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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02948881
Recruitment Status : Completed
First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: ibandronate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : August 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis




Primary Outcome Measures :
  1. 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. [ Time Frame: 1 Year ]

Secondary Outcome Measures :
  1. Relationship between biomarkers and changes in bone quality for one year. [ Time Frame: 1 Year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948881


Locations
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United States, California
GSK Investigational Site
Upland, California, United States, 91786
United States, Colorado
GSK Investigational Site
Boulder, Colorado, United States, 80304
GSK Investigational Site
Lakewood, Colorado, United States, 80227
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33143
GSK Investigational Site
Miami, Florida, United States, 33156
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308
GSK Investigational Site
Decatur, Georgia, United States, 30033
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Maine
GSK Investigational Site
Bangor, Maine, United States, 04401
United States, Maryland
GSK Investigational Site
Bathesda, Maryland, United States, 20817
United States, Michigan
GSK Investigational Site
Flint, Michigan, United States, 48532
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87106
United States, New York
GSK Investigational Site
West Haverstraw, New York, United States, 10993
United States, Pennsylvania
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: BON103593
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: BON103593
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: BON103593
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: BON103593
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: BON103593
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: BON103593
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: BON103593
For additional information about this study please refer to the GSK Clinical Study Register

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02948881    
Other Study ID Numbers: BON103593
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
Osteoporosis
bisphosphonates
bone
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs