Delayed Denosumab Injections and Fracture Risk Among Patients With Osteoporosis

Lyu, Houchen; Yoshida, Kazuki; Zhao, Sizheng Steven; Wei, Jie; Zeng, Chao; Tedeschi, Sara K.; Leder, Benjamin Z.; Lei, Guanghua; Tang, Peifu; Solomon, Daniel H.

doi:10.7326/m20-0882

Cited by 75 publications

(64 citation statements)

References 44 publications

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“…Since the study’s primary aim was to evaluate the adherence of patients to the first lockdown phase during the ongoing COVID-19 pandemic, it was not designed to evaluate the interactions between adherence and risk of rebound fracture after interruption of denosumab therapy. Though conflicting evidence exists as to how long an injection of denosumab would have to be delayed before fracture risk increases [ 33 ], the general recommendation as mentioned previously is that injections not be delayed by more than 7 months after the previous injection [ 7 ]. The findings from a preliminary analysis that we subsequently performed showed that, overall, fractures on follow-up were less likely to occur in patients who were adherent to their second dose of denosumab at 6 months (with an allowable delay of 4 weeks).…”

Section: Discussionmentioning

confidence: 99%

Adherence to dosing schedule of denosumab therapy for osteoporosis during COVID-19 lockdown: an electronic medical record and pharmacy claims database study from Asia

et al. 2021

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Section: Discussionmentioning

confidence: 99%

Adherence to dosing schedule of denosumab therapy for osteoporosis during COVID-19 lockdown: an electronic medical record and pharmacy claims database study from Asia

et al. 2021

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“…Eine weitere wichtige Nachricht aus der Osteologie ist, dass Denosumab nicht plötzlich aus-oder abrupt abgesetzt werden darf. Das ergab eine große populationsbasierte Kohortenstudie aus Großbritannien [ 41 ].…”

Section: Endokrinologieunclassified

Diabetes Update 2021

Scherbaum

2021

Diabetologe

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“…Thus, while fewer patients managed to refill denosumab within a After medication discontinuation, patients were discontinued from the study and were no longer followed 30 days, most achieved refill within 60 days. A recent observational study in 2594 patients in the UK showed that delays of less than 4 months in receiving denosumab were not associated with increased fracture risk, while delays of greater than 4 months increased fracture risk [26]. With bisphosphonates however, much shorter gaps had an impact on fracture risk: in a claims-based study of 35,537 patients, those who achieved refills of bisphosphonate within 30 days had 23-45% lower fracture risk [15].…”

Section: Discussionmentioning

confidence: 99%

Persistence with Denosumab in Women at High Risk of Fracture in Bulgaria

Monov

Nestorova²,

Velkova

et al. 2021

Rheumatol Ther

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Introduction Post-menopausal women with osteoporosis > 70 years of age at high risk of fracture urgently require treatment for fracture prevention. Moreover, persistence with osteoporosis therapy is critical for real-world effectiveness. We estimated persistence with denosumab in older women at high fracture risk in clinical practice in Bulgaria. Methods Eligible participants were post-menopausal women, > 70 years of age, diagnosed with osteoporosis ( T -score ≤ − 2.5) and at high risk of fracture (≥ 3% for hip and ≥ 20% for major osteoporotic fracture) who received at least one denosumab injection before enrollment. Planned follow-up was 24 months. The primary endpoint was persistence to denosumab at 12, 18, and 24 months (defined as receiving all denosumab injections within 6 months ± 60 days of the previous injection). Results 250 women were enrolled across 12 Bulgarian endocrinology/rheumatology practices; median follow up, 736 days. Mean (SD) age was 75.8 (4.2) years; mean (SD) FRAX ® was 13.1 (8.6) for hip and 26.1 (9.5) for major osteoporotic fracture; 47 (18.8%) women had prior osteoporosis therapy and 104 (41.6%) had prior fracture. Denosumab persistence was high: 98.0%, 92.4%, and 84.4% at 12, 18, and 24 months, respectively. A total of 42 (16.8%) women discontinued denosumab during follow-up, mostly for financial reasons [25/42 (59.5%)] or loss to follow-up [8/42 (19.0%)]. After 24 months of denosumab treatment, BMD T -score improvement to the range of osteopenia (− 2.5 ≤ T < − 1.5) was achieved by 42.4% at the femoral neck, 23.6% at the lumbar spine, and 49.2% at the total hip; complete recovery ( T -score ≥ − 1.5) was observed in 9.0%, 26.4%, and 23.0% respectively. New fracture was reported in 5 patients (2%). Conclusions Even in an elderly population, persistence with denosumab was high despite the challenge imposed by the 50% co-pay in Bulgaria. Trial Registration Bulgarian Drug Agency, №HИП-0009 (registered 28.06.2017); Central Ethics Commission: №КИ-41 (registered 16.05.2017) Supplementary Information The online version contains supplementary material available at 10.1007/s40744-021-00282-3.

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Delayed Denosumab Injections and Fracture Risk Among Patients With Osteoporosis

Cited by 75 publications

References 44 publications

Adherence to dosing schedule of denosumab therapy for osteoporosis during COVID-19 lockdown: an electronic medical record and pharmacy claims database study from Asia

Adherence to dosing schedule of denosumab therapy for osteoporosis during COVID-19 lockdown: an electronic medical record and pharmacy claims database study from Asia

Diabetes Update 2021

Persistence with Denosumab in Women at High Risk of Fracture in Bulgaria

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