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Delayed Denosumab Injections and Fracture Risk Among Patients With Osteoporosis : A Population-Based Cohort Study.

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Delaying denosumab injections for osteoporosis increases vertebral fracture risk, especially with longer delays. Ensure timely dosing to maintain treatment effectiveness and prevent bone fractures.

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Area of Science:

  • Orthopedics
  • Pharmacology
  • Epidemiology

Background:

  • Denosumab is an effective osteoporosis treatment.
  • Discontinuation of denosumab leads to a rapid loss of its therapeutic benefits.
  • Understanding the impact of delayed dosing is crucial for patient management.

Purpose of the Study:

  • To assess the fracture risk associated with delayed denosumab injections.
  • To compare fracture risk between patients receiving timely versus delayed denosumab doses.
  • To inform clinical practice regarding denosumab administration schedules.

Main Methods:

  • Population-based cohort study using UK primary care data (2010-2019).
  • Emulation of a hypothetical trial with three dosing intervals: on-time, short delay (4-16 weeks), and long delay (>16 weeks).
  • Primary outcome: composite fracture types at 6 months; secondary outcomes: major osteoporotic, vertebral, hip, and nonvertebral fractures.

Main Results:

  • A total of 2594 patients initiating denosumab were analyzed.
  • Longer delays in denosumab administration were associated with an increased risk of composite fractures.
  • Specifically, a long delay (>16 weeks) showed a hazard ratio of 1.44 for composite fracture and a significantly higher risk for vertebral fractures (HR=3.91).

Conclusions:

  • Delayed denosumab administration, particularly beyond 16 weeks, is linked to an elevated risk of vertebral fractures.
  • Evidence is insufficient to confirm increased fracture risk at other sites with long delays.
  • Maintaining on-time denosumab dosing is recommended to mitigate fracture risk.