Persistence with denosumab therapy in women affected by osteoporosis with fragility fractures: a multicenter observational real practice study in Italy

Migliaccio, Silvia; Francomano, Davide; Romagnoli, Elisabetta; Marocco, Chiara; Fornari, Rachele; Resmini, Giuseppina; Buffa, Angela; Pietro, Gioconda Di; Corvaglia, S.; Gimigliano, Francesca; Moretti, Antimo; Sire, Alessandro de; Malavolta, Nazzarena; Lenzi, Andrea; Greco, Emanuela A.; Iolascon, Giovanni

doi:10.1007/s40618-017-0701-3

Cited by 38 publications

(37 citation statements)

References 34 publications

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“…Previous persistence studies of denosumab covering the USA, Canada and several European countries excluding the UK have reported persistence at 12 months of 55.9-99.1% and at 24 months of 34.8-99.5% [24][25][26][27][28][29][30][31][32][33][34][35]. In contrast, for other parenteral therapies, the previous studies reported persistence at 12 months of 33.8-74.5%, and for oral therapies reported 10-78% [21,28].…”

Section: Discussionmentioning

confidence: 94%

Persistence and compliance with osteoporosis therapies among postmenopausal women in the UK Clinical Practice Research Datalink

et al. 2019

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Gaining full benefits from osteoporosis medications requires long-term treatment. Investigating the real-world persistence of women receiving osteoporosis medications in the UK, we found that most patients stop treatment within a year. To prevent osteoporotic fragility fractures, long-term treatment persistence must be improved. Introduction Persistence with osteoporosis therapies has historically been poor. To treat this chronic and progressive disease, it is essential that patients receive the full benefit of these medications. We estimated persistence and compliance with osteoporosis therapies in a large sample of postmenopausal women in the UK. Methods Data were obtained from the Clinical Practice Research Datalink for all women aged 50 years and over or women with early menopause, who received at least one prescription in primary care for any licensed osteoporosis therapy between January 1, 2010 and December 31, 2015. Persistence and compliance at 24 months (primary objective) and at 5 years (exploratory objective) were estimated in three patient cohorts: "All Patients," "Naïve Patients," and "Drug-Specific." Results The All Patients cohort included 72,256 women. Persistence with any therapy was 56.1%, 43.6%, 36.4%, and 31.0% at 6, 12, 18, and 24 months, respectively, and 23.2% and 13.1% at 3 years and 5 years, respectively. Patients were generally more persistent and compliant if evaluated from their first exposure to osteoporosis therapy (Naïve Patients cohort). In the drug-specific analysis, 64% of patients receiving denosumab (administered subcutaneously every 6 months) were persistent at 24 months compared with 28% and 23% of those taking oral bisphosphonates and intravenous bisphosphonates, respectively. Conclusions Only about one in three patients who received osteoporosis therapy continued to be on treatment after 2 years. There is a need to improve persistence with osteoporosis therapy, especially for high-risk patients

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Section: Discussionmentioning

confidence: 94%

Persistence and compliance with osteoporosis therapies among postmenopausal women in the UK Clinical Practice Research Datalink

et al. 2019

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“…In fact, a large number of patients reporting a fragility fracture in the placebo and teriparatide groups sustained the traumatic event during the first few weeks of treatment 28,30 and the differences in fracture rates between the two treatment arms were minimal at 12 and 18 months. 9,30,31 Moreover, the observations of both enhanced anabolic effect and lower bone resorption with abaloparatide use compared to teriparatide therapy have also been questioned. 31…”

Section: New Anabolic Drugs: Abaloparatidementioning

confidence: 99%

“…7 Moreover, compliance and persistence to BP therapy are generally poor. 8 Denosumab is an advancement in antiresorptive therapy especially for enhancing adherence and persistence to treatment 9 as well as for a putative stimulation of osteoblastic activity in specific areas of cortical bone, 10 as evidenced by animal studies, but not yet confirmed in humans. 11 Furthermore, the suppression of bone turnover caused by antiresorptive drugs may explain osteonecrosis of the jaw and atypical femoral fractures which can be observed in patients with high-dose or long-term treatment.…”

