SAT0452 DIFFERENT PROFILE OF RISK OF FRACTURE IN PATIENTS TREATED WITH ANTI-OSTEOPOROTIC DRUGS IN ITALY USING A NEW ALGORITHM

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1183-1183
Author(s):  
G. Adami ◽  
A. Fassio ◽  
A. Giollo ◽  
G. Orsolini ◽  
O. Viapiana ◽  
...  

Background:A new algorithm for management of patients at low, high and very high risk of osteoporotic fractures has been recently proposed, has been also recommended treating those patients at very high risk of fracture with bone anabolics (1). A similar treatment algorithm has been applied in Italy since 2015, when the “Nota 79”, that regulates the reimbursability for osteoporosis medications, has been developed by the Italian Agency for Drugs (AIFA) (2).Objectives:In the present study, using a new mathematical and computerized algorithm, we seek to investigate the profile of risk of fracture of patients starting treatment with different anti-osteoporotic medications in Italy.Methods:We retrospectively analyzed the 10-year risk of major osteoporotic fracture calculated with the DeFRAcalc79 tool in postmenopausal women aged over 50 years that were initiating an anti-osteoporotic treatment (fully reimbursed according to the Nota 79). DeFRAcalc79 is a new web-based fracture risk-assessment tool (https://defra-osteoporosi.it) that arithmetically adjusts the risk based on the integration of multiple risk factors contemplated by the AIFA’s Nota 79, including: demographic and anthropometric data, femoral and/or lumbar spine BMD T-score, family history of femoral or vertebral fractures, number and site of previous osteoporotic fracture (including vertebral, femoral, and nonvertebral nonfemoral fractures), glucocorticoid treatment (> 3 or > 12 months, ≥5 mg prednisone or equivalent), adjuvant hormone therapy for breast or prostate cancer, and comorbidities that increase the risk (rheumatoid arthritis and other connective tissue diseases, chronic obstructive pulmonary disease, inflammatory bowel diseases, Parkinson’s disease, multiple sclerosis, HIV infection, diabetes, or severe physical handicap).Results:We retrieved data for 10,235 women prescribed with an anti-osteoporotic treatment.Figure 1shows the mean 10-year fracture risk estimated with DeFRAcalc79 tool at the time of the treatment initiation. Teriparatide users had the highest 10-year risk of fracture (67.4% Standard Deviation [SD] 21.5%). We found that in 2,231 patients starting denosumab, the 10-year baseline risk of fracture was 38.5%, SD 22.8%. In 5,759 patients initiating alendronate was 25.7%, SD 15.3% and in patients initiating risedronate was 27.9%, SD 26.9%. Patients prescribed with zoledronic acid had a mean 10-year risk of fracture of 35.6%, SD 21.6. P values between means were all <0.01.Figure 1.Mean 10-year risk of fracture estimated with DeFRAcalc79 tool at the time of treatment initiation, p< 0.01 between all means.Conclusion:The risk of fracture of Italian post-menopausal women initiating different anti-osteoporotic medications varies significantly. Teriparatide is prescribed to patients with greater risk of fracture. The Nota 79 correctly individuates patients at very high risk of fracture that merit treatment with a bone anabolic. Denosumab and zoledronic acid are prescribed to patients with a greater risk of fracture compared to oral bisphosphonates.DeFRAcalc79 is a useful and practical tool for the integrated evaluation of the profile of risk of fracture.References:[1]Kanis JA et al. Algorithm for the management of patients at low, high and very high risk of osteoporotic fractures. Osteoporos Int 2019 31:1–12.https://doi.org/10.1007/s00198-019-05176-3[2]Adami G et al. Comments on Kanis et al.: Algorithm for the management of patients at low, high, and very high risk of osteoporotic fractures. Osteoporos Int. 2020. doi: 10.1007/s00198-020-05302-6. [Epub ahead of print]Disclosure of Interests:Giovanni Adami: None declared, Angelo Fassio Speakers bureau: Angelo Fassio reports personal fees from: Abiogen and Novartis, outside the submitted work., Alessandro Giollo: None declared, Giovanni Orsolini: None declared, Ombretta Viapiana: None declared, Davide Gatti Speakers bureau: Davide Gatti reports personal fees from Abiogen, Amgen, Janssen-Cilag, Mundipharma, outside the submitted work., Maurizio Rossini Speakers bureau: AbbVie, Abiogen, Amgen, BMS, Eli-Lilly, Novartis, Pfizer, Sanofi, Sandoz and UCB

