scholarly journals SAT0456 REAL-LIFE RISK OF FRACTURE AND TREATMENT PREVALENCE IN DRUG-INDUCED OSTEOPOROSIS IN ITALY USING A NEW ALGORITHM

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

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


2015 ◽  
Vol 33 (20) ◽  
pp. 2262-2269 ◽  
Author(s):  
Wei He ◽  
Fang Fang ◽  
Catherine Varnum ◽  
Mikael Eriksson ◽  
Per Hall ◽  
...  

Purpose To identify predictors of discontinuation of adjuvant hormone therapy in patients with breast cancer. Patients and Methods We conducted a record-linkage study based on data from Stockholm-Gotland Breast Cancer Register, Swedish Prescribed Drug Register, and self-reported questionnaire. Women diagnosed with breast cancer between 2005 and 2008 in Stockholm, Sweden, were prospectively followed for 5 years until 2013, starting from their first prescription of tamoxifen or aromatase inhibitors (N = 3,395). Results Family history of ovarian cancer (hazard ratio [HR], 1.55; 95% CI, 1.19 to 2.02); younger (< 40 years; HR, 1.39; 95% CI, 1.08 to 1.78) and older (≥ 65 years; HR, 1.15; 95% CI, 1.03 to 1.28) age; higher Charlson comorbidity index (≥ 2 v 0; HR, 1.35; 95% CI, 1.03 to 1.76); and use of analgesics (HR, 1.33; 95% CI, 1.16 to 1.52), hypnotics/sedatives (HR, 1.24; 95% CI, 1.07 to 1.43), GI drugs (HR, 1.25; 95% CI, 1.08 to 1.43), and hormone replacement therapy (HR, 1.27; 95% CI, 1.08 to 1.49) were identified as baseline predictors for hormonal treatment discontinuation. Use of analgesics (HR, 1.22; 95% CI, 1.08 to 1.37), hypnotics/sedatives (HR, 1.21; 95% CI, 1.07 to 1.37), antidepressants (HR, 1.22; 95% CI, 1.06 to 1.40), or GI drugs (HR, 1.27; 95% CI, 1.13 to 1.43), and switching therapy between tamoxifen and aromatase inhibitors (HR, 1.50; 95% CI, 1.23 to 1.83) during the first year of hormonal treatment were associated with increased risk of discontinuation during the next 4 years. Conclusion Predictors identified in our study can be used in developing targeted intervention to prevent adjuvant hormone therapy discontinuation and subsequently to improve breast cancer outcomes.


Cancer ◽  
2010 ◽  
Vol 117 (2) ◽  
pp. 398-405 ◽  
Author(s):  
Tina W. F. Yen ◽  
Linda K. Czypinski ◽  
Rodney A. Sparapani ◽  
Changbin Guo ◽  
Purushottam W. Laud ◽  
...  

2019 ◽  
pp. 479-487
Author(s):  
Andrea K. Shimada ◽  
João Victor Machado Alessi ◽  
Bruna Zucchetti ◽  
Artur Katz

2017 ◽  
Vol 8 ◽  
pp. 18-22 ◽  
Author(s):  
Masashi Yanae ◽  
Shinichiro Fujimoto ◽  
Kaori Tane ◽  
Maki Tanioka ◽  
Kimiko Fujiwara ◽  
...  

2019 ◽  
Vol 2 (14) ◽  
pp. 38-44
Author(s):  
Ya. Z. Zaydieva

Hormone therapy is an effective treatment option for menopausal women, although prolonged use of hormone therapy is associated with a slightly increased risk of breast cancer, thromboembolism, and stroke. A literature search for studies evaluating the effects of hormone therapy in menopausal women with asymptomatic fibroids demonstrated variable effects of hormone therapy on the volume and size of the fibroids. Some studies have demonstrated an increase in size of pre-existing asymptomatic fibroids and formation of new fibroids with higher doses of progestogen in combination therapy. Selective estrogen receptor modulators having tissue-specific estrogen agonistic and antagonistic actions such as raloxifene have a favorable clinical profile and may be better alternatives in women with asymptomatic fibroids.


2018 ◽  
Vol 36 (20) ◽  
pp. 2061-2069 ◽  
Author(s):  
Rola Hamood ◽  
Hatem Hamood ◽  
Ilya Merhasin ◽  
Lital Keinan-Boker

Purpose Breast cancer treatments have been associated with an increased risk of multiple health-related adverse outcomes, but the relationship with diabetes remains unclear. This study investigated the association between hormone therapy and diabetes risk in breast cancer survivors. Patients and Methods We performed a case-cohort study of 2,246 female survivors recruited from the Leumit health care fund who were diagnosed with primary nonmetastatic invasive breast cancer in 2002 through 2012. A 20% random subcohort was sampled at baseline, and all diabetes cases were identified. Adjusted hazard ratios (HRs) with 95% CIs were estimated by weighted Cox proportional hazards regression models. Results Of 2,246 breast cancer survivors, 324 developed diabetes over a mean follow-up of 5.9 years. The crude cumulative incidence of diabetes that accounted for death as a competing risk was 20.9% (95% CI, 18.3% to 23.7%). In multivariable-adjusted models, hormone therapy was associated with increased diabetes risk (HR, 2.40; 95% CI, 1.26 to 4.55; P = .008). The hazard for tamoxifen use (HR, 2.25; 95% CI, 1.19 to 4.26; P = .013) was less pronounced than the use of aromatase inhibitors (HR, 4.27, 95% CI, 1.42 to 12.84; P = .010). Conclusion Active hormone therapy is a significant risk factor of diabetes among breast cancer survivors. Although cessation of treatment is not recommended because the survival benefits of hormone therapy outweigh the risks, preventive strategies aimed at lifestyle modifications may minimize the risk.


2006 ◽  
Vol 21 (2) ◽  
pp. 111-122
Author(s):  
R. Longo ◽  
M.R. D'Andrea ◽  
G. Gasparini

For the past 15 years tamoxifen has been the standard adjuvant hormone therapy for women with early-stage breast cancer and estrogen receptor (ER)-positive tumors, irrespective of nodal status and other clinicopathological parameters. Recent studies provided evidence that the optimal duration of tamoxifen treatment is 5 years. Based on the positive clinical results obtained with the administration of aromatase inhibitors (AIs) in the metastatic setting, several controlled clinical trials have evaluated the efficacy and side effects of AIs versus standard tamoxifen also as adjuvant therapy in postmenopausal breast cancer patients. The results of the above studies, suggest a therapeutic advantage of AIs over tamoxifen with regard to relapse-free survival and the risk of metachronous contralateral breast cancer. We review the rationale and the available clinical data on initial or sequential hormone treatment with AIs and we propose a novel scenario for possible therapeutic strategies based on the clinicopathological characteristics of the patients and on the biology of each single tumor.


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