusion.Postmenopausal women with severe osteoporosis receiving GC, who were treated with teriparatide for up to 18 months, showed a reduced incidence of clinical fractures during the third year while receiving sequential osteoporosis treatments compared with the first 6 months, together with reduced back pain and improved HRQOL. Our results should be interpreted in the context of an uncontrolled observational study in a routine clinical setting.

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Teriparatide in East Asian Postmenopausal Women with Osteoporosis in a Real-World Setting: A Baseline Analysis of the Asia and Latin America Fracture Observational Study (ALAFOS)

Clinical Interventions in Aging ◽

10.2147/cia.s228158 ◽

2020 ◽

Vol Volume 15 ◽

pp. 111-121 ◽

Cited By ~ 1

Author(s):

Chung-Hwan Chen ◽

Seung-Jae Lim ◽

Jong-Keon Oh ◽

Tsan-Wen Huang ◽

Yuhong H Zeng ◽

...

Keyword(s):

Latin America ◽

Observational Study ◽

Postmenopausal Women ◽

Real World ◽

East Asian ◽

Real World Setting

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Teriparatide in East Asian Postmenopausal Women with Osteoporosis in a Real-World Setting: A Baseline Analysis of the Asia and Latin America Fracture Observational Study (ALAFOS) [Corrigendum]

Clinical Interventions in Aging ◽

10.2147/cia.s250325 ◽

2020 ◽

Vol Volume 15 ◽

pp. 341-342

Author(s):

Chung-Hwan Chen ◽

Seung-Jae Lim ◽

Jong-Keon Oh ◽

Tsan-Wen Huang ◽

Yuhong H Zeng ◽

...

Keyword(s):

Latin America ◽

Observational Study ◽

Postmenopausal Women ◽

Real World ◽

East Asian ◽

Real World Setting

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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)

Advances in Rheumatology ◽

10.1186/s42358-019-0088-2 ◽

2019 ◽

Vol 59 (1) ◽

Cited By ~ 2

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.

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