OsteoporosisPhase 4NCT02948881
A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo
A Phase 4 study testing ibandronate in people with Osteoporosis, run by GlaxoSmithKline at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- ibandronate
- How many people
- 100 participants
- Where
- 15 sitesUnited States
- Study dates
- Aug 2005to Jul 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
GSK Investigational Site
Albuquerque, New Mexico, 87106
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Bangor, Maine, 04401
GSK Investigational Site
Bathesda, Maryland, 20817
GSK Investigational Site
Boulder, Colorado, 80304
GSK Investigational Site
Decatur, Georgia, 30033
GSK Investigational Site
Duncansville, Pennsylvania, 16635
GSK Investigational Site
Flint, Michigan, 48532
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Lakewood, Colorado, 80227
GSK Investigational Site
Miami, Florida, 33143
GSK Investigational Site
Miami, Florida, 33156
GSK Investigational Site
Upland, California, 91786
GSK Investigational Site
West Haverstraw, New York, 10993
GSK Investigational Site
West Palm Beach, Florida, 33407
About this study
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
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.
- Conditions
- Osteoporosis
- Being tested
- ibandronate
- Keywords
- Osteoporosis, bisphosphonates, bone
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibandronateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year
Secondary outcomes (1)
Relationship between biomarkers and changes in bone quality for one year.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startAug 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948881
- Sponsor's protocol ID
- BON103593
- Status last verified
- Oct 2016
- First submitted
- 27 Oct 2016
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02948881
- Acronym / sponsor ID
- BON103593
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, bisphosphonates, bone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ibandronate | Drug | – |
Primary outcome
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
1 secondary outcome
Relationship between biomarkers and changes in bone quality for one year.
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ibandronate in people with Osteoporosis, run by GlaxoSmithKline at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.