Trial intelligence / Profile preview

Ibandronate vs Alendronate Preference in Osteoporosis

NCT00327990Phase 4

Key facts

Status
Completed
Start
Apr 2005
Primary completion
Dec 2006
Countries
1
Sponsor
GSK
Modality
Small Molecules
Conditions
osteoporosis
01

Overview

Phase 4, randomised, open-label trial of ibandronate in osteoporosis (2 arms), sponsored by GSK. Primary endpoints: Percentage of patients falsely not diagnosed with osteoporosis and Patient preference for once monthly ibandronate or once weekly alendronate. Started Apr 2005; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Ibandronate then Alendronate

    Patients receive monthly Ibandronate first, then switch to weekly Alendronate.

  • Alendronate then Ibandronate

    Patients receive weekly Alendronate first, then switch to monthly Ibandronate.

03

Who it enrols

Women registered with a GP, without a prior history of osteoporosis, who are then screened and diagnosed with osteoporosis.

04

Endpoints

Primary

  • Percentage of patients falsely not diagnosed with osteoporosis

  • Patient preference for once monthly ibandronate or once weekly alendronate

Secondary

  • Safety and tolerance of both ibandronate and alendronate

  • Patient preference in reminder methods

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