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1342.1-1342
Author(s):  
A. Efremova ◽  
O. Nikitinskaya ◽  
N. Toroptsova ◽  
O. Dobrovolskaya ◽  
N. Demin

Background:Objectives:To assess the frequency of fragility fractures and the 10-year risk of major osteoporotic fractures using the fracture risk assessment tool (FRAX) tool in patients with systemic sclerosis (SSc).Methods:The study included 136 patients with SSc who met the ACR/EULAR 2013 criteria: 110 (80.9%) postmenopausal women and 26 (19.1%) men over 50 years of age, mean age 59,3 + 7.5 years. The duration of the disease was 10,0 [6.0; 15.0] years in women and 6,0 [3.5; 9.0] years in men. A questionnaire was conducted and the risk of major osteoporotic fractures was calculated according to FRAX tool, as a result of which patients were divided into groups of low, moderate or high risk. Individuals at moderate risk underwent dual-energy X-ray absorptiometry (DXA) of the proximal femur, followed by a 10-year probability of major osteoporotic fractures recalculation with the inclusion of the femoral neck T-score. According to the obtained fracture risk assessment tool value, patients were assigned as having a low, high or very high risk.Results:Fragility fractures of various localization were found in 50 (36,7%) people: 41 (37,3%) women and 9 (34.6%) men. Vertebral and peripheral bone fractures occurred with the same frequency (19,8%) without significant differences depending on the patient’s gender. Only 1 (3,8%) male had a history of proximal femoral fracture. Fractures of both the vertebra and the peripheral bone occurred in 4 (2,9%) people: 3 (2,7%) women and 1 (3,8%) man.9 (8,2%) women and 16 (61,5%) men had a low risk of major osteoporotic fractures according to FRAX, 60 (54,5%) and 10 (38,5%) - a moderate risk, respectively, while 41 (37,3%) women were at high risk. Among 86 patients without a history of low-energy fractures (69 women and 17 men), 8 (11,6%) women and 16 (94,1%) men were at low risk of major osteoporotic fractures, and 57 (82,6%) and 1 (5,9%), respectively, were at moderate risk. Only 4 (5,8%) women were assigned to the high-risk group. After recalculation of the fracture risk assessment tool with inclusion of the femoral neck T-score in persons with moderate risk without a history of fragility fractures, 9 (13,0%) women and 1 (5,9%) man were found to be at high risk, 14 (20,3%) women - at very high risk and 34 (49,3%) women - at low risk.Among moderate-risk patients with prior fractures after FRAX recalculation 3 (7,3%) women and 7 (77,8%) men became at low risk, 1 (11,1%) male - at high and 1(11,1%) male – at very high risk. Thus, 55 (50,0%) women and 1 (3,8%) man were at very high, 12 (10,9%) and 2 (7,7%), respectively, - at high, and 43 (39,1%) and 23 (88,5%), respectively, - at low risk of major osteoporotic fractures.Conclusion:In the examined cohort of patients with SSc, the frequency of fragility fractures was 37,3% in women and 34,6% in men. A high and very high risk of major osteoporotic fractures was found in 60,9% of women and 11,5% of men. 3 (2,7%) women and 6 (23,1%) men with a history of previous fractures were in the low-risk group by FRAX, but they need to consider the appointment of anti-osteoporotic therapy as for patients at high and very high risk.Disclosure of Interests:None declared.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 834.2-835
Author(s):  
P. Kozhevnikova ◽  
P. Kovalenko ◽  
S. Glukhova ◽  
I. Dydykina ◽  
A. Lila

