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Related Experiment Videos

Beyond daily dosing: clinical experience.

C Cooper1

  • 1MRC Epidemiology Resource Centre, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, UK. cc@mrc.soton.ac.uk

Bone
|March 8, 2006
PubMed
Summary
This summary is machine-generated.

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Oral ibandronate effectively treats postmenopausal osteoporosis, reducing vertebral fractures with both daily and intermittent regimens. This study demonstrated the efficacy of beyond-weekly dosing for osteoporosis management.

Area of Science:

  • Endocrinology
  • Bone Metabolism
  • Pharmacology

Background:

  • Osteoporosis poses a significant public health challenge, leading to fractures, disability, and increased mortality.
  • Oral bisphosphonates are a primary treatment for postmenopausal osteoporosis due to their antifracture efficacy.
  • Suboptimal adherence to daily bisphosphonate regimens necessitates exploring less frequent dosing strategies.

Purpose of the Study:

  • To evaluate the efficacy and safety of oral ibandronate in daily and intermittent (dose-free interval >2 months) regimens for postmenopausal osteoporosis.
  • To assess the impact of ibandronate on bone mineral density (BMD), bone turnover, and fracture incidence.
  • To provide proof of concept for bisphosphonate dosing beyond weekly intervals.

Main Methods:

Related Experiment Videos

  • A large Phase III, 3-year study (BONE) involving 2946 women with postmenopausal osteoporosis.
  • Comparison of daily ibandronate (2.5 mg) versus an intermittent regimen (20 mg every other day for 12 doses every 3 months) against placebo.
  • Primary endpoint: vertebral fracture efficacy; secondary endpoints: non-vertebral fractures, BMD changes, bone turnover markers, and safety.

    • Main Results:

    • Both daily and intermittent ibandronate significantly reduced vertebral fracture risk compared to placebo (P < or = 0.0006).
    • Both regimens led to significant increases in lumbar spine and proximal femur BMD and normalized bone turnover.
    • The safety profile of both ibandronate regimens was comparable to placebo, with similar non-vertebral fracture incidence in the overall population.

    Conclusions:

    • Oral ibandronate, administered daily or intermittently, is an effective and well-tolerated treatment for postmenopausal osteoporosis.
    • The BONE study confirmed antifracture efficacy for an intermittent bisphosphonate regimen, supporting dosing beyond weekly intervals.
    • This research paved the way for developing more convenient dosing schedules, such as once-monthly ibandronate.