Last updated: 11/04/2018 05:43:34
A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
- 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.
- 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.
Inclusion and exclusion 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
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
Status
Study Complete
Location
GSK Investigational Site
Bathesda, Maryland, United States, 20817
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87106
Status
Study Complete
Location
GSK Investigational Site
Upland, California, United States, 91786
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Location
GSK Investigational Site
Boulder, Colorado, United States, 80304
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30308
Status
Study Complete
Location
GSK Investigational Site
West Haverstraw, New York, United States, 10993
Status
Study Complete
Location
GSK Investigational Site
Lakewood, Colorado, United States, 80227
Status
Study Complete
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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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