Background:FRAX is a computer-based algorithm that calculates the 10-year probability of a major osteoporotic fracture and the 10-year probability of hip fracture. However, FRAX has several limitations in assessing the risk of fracture in patients with rheumatoid arthritis (RA).In 2013 V.A. Nasonova Reasearch Institute of Rheumatology (Russia) developed a predictive mathematical model for assessing the risk of osteoporotic fractures in RA, which includes 2 main risk factors: cumulative glucocorticoid dose (GC), decrease in BMD in the femoral neck to osteoporosis, and 2 additional factors: for patients under 65 years of age - the presence of ischemic heart disease, and for people over 65 - a history of gastric ulcer or duodenal ulcer.Objectives:To compare accuracy of osteoporotic fracture risk prediction in patients with RA using the predictive model developed at V.A. Nasonova Reasearch Institute of Rheumatology (IR) and FRAX.Methods:This monocentric (single-center) prospective study included 70 patients with RA, aged 40 to 80 years. The follow-up period - 8.0 ± 1.2 years; mean age at the baseline was 55.4±7.8 years old; the mean disease duration at the baseline - 14,7±10,2 years. All patients retrospectively calculated the 10-year probability of fractures and prognostic model developed by the IR.Results:According to the Fracture Risk Assessment Tool, 32 (46%) patients had a low risk of osteoporotic fractures, 38 (54%) had a high risk. According to the predictive model of IR 33 (47%) patients had a low risk of osteoporotic fractures, 37 (53%) had a high risk. During the follow-up period, osteoporotic fractures were occurred in 18 (26%) patients: 14 (78%) of them had a high risk of fractures according to the predictive IR model, and 13 (72%) patients - according to the Fracture Risk Assessment Tool. Positive and negative predictive value of the Fracture Risk Assessment Tool was 34% and 84%, respectively, of the predictive model of IR - 38% and 88%, respectively. Prognosis of the predictive model of IR in 73% cases coincided with assessing the 10-year probability of fracture.Conclusion:The predictive model developed at V.A. Nasonova Reasearch Institute of Rheumatology (Russia) showed a higher sensitivity and specificity in determining the risk of osteoporotic fractures in RA patients vs FRAX algorithm.Disclosure of Interests:None declared.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1185.1-1186
Author(s):  
G. Adami ◽  
A. Fassio ◽  
A. Giollo ◽  
G. Orsolini ◽  
O. Viapiana ◽  
...  

