Assessing the risk of osteoporotic fractures: the Ecuadorian FRAX model

Gavilánez, Enrique López; Johansson, Helena; McCloskey, Eugène; Harvey, Nicholas C.; Bajaña, Angel Segale; D, Blum; Grijalva, Mario Navarro; Curiel, Manuel Dı́az; Kanis, John А.

doi:10.1007/s11657-019-0644-8

Cited by 15 publications

(10 citation statements)

References 31 publications

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“…The increasing recognition of differences in fracture risk is also reflected in the development of country-specific FRAX® models [16][17][18][19][20]. Overall, the importance of ethnicity in determining fracture risk, alongside other factors such as time since fracture [21], is increasingly being recognised as a consideration for the personalised approach to osteoporosis treatment [10].…”

Section: Discussionmentioning

confidence: 99%

Romosozumab efficacy and safety in European patients enrolled in the FRAME trial

et al. 2022

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In this post hoc analysis, we assessed romosozumab efficacy and safety in European patients enrolled in FRAME. Romosozumab treatment through 12 months, followed by denosumab for a further 24 months, resulted in early and sustained risk reduction for major fracture categories, associated with large gains in bone mineral density. Introduction In the multinational FRAME phase 3 trial of romosozumab in postmenopausal women with osteoporosis, marked differences between clinical and non-vertebral fracture outcomes were observed among patients from Central and Southern America versus rest of world. This post hoc analysis assessed romosozumab efficacy and safety in European patients enrolled in the FRAME trial and extension study. Methods In FRAME (NCT01575834), patients were randomised 1:1 to romosozumab 210 mg or placebo monthly (QM) for 12 months, followed by open-label denosumab 60 mg Q6M to month 36, including a 12-month extension study. We report incidence of major fracture outcomes, bone mineral density (BMD) change from baseline and safety for European patients enrolled in FRAME. ResultsIn FRAME, 3013/7180 (41.96%) patients were European; 1494 received romosozumab and 1519 received placebo. Through 12 months, romosozumab reduced fracture risk versus placebo for non-vertebral fracture (1.4% versus 3.0%; p = 0.004), clinical fracture (1.4% versus 3.6%; p < 0.001), new vertebral fracture (0.4% versus 2.1%; p < 0.001) and major osteoporotic fracture (0.9% versus 2.8%; p < 0.001), with results sustained through 36 months following transition to denosumab. Hip fractures were numerically reduced with romosozumab at month 12 (0.2% versus 0.6%; p = 0.092). Romosozumab increased BMD versus placebo at month 12; all patients in the romosozumab and placebo groups experienced further increases by month 36 after transition to denosumab. Adverse events were balanced between groups. Conclusions Among European patients in FRAME, romosozumab resulted in early and sustained risk reduction for all major fracture categories, associated with large BMD gains that continued after transition to denosumab.

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Section: Discussionmentioning

confidence: 99%

Romosozumab efficacy and safety in European patients enrolled in the FRAME trial

et al. 2022

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“…In a previous publication, we described the age-specific fracture probabilities based on the FRAX model, as well as the treatment thresholds and BMD evaluation for our country 15 . We used the intervention thresholds approach used by the NOGG in the United Kingdom 5,19 , but applied to the Ecuadorian FRAX model 15 .…”

Section: Discussionmentioning

confidence: 99%

“…A FRAX model for Ecuador was released in 2012 11,12 , but recently, the model has been revised and modified using more current fracture and mortality rates 13,14 . In 2019, the new age-specific evaluation and treatment thresholds for the population of Ecuador were announced 15 .…”

Section: Originalsmentioning

confidence: 99%

“…The probabilities in the next 10 years of suffering a major osteoporotic fracture (MOF) and a hip fracture were calculated using the Ecuadorian FRAX model (version 4.1) 15 . There was no confirmed diagnosis of secondary osteoporosis and rheumatoid arthritis (RA), so these data were recorded as "NO", following the recommendations of the FRAX questionnaire.…”

Section: Fracture Probabilitiesmentioning

confidence: 99%

“…The intervention and evaluation thresholds specific to the Ecuadorian population and the methodology used to obtain them have been described in a previous publication 15 and are presented in table 1 and figure 1.…”

Section: Thresholdsmentioning

confidence: 99%

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Eficacia clínica de los umbrales de intervención híbridos y dependientes de la edad basados en FRAX® en la población ecuatoriana

Gavilánez¹,

Jara²,

Naula³

et al. 2022

Rev Osteoporos Metab Miner

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Objetive: To assess the clinical impact of FRAX-based intervention thresholds in Ecuadorian women. Also to test a combination of fixed and age-specific intervention thresholds to optimize the selection of women eligible for intervention. Patients and methods:Transversal study in which 2,283 women aged 60 to 94 years were selected. We calculated the risk of major osteoporotic and femoral neck fractures with the Ecuadorian FRAX model (version 4.1), and calculated the proportion of individuals eligible for treatment and bone mineral density assessment applying age-specific thresholds of 60 to 94 years and a fixed threshold from 75 years. Results: Applying age-specific thresholds, 2% of women qualified for treatment and 73.7% for bone mineral density assessment. Depending on age, women eligible for treatment ranged from 0.7 to 3.8% and those eligible for bone mineral density evaluation from 58.3 to 80.5%. With the fixed threshold, 31% of women qualified for treatment and 76.3% for bone mineral density assessment. Depending on age, women potentially eligible for treatment ranged from 3.8% to 76.5%, and those eligible for bone mineral density assessment from 65.2% to 85.4%. Conclusions:The proportion of women potentially eligible for treatment is low compared to countries with a high risk of fractures. Using a fixed threshold starting at age 75 optimizes the proportion of women eligible for treatment. In low to moderate fracture risk countries with limited resources, a hybrid model may be more appropriate.

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Position statement of the Latin American Federation of Endocrinology on osteoporosis

Gavilánez¹

2021

Arch Osteoporos

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Assessing the risk of osteoporotic fractures: the Ecuadorian FRAX model

Cited by 15 publications

References 31 publications

Romosozumab efficacy and safety in European patients enrolled in the FRAME trial

Romosozumab efficacy and safety in European patients enrolled in the FRAME trial

Eficacia clínica de los umbrales de intervención híbridos y dependientes de la edad basados en FRAX® en la población ecuatoriana

Position statement of the Latin American Federation of Endocrinology on osteoporosis

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