Last updated: 11/04/2018 05:43:34

A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo

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GSK study ID
BON103593
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Clinicaltrials.gov ID
NCT02948881
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: A one year, parallel, placebo-controlled, double-blind, randomized study to assess the effect of monthly 150mg oral ibandronate dosing versus placebo on bone quality and strength at the proximal femur in women with osteoporosis
Trial description: The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken once monthly versus placebo on bone quality and strength at the hip at one year.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Bone quality and strength at the hip by characterizing changes in trabecular and cortical bone quality using Volumetric Quantitative Computed Tomography (vQCT) and novel imaging analysis methods, including a subset of bone biopsies for one year.

Timeframe: 1 Year

Secondary outcomes:

Relationship between biomarkers and changes in bone quality for one year.

Timeframe: 1 Year

Interventions:
  • Drug: ibandronate
    • Enrollment:
    100
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Osteoporosis
    Product
    ibandronic acid
    Collaborators
    Not applicable
    Study date(s)
    August 2005 to July 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    55 - 80 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Ambulatory, postmenopausal women who are diagnosed with osteoporosis.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Ambulatory, postmenopausal women who are diagnosed with osteoporosis.
    • Must be able to stand or sit upright for at least 60 minutes and swallow a tablet whole. Exclusion criteria:
    • Have been treated with other bisphosphonates or using chronic steroids within the past 6 months.
    • Have a history of major upper GI diseases or have severe kidney dysfunction.
    • Have a spine fracture (identified on x-ray).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Flint, Michigan, United States, 48532
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33143
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Duncansville, Pennsylvania, United States, 16635
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bathesda, Maryland, United States, 20817
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Palm Beach, Florida, United States, 33407
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Albuquerque, New Mexico, United States, 87106
    Status
    Study Complete
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    Showing 1 - 6 of 15 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-17-07

    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

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