Background:Glucocorticoid-induced osteoporosis and osteoporosis induced by adjuvant hormone therapy for breast cancer are the most common forms of secondary osteoporosis.Objectives:The exact real-life prevalence of treatment with anti-osteoporotic drugs in women with drug-induced osteoporosis is not known. In the present study, using a new mathematical and computerized algorithm, we investigate the profile of risk of fracture of women with drug-induced osteoporosis and the prevalence of treatment with anti-osteoporotic drugs.Methods:We have retrospectively analyzed the 10-year risk of major osteoporotic fracture calculated with the DeFRAcalc79 tool in postmenopausal women aged over 50 years that were initiating an anti-osteoporotic treatment (fully reimbursed according to the Nota 79). DeFRAcalc79 is a new web-based fracture risk-assessment tool (https://defra-osteoporosi.it) that arithmetically adjusts the risk based on multiple risk factors contemplated by the Nota 79, which regulates the reimbursability for osteoporosis medications in Italy (Italian Agency for Drugs, AIFA), including demographic and anthropometric data, femoral and/or lumbar spine BMD T-score, family history of femoral or vertebral fractures, number and site of previous osteoporotic fracture (including vertebral, femoral, and non-vertebral non-femoral fractures), glucocorticoid treatment (> 3 or > 12 months, ≥5 mg prednisone or equivalent), adjuvant hormone therapy for breast cancer, and comorbidities that induce an increased risk of fracture (rheumatoid arthritis and other connective tissue diseases, chronic obstructive pulmonary disease, inflammatory bowel diseases, Parkinson’s disease, multiple sclerosis, human immunodeficiency virus infection, diabetes, or severe physical handicap). This is a sub-analysis of the cross-sectional observational study to validate and further develop the DeFRA algorithm for the estimation of the risk of osteoporotic fractures, promoted by Verona hospital with the unconditional support of Amgen Srl.Results:Among 208 women, 116 (55.8%) were treated with adjuvant hormone therapy for breast cancer and 92 (44.2%) were on glucocorticoid ≥5 mg/day. Women on glucocorticoids had a greater mean 10-year risk of fracture compared to women on adjuvant hormone therapy for breast cancer (67.0% vs 39.1% p<0.01). 50.7% of women on adjuvant hormone therapy for breast cancer used denosumab, 28.0% zoledronic acid and 17.3% alendronate. In glucocorticoid-induced osteoporosis, 17.6% of the women used teriparatide, 37.3% alendronate, 29.4% zoledronic acid and 13.7% denosumab.Conclusion:In our cohort of patients, treatment with adjuvant hormone therapy for breast cancer was slightly more common than glucocorticoids. Women with glucocorticoid-induced osteoporosis had a greater risk of fracture compared to patients treated with adjuvant hormone therapy for breast cancer. Half of the patients on adjuvant hormone therapy for breast cancer were prescribed with denosumab. One-fifth of the patients with glucocorticoid-induced osteoporosis was treated with teriparatide. DeFRAcalc79 is a useful and practical tool for the integrated evaluation of fracture risk in drug-induced osteoporosis.Disclosure of Interests:Giovanni Adami: None declared, Angelo Fassio Speakers bureau: Angelo Fassio reports personal fees from: Abiogen and Novartis, outside the submitted work., Alessandro Giollo: None declared, Giovanni Orsolini: None declared, Ombretta Viapiana: None declared, Davide Gatti Speakers bureau: Davide Gatti reports personal fees from Abiogen, Amgen, Janssen-Cilag, Mundipharma, outside the submitted work., Maurizio Rossini Speakers bureau: AbbVie, Abiogen, Amgen, BMS, Eli-Lilly, Novartis, Pfizer, Sanofi, Sandoz and UCB


2021 ◽  
Vol 3 (1) ◽  
pp. 02-09
Author(s):  
Qiaocong Chen ◽  
◽  
Huiling Lou ◽  
Cheng Peng

The risk of osteoporotic fracture can be viewed as a function of loading conditions and the ability of the bone to withstand the load. Skeletal loads are dominated by muscle action. Recently, it has become clear that bone and muscle share genetic determinants. Involvement of the musculoskeletal system manifests as bone loss (osteoporosis) and muscle wasting (sarcopenia). There is clinical evidence that osteoporotic fractures are significantly associated with sarcopenia, and sarcopenia may be a potential predictive factor for fracture risk, which suggests that there may be shared genetic determinants between sarcopenia and osteoporotic fracture. In recent years, genome-wide association studies (GWASs) studies have found that both lean mass and hand grip strength are associated with fracture risk, which may provide a possible endophenotype for elucidating the potential genetic study of fracture risk. Our effort to understand the clinical and genetic correlations between osteoporotic fracture and sarcopenia is helpful to understand the interaction between muscle and bone, and to study the etiology of complex musculoskeletal diseases. Identifying potentially important genetic variations in bone and muscle, measuring these variations using state-of-the-art technology, and replicating these experiments in humans and large animals will provide potential drug or intervention targets for osteoporotic fracture valuable in the future. Keywords: Genetics, osteoporosis, fracture, sarcopenia, genome-wide association studies, single nucleotide polymorphism


2019 ◽  
Vol 31 (1) ◽  
pp. 1-12 ◽  
Author(s):  
J. A. Kanis ◽  
N. C. Harvey ◽  
E. McCloskey ◽  
O. Bruyère ◽  
N. Veronese ◽  
...  

