Last updated: 11/03/2018 10:24:26

Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis

GSK study ID
109393
See study documents
Clinicaltrials.gov ID
NCT00405392
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open-label, multi-centre, randomized study to investigate patient preference on dosing in the once-monthly ibandronate and the once-weekly risedronate in Korean women with postmenopausal osteoporosis. A six-month, two-sequence, and two period crossover study
Trial description: This is a randomized open label, multi-centre study for Korean women with postmenopausal osteoporosis, evaluating the preference for either the once-monthly dosing of ibandronate or the once-weekly dosing of risedronate.
Eligible subjects will be randomised either ibandronate monthly regimen or risedronate weekly regimen.
Treatment period consists of 3 month with ibandronate 150mg and additional 12 week with risedronate 35 mg or vice versa.
After taking the first interventional medicine for 3 months or 12 weeks completely, a subject changes the treatment arm. There is no washout period.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Percentage of participants who prefer the once-monthly dosing of ibandronate to the once-weekly dosing of risedronate

Timeframe: Visit 4 (Week 24)

Secondary outcomes:

Percentage of participants choosing ibandronate or risedronate as their preferred treatment based on convenience of administration

Timeframe: Visit 4 (Week 24)

Mean percent change of serum C-terminal telopeptide (CTx) from Baseline to visit 3 for once-monthly dosing of ibandronate & once-weekly dosing of risedronate

Timeframe: Baseline (Week 0) and Visit 3 (Week 12)

Interventions:
  • Drug: Ibandronate (SB743830HD)
    • Enrollment:
    365
    Primary completion date:
    2008-27-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Osteoporosis, Postmenopausal
    Product
    ibandronic acid
    Collaborators
    Not applicable
    Study date(s)
    March 2007 to May 2008
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Women with postmenopausal osteoporosis diagnosed by DXA scanning, defined by T-score of -2.5 SD at spine or femur.
    • Patients who have never received bisphosphonates therapy (bisphosphonates naive)
    • Inability to stand or sit in the upright position for at least 60 minutes;
    • Hypersensitivity to any component of risedronate and ibandronate;
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Women with postmenopausal osteoporosis diagnosed by DXA scanning, defined by T-score of -2.5 SD at spine or femur.
    • Patients who have never received bisphosphonates therapy (bisphosphonates naive)
    Exclusion criteria:
    • Inability to stand or sit in the upright position for at least 60 minutes;
    • Hypersensitivity to any component of risedronate and ibandronate;
    • Administration of any investigational drug within 30 days preceding the first dose of the study drug;
    • Patient has been on hormone (estrogen) replacement therapy or other osteoporosis medication (e.g. SERMS and calcitonin) within the previous 3 months.
    • Patient has been on systemic corticosteroids therapy for more than 1 month within the past year.
    • Other bone disease except osteoporosis
    • Current medical history of uncontrolled major upper GI disease

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2008-27-05
    Actual study completion date
    2008-27-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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