Factors associated with high 24-month persistence with denosumab: results of a real-world, non-interventional study of women with postmenopausal osteoporosis in Germany, Austria, Greece, and Belgium

Fahrleitner‐Pammer, Astrid; Παπαϊωάννου, Νικόλαος; Gielen, Evelien; Tepie, Maurille Feudjo; Toffis, C.; Frieling, Isolde; Geusens, Piet; Makras, Polyzois; Boschitsch, Ewald; Callens, J.; Anastasilakis, Athanasios D.; Niedhart, Christopher; Resch, Heinrich; Kalouche-Khalil, L.; Hadji, Peyman

doi:10.1007/s11657-017-0351-2

Cited by 46 publications

(26 citation statements)

References 40 publications

(82 reference statements)

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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: 93%

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: 93%

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

et al. 2019

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“…This duration of treatment is, however, consistent with "real-world" findings showing adherence to Dmab treatment for 2 years in about 50% of patients in most studies, (41)(42)(43)(44)(45) though higher rates have also been reported. (46) In addition, the relatively small number of patients of our study allowed detailed analysis of individual responses, not generally available in large trials, which provided information important for clinical care.…”

Section: Discussionmentioning

confidence: 99%

Zoledronate for the Prevention of Bone Loss in Women Discontinuing Denosumab Treatment. A Prospective 2-Year Clinical Trial

Anastasilakis

Papapoulos

Polyzos

et al. 2019

Journal of Bone and Mineral Research

115

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Cessation of denosumab treatment is associated with increases in bone turnover above baseline values and rapid bone loss. We investigated the efficacy of zoledronate to prevent this bone loss in women with postmenopausal osteoporosis who were treated with denosumab (mean duration 2.2 years) and discontinued treatment after achieving osteopenia. Women were randomized to receive a single 5‐mg infusion of zoledronate (ZOL) (n = 27) or two additional 60‐mg injections of denosumab (Dmab) (n = 30). Both groups were followed for a total period of 24 months. At 24 months lumbar spine–bone mineral density (LS‐BMD) was not different from baseline in the ZOL group, but decreased in the Dmab group by (mean ± SD) 4.82% ± 0.7% (p < 0.001) from the 12‐month value; the difference in BMD changes between the two groups, the primary endpoint of the study, was statistically significant (p = 0.025). Results of femoral neck (FN)‐BMD changes were similar. ZOL infusion was followed by small but significant increases in serum procollagen type 1 N‐terminal propeptide (P1NP) and C‐terminal telopeptide of type 1 collagen (CTX) during the first year and stabilization thereafter. In the Dmab group, bone turnover marker values did not change during the first 12 months but increased significantly at 15 months and in the majority of women these remained elevated at 24 months. Neither baseline nor 12‐month bone turnover marker values were associated with BMD changes in either group of women. In the Dmab group, three patients sustained vertebral fractures (two patients multiple clinical, one patient morphometric) whereas one patient in the ZOL group sustained clinical vertebral fractures 12 months after the infusion. In conclusion, a single intravenous infusion of ZOL given 6 months after the last Dmab injection prevents bone loss for at least 2 years independently of the rate of bone turnover. Follow‐up is recommended, because in a few patients ZOL treatment might not have the expected effect at 2 years. © 2019 American Society for Bone and Mineral Research.

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“…Based on its pharmacokinetics, Dmab at the approved dose of 60 mg is administered subcutaneously every 6 months. This intermittent way of administration renders the agent appealing, especially for older patients with polypharmacy, inability to remain in an upright position for long or impaired memory, and it increases the persistence to treatment (51).…”

Section: Efficacymentioning

confidence: 99%

THERAPY OF ENDOCRINE DISEASE: Denosumab vs bisphosphonates for the treatment of postmenopausal osteoporosis

Anastasilakis

Polyzos

Makras

2018

European Journal of Endocrinology

100

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The most widely used medications for the treatment of osteoporosis are currently bisphosphonates (BPs) and denosumab (Dmab). Both are antiresorptives, thus targeting the osteoclast and inhibiting bone resorption. Dmab achieves greater suppression of bone turnover and greater increases of bone mineral density (BMD) at all skeletal sites, both in naïve and pretreated patients. No superiority on fracture risk reduction has been documented so far. In long-term administration, BPs reach a plateau in BMD response after 2-3 years, especially at the hip, while BMD increases progressively for as long as Dmab is administered. Both BPs and Dmab are generally considered safe, although they have been correlated to rare adverse events, such as osteonecrosis of the jaw and atypical femoral fractures. Dmab should be preferred in patients with impaired renal function. BPs are embedded in the bone, from which they are slowly released during bone remodeling, therefore continuing to act for years after their discontinuation. In contrast, Dmab discontinuation fully and rapidly reverses its effects on bone markers and BMD and increases the risk for fractures; therefore, Dmab discontinuation should be discouraged, especially in previously treatment-naïve patients, regardless of the conventional fracture risk. In case of discontinuation, other treatment, mainly BPs, should immediately follow, although the optimal sequential treatment strategy is yet to be defined. Combination of teriparatide with Dmab or zoledronic acid, but not alendronate, provides increased BMD gains at all sites. In conclusion, both BPs and Dmab are safe and efficient therapeutic options although their particularities should be carefully considered in an individual basis.

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Factors associated with high 24-month persistence with denosumab: results of a real-world, non-interventional study of women with postmenopausal osteoporosis in Germany, Austria, Greece, and Belgium

Cited by 46 publications

References 40 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

Zoledronate for the Prevention of Bone Loss in Women Discontinuing Denosumab Treatment. A Prospective 2-Year Clinical Trial

THERAPY OF ENDOCRINE DISEASE: Denosumab vs bisphosphonates for the treatment of postmenopausal osteoporosis

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