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1020.2-1020
Author(s):  
L. Marchenkova

Background:Taking a course of physical rehabilitation creates the prerequisites for falls and injuries in patients at high risk of fractures. Data on fracture risk and prevalence of osteoporosis in older patients starting medical rehabilitation can change the approach of doctors to the development of rehabilitation programs and the management of such patients.Objectives:To assess the prevalence of osteoporosis, individual risk factors for osteoporosis as well as the proportion of people with high risk of osteoporotic low-energy fractures among patients over 50 years old undergoing treatment according to the “medical rehabilitation” profile.Methods:The study group comprised of 600 patients (426 women and 174 men) aged 50 to 84 years, average age 64.25 ± 10.17 years, undergoing treatment in a rehabilitation department. This was a cross-sectional study in the form of unified questionnaire, including data concerning age, weight, height, BMI, clinical and rehabilitation diagnosis, anamnesis of the main disease, anamnesis vitae, presence of osteoporosis diagnosis in the anamnesis, its treatment, osteoporosis risk factors estimation. An assessment of 10-year probability of osteoporotic fractures was carried out using Russian model of online FRAX® calculator.Results:41.8% patients in the study sample had osteoporosis risk factors, including 31.2% of subjects had 3 risk factors or more. 38.0% patients showed a high fracture risk according to the FRAX calculator. 34.1% had a diagnosis of osteoporosis, and 45.8% already had osteoporotic fractures. Among those who did not undergo densitometry examination, 69.9% had a history of low-traumatic fractures, and only 58.5% of patients with an established diagnosis of osteoporosis and 26.8% of those at high risk of fractures received effective therapy for osteoporosis.Conclusion:Population of patients over 50 years old undergoing rehabilitation is characterized by high frequency of osteoporosis and probability of fractures, and insufficient quality of osteoporosis verification and anti-osteoporotic therapy administration at the same time.Disclosure of Interests:None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1935.2-1935
Author(s):  
D. Palma Sanchez ◽  
A. Haro ◽  
M. J. Moreno ◽  
E. Peñas ◽  
M. Mayor ◽  
...  

Background:Axial spondyloarthritis (SpAax) presents an increased risk of vertebral fracture not fully detected by Dual energy X-ray absorptiometry (DXA). The FRAX algorithms give the 10-year probability of hip fracture and of mayor osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture), taking into account 11 clinical risk factors.Objectives:To analyze the suitability of FRAX to detect the risk of fracture in patients with SpAax. To assess whether the incorporation of SpAax as a clinical risk factor to conventional FRAX provides additional information.Methods:Cross-sectional study in which SpAax patients (ASAS criteria) were included. Clinical-demographic and related to the disease variables were collected. FRIDEX model for Spanish population was used to determine low, intermediate or high risk of mayor fracture by FRAX. These results were compared with those obtained by DXA and trabecular bone score (TBS). In the statistical analysis we used mean and standard deviation (SD) in quantitative variables and frequency in qualitative ones. To compare means among 3 groups, ANOVA test was used.Results:The characteristics of the patients are shown in Table 1. According to FRIDEX, no patient had high risk of fracture and 2.4% had intermediate risk. When SpAax was added as a risk factor, no patient had high risk of fracture and 6.1% presented intermediate risk. According to DXA, 7.3% had high risk of fracture and 41.3% intermediate risk. TBS detected high risk of fracture in 18.3% and intermediate risk also in 18.3% of patients.Table 1.Sociodemographic, clinical and related characteristics with the disease (BMD: bone mineral density, BMI: index of body mass)Gender (Male), n (%)61 (74.4)Age, mean ± SD49.48 ± 12.47BMI, mean ± SD27.13 ± 4.42Smoking, n (%)26 (31.7)Diabetes mellitus, n (%)9 (11)Osteoporotic fracture, n (%)1 (1.2)Disease duration (years), mean ± SD11.77 ± 10syndesmophytes, n (%)38 (46.3)ASDAS-PCR, mean ± SD2.55 ± 1.07Lumbar BMD (g / cm2), mean ± SD1.032 ± 0.180BMD femoral neck (g / cm2), mean ± SD0.816 ± 0.140Lumbar TBS, mean ± SD1.383 ± 0.133Conclusion:FRAX does not seem an adequate tool to detect the risk of fracture in patients with SpAax since it did not improve the results obtained by DXA meanwhile TBS did. The incorporation of SpAax as a clinical risk factor to conventional FRAX did not provide additional information in most casesDisclosure of Interests:None declared


