scholarly journals Reassessment of Fracture Risk in Women After 3 Years of Treatment With Zoledronic Acid: When is it Reasonable to Discontinue Treatment?

2014 ◽  
Vol 99 (12) ◽  
pp. 4546-4554 ◽  
Author(s):  
Felicia Cosman ◽  
Jane A. Cauley ◽  
Richard Eastell ◽  
Steven Boonen ◽  
Lisa Palermo ◽  
...  
Keyword(s):  
Zoledronic Acid ◽  
Fracture Risk ◽  
Discontinue Treatment

scholarly journals Fracture Risk and Zoledronic Acid Therapy in Men with Osteoporosis

2012 ◽  
Vol 367 (18) ◽  
pp. 1714-1723 ◽  
Author(s):  
Steven Boonen ◽  
Jean-Yves Reginster ◽  
Jean-Marc Kaufman ◽  
Kurt Lippuner ◽  
Jose Zanchetta ◽  
...  
Keyword(s):  
Zoledronic Acid ◽  
Fracture Risk ◽  
Acid Therapy

scholarly journals A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures

2016 ◽  
Vol 20 (78) ◽  
pp. 1-406 ◽  
Author(s):  
Sarah Davis ◽  
Marrissa Martyn-St James ◽  
Jean Sanderson ◽  
John Stevens ◽  
Edward Goka ◽  
...  
Keyword(s):  
Systematic Review ◽  
Zoledronic Acid ◽  
Fracture Risk ◽  
Fragility Fractures ◽  
Clinical Effectiveness ◽  
Controlled Trials ◽  
Bisphosphonate Treatment ◽  
Oral Bisphosphonates ◽  
Oral Bisphosphonate ◽  
Significant Difference

BackgroundFragility fractures are fractures that result from mechanical forces that would not ordinarily result in fracture.ObjectivesTo evaluate the clinical effectiveness and safety of bisphosphonates [alendronic acid (Fosamax®and Fosamax®Once Weekly, Merck Sharp & Dohme Ltd), risedronic acid (Actonel®and Actonel Once a Week®, Warner Chilcott UK Ltd), ibandronic acid (Bonviva®, Roche Products Ltd) and zoledronic acid (Aclasta®, Novartis Pharmaceuticals UK Ltd)] for the prevention of fragility fracture and to assess their cost-effectiveness at varying levels of fracture risk.Data sourcesFor the clinical effectiveness review, six electronic databases and two trial registries were searched: MEDLINE, EMBASE, The Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, Web of Science and BIOSIS Previews, Clinicaltrials.gov and World Health Organization International Clinical Trials Registry Platform. Searches were limited by date from 2008 until September 2014.Review methodsA systematic review and network meta-analysis (NMA) of effectiveness studies were conducted. A review of published economic analyses was undertaken and a de novo health economic model was constructed. Discrete event simulation was used to estimate lifetime costs and quality-adjusted life-years (QALYs) for each bisphosphonate treatment strategy and a strategy of no treatment for a simulated cohort of patients with heterogeneous characteristics. The model was populated with effectiveness evidence from the systematic review and NMA. All other parameters were estimated from published sources. A NHS and Personal Social Services perspective was taken, and costs and benefits were discounted at 3.5% per annum. Fracture risk was estimated from patient characteristics using the QFracture®(QFracture-2012 open source revision 38, Clinrisk Ltd, Leeds, UK) and FRAX®(web version 3.9, University of Sheffield, Sheffield, UK) tools. The relationship between fracture risk and incremental net benefit (INB) was estimated using non-parametric regression. Probabilistic sensitivity analysis (PSA) and scenario analyses were used to assess uncertainty.ResultsForty-six randomised controlled trials (RCTs) were included in the clinical effectiveness systematic review, with 27 RCTs providing data for the fracture NMA and 35 RCTs providing data for the femoral neck bone mineral density (BMD) NMA. All treatments had beneficial effects on fractures versus placebo, with hazard ratios varying from 0.41 to 0.92 depending on treatment and fracture type. The effects on vertebral fractures and percentage change in BMD were statistically significant for all treatments. There was no evidence of a difference in effect on fractures between bisphosphonates. A statistically significant difference in the incidence of influenza-like symptoms was identified from the RCTs for zoledronic acid compared with placebo. Reviews of observational studies suggest that upper gastrointestinal symptoms are frequently reported in the first month of oral bisphosphonate treatment, but pooled analyses of placebo-controlled trials found no statistically significant difference. A strategy of no treatment was estimated to have the maximum INB for patients with a 10-year QFracture risk under 1.5%, whereas oral bisphosphonates provided maximum INB at higher levels of risk. However, the PSA suggested that there is considerable uncertainty regarding whether or not no treatment is the optimal strategy until the QFracture score is around 5.5%. In the model using FRAX, the mean INBs were positive for all oral bisphosphonate treatments across all risk categories. Intravenous bisphosphonates were estimated to have lower INBs than oral bisphosphonates across all levels of fracture risk when estimated using either QFracture or FRAX.LimitationsWe assumed that all treatment strategies are viable alternatives across the whole population.ConclusionsBisphosphonates are effective in preventing fragility fractures. However, the benefit-to-risk ratio in the lowest-risk patients may be debatable given the low absolute QALY gains and the potential for adverse events. We plan to extend the analysis to include non-bisphosphonate therapies.Study registrationThis study is registered as PROSPERO CRD42013006883.FundingThe National Institute for Health Research Health Technology Assessment programme.

scholarly journals EFFECT OF ZOLEDRONIC ACID THERAPY ON FRACTURE RISK IN THE TREATMENT OF MEN WITH OSTEOPOROSIS

2012 ◽  
Vol 15 (3) ◽  
pp. 40-40
Author(s):  
Steven Boonen ◽  
Jean-Yves Reginster ◽  
Jean-Marc Kaufman
Keyword(s):  
Zoledronic Acid ◽  
Fracture Risk ◽  
Acid Therapy

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 ◽  
...  
Keyword(s):  
Zoledronic Acid ◽  
High Risk ◽  
Fracture Risk ◽  
Osteoporotic Fracture ◽  
Treatment Initiation ◽  
Osteoporotic Fractures ◽  
Similar Treatment ◽  
Risk Of Fracture ◽  
Link Type ◽  
Very High

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

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