Section: Introductionmentioning

confidence: 99%

<p>Pharmacological Therapy of Osteoporosis: What’s New?</p>

Iolascon

Moretti

Toro

et al. 2020

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Osteoporosis and fragility fractures are relevant health issues because of their impact in terms of morbidity, mortality, and socioeconomic burden. Despite this alarming scenario, both underdiagnosis and undertreatment are common features of osteoporotic patients, particularly those who have already sustained a fragility fracture. Pharmacotherapy of osteoporosis is the main treatment option for these patients because of strong evidence about the efficacy of available drugs targeting bone metabolism. However, several issues can interfere with the effectiveness of anti-osteoporotic drugs in clinical practice, such as lack of awareness of both healthcare providers and patients, poor adherence to therapy, and safety in long-term treatment. Therefore, new therapeutic strategies have been proposed to overcome these problems, such as sequential therapy or emerging molecules mainly targeting the stimulation of bone formation. In particular, abaloparatide has been demonstrated to reduce major nonvertebral fracture risk compared with both placebo and teriparatide, although the European Medicines Agency (EMA) refused the marketing authorization because the benefits of this drug did not outweigh its risks. On the other side, EMA has recently approved romosozumab, a monoclonal antibody directed against sclerostin and the only available therapeutic option targeting Wnt signaling, as both bone-forming and antiresorptive intervention to treat osteoporosis and fragility fractures.

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“…The receptor activator of nuclear factor-kB ligand (RANKL)/osteoprotegerin (OPG) system is one of the main regulators of bone remodeling (28). Denosumab, a RANKL pathway inhibitor monoclonal antibody, has been widely used in the treatment of osteoporosis (29)(30)(31)(32)(33). Increased osteoblast expression of RANKL has been previously observed in unloading conditions, such as SCI, resulting in an increased RANKL/OPG ratio (34)(35)(36)(37)(38).…”

Section: Denosumabmentioning

confidence: 99%

Spinal Cord Injury as a Model of Bone-Muscle Interactions: Therapeutic Implications From in vitro and in vivo Studies

et al. 2020

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Spinal cord injuries (SCIs) represent a variety of conditions related to the damage of the spinal cord with consequent musculoskeletal repercussions. The bone and muscle tissues share several catabolic pathways that lead to variable degrees of disability in SCI patients. In this review article, we provide a comprehensive characterization of the available treatment options targeting the skeleton and the bone in the setting of SCI. Among the pharmacological intervention, bisphosphonates, anti-sclerostin monoclonal antibodies, hydrogen sulfide, parathyroid hormone, and RANKL pathway inhibitors represent valuable options for treating bone alterations. Loss phenomena at the level of the muscle can be counteracted with testosterone, anabolic-androgenic steroids, and selective androgen receptor modulators. Exercise and physical therapy are valuable strategies to increase bone and muscle mass. Nutritional interventions could enhance SCI treatment, particularly in the setting of synergistic and multidisciplinary interventions, but there are no specific guidelines available to date. The development of multidisciplinary recommendations is required for a proper clinical management of SCI patients.

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Persistence with denosumab therapy in women affected by osteoporosis with fragility fractures: a multicenter observational real practice study in Italy

Cited by 38 publications

References 34 publications

Persistence and compliance with osteoporosis therapies among postmenopausal women in the UK Clinical Practice Research Datalink

Persistence and compliance with osteoporosis therapies among postmenopausal women in the UK Clinical Practice Research Datalink

<p>Pharmacological Therapy of Osteoporosis: What’s New?</p>

Spinal Cord Injury as a Model of Bone-Muscle Interactions: Therapeutic Implications From in vitro and in vivo Studies

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