Author(s):  
Bhoomika G. Brahmbhatt ◽  
Megha S. Sheth

Background: This study was conducted to estimate the prevalence of fracture risk among middle-aged and elderly population of Gujarat and to find out the prevalence of the clinical risk factors (CRF) and its significance with risk of fracture. To compare the risk of fracture among men and women.Methods: An observational study included 500 participants both men and women, in age group of 40-80 years. Participants were assessed with the fracture risk assessment tool (FRAX) without BMD to evaluate the 10-year probability of risk of Major osteoporotic fracture (MOF) and Hip fracture (HF). India-specific age-dependent thresholds were used to categorize the participants into safety zone and treatment zone followed by statistical analysis. Level of significance was kept at 5%.Results: Total 500 participants, 56.8% males and 43.2% females with mean age 56.3±9.7 years. As per the estimated prevalence, 22% participants were in treatment zone and 78% were in safety zone for HF risk and for major osteoporotic fracture risk, 24% participants were in treatment zone and 76% were in safety zone. In 18.6% participants the hip fracture risk was ≥3% and in 2% participants the major osteoporotic fracture risk was ≥20%. Women had more fracture risk compare to men, for HF [t (464.6)=-3.04, p=0.002] and for MOF [t (441.3)=-5.13, p<0.001]. Significant difference in fracture risk was found with presence of CRF except with smoking and alcohol use.Conclusions: FRAX can be used to identify the 10-year probability of fracture risk. The prevalence showed fewer participants in treatment zone and more in safety zone. Women had higher fracture probabilities than men.


2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Akeem A. Yusuf ◽  
Yan Hu ◽  
David Chandler ◽  
Daria B. Crittenden ◽  
Richard L. Barron

Abstract Summary Advancing age, female sex, recent prior fracture and falls, and specific comorbidities and medications contribute to imminent (within 1–2 years) risk of fracture in Medicare enrollees. Clinician awareness of these risk factors and their dynamic nature may lead to improved osteoporosis care for elderly patients. Purpose The burden of osteoporotic fracture disproportionately affects the elderly. Growing awareness that fracture risk can change substantially over time underscores the need to understand risk factors for imminent (within 1–2 years) fracture. This study assessed predictors of imminent risk of fracture in the US Medicare population. Methods Administrative claims data from a random sample of Medicare beneficiaries were analyzed for patients aged ≥ 67 years on January 1, 2011 (index date), with continuous coverage between January 1, 2009 and March 31, 2011, excluding patients with non-melanoma cancer or Paget’s disease. Incident osteoporotic fractures were identified during 12 and 24 months post-index. Potential predictors were age, sex, race, history of fracture, history of falls, presence of osteoporosis, cardiovascular diseases, chronic obstructive pulmonary disorder (COPD), mood/anxiety disorders, polyinflammatory conditions, difficulty walking, use of durable medical equipment, ambulance/life support, and pre-index use of osteoporosis medications, steroids, or central nervous system medications. Cox proportional hazards models were used to evaluate predictors of fracture risk in the two follow-up intervals. Results Among 1,780,451 individuals included (mean age 77.7 years, 66% female), 8.3% had prior fracture and 6.1% had a history of falls. During the 12- and 24-month follow-up periods, 3.0% and 5.4% of patients had an incident osteoporotic fracture, respectively. Imminent risk of fracture increased with older age (double/triple), female sex (> 80%), recent prior fracture (> double) and falls, and specific comorbidities and medications. Conclusions Demographics and factors including fall/fracture history, comorbidities, and medications contribute to imminent risk of fracture in elderly patients.


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