OsteoporosisPhase 4NCT00148915
A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo
A Phase 4 study testing ibandronate in people with Osteoporosis, run by Hoffmann-La Roche at 14 sites in United States.
Trial summary
The purpose of this randomized, double-blind, placebo-controlled study is to estimate the effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality and strength at the proximal femur 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 14 sitesUnited States
- Study dates
- Aug 2005to Aug 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 between the age of 55 to 80 years diagnosed with osteoporosis
- BMD T-Score less than or equal to (<=) -2.0 at total spine or total femur or total neck, and BMD T-score greater than or equal to (>=) -5.0 at all 3 sites
Who cannot join
- Have been treated with other bisphosphonates or using chronic steroids within the past 6 months
- Have a history of major upper gastrointestinal (GI) diseases or have severe kidney dysfunction
- Have a spine fracture (identified on X-ray)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 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
About this study
Official title: A One Year, Parallel, Placebo-controlled, Double-blind, Randomized Study to Assess the Effect of Monthly 150 mg Oral Ibandronate Dosing Versus Placebo on Bone Quality and Strength at the Proximal Femur in Women With Osteoporosis
The purpose of this randomized, double-blind, placebo-controlled study is to estimate the effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality and strength at the proximal femur at one year.
- Conditions
- Osteoporosis
- Being tested
- ibandronate, Placebo
- 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
Also called Boniva
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Ibandronate | Experimental | Participants will receive 150 milligrams (mg) ibandronate tablet orally once monthly for one year. Receives: Drug: ibandronate |
| Placebo | Placebo comparator | Participants will receive ibandronate matched placebo tablet orally once monthly for one year. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change in integral (cortical and trabecular bone compartments combined) hip bone mineral density (BMD) as determined by Volumetric Quantitative Computed Tomography (vQCT) at one year
Measured: Year 1
Secondary outcomes (8)
Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year
Measured: Year 1
Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans
Measured: Year 1
Hip geometry assessed by cross-sectional dimensions of hip using vQCT
Measured: Year 1
Finite element composition of hip and spine to estimate hip and spine strength
Measured: Year 1
Hip geometry assessed by cross-sectional dimensions of hip using DXA
Measured: Year 1
Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality
Measured: Year 1
Change from baseline for serum-C-terminal cross-linking telopeptide of Type I collagen (Serum-CTX)
Measured: Months 3, 6, 9, and 12
Change from baseline for bone-specific alkaline phosphatase (Bone ALP)
Measured: Months 3, 6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionAug 2007
- Study completionAug 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 Hoffmann-La RocheThe 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
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- HoffmannLaRoche Clinical Trials, MD, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148915
- Sponsor's protocol ID
- BON103593
- Status last verified
- Nov 2016
- First submitted
- 6 Sep 2005
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 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 150 mg Oral Ibandronate Dosing Versus Placebo on Bone Quality and Strength at the Proximal Femur in Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT00148915
- Acronym / sponsor ID
- BON103593
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, bisphosphonates, bone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 8 Sep 2005 (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 randomized, double-blind, placebo-controlled study is to estimate the effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality and strength at the proximal femur at one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibandronate | Experimental | Drug: ibandronateParticipants will receive 150 milligrams (mg) ibandronate tablet orally once monthly for one year. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive ibandronate matched placebo tablet orally once monthly for one year. |
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 between the age of 55 to 80 years diagnosed with osteoporosis
- BMD T-Score less than or equal to (<=) -2.0 at total spine or total femur or total neck, and BMD T-score greater than or equal to (>=) -5.0 at all 3 sites
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 gastrointestinal (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 |
|---|---|---|
| ibandronateAlso: Boniva | Drug | Ibandronate |
| Placebomatching placebo | Drug | Placebo |
Primary outcome
Mean percent change in integral (cortical and trabecular bone compartments combined) hip bone mineral density (BMD) as determined by Volumetric Quantitative Computed Tomography (vQCT) at one year
Time frame: Year 1
8 secondary outcomes
Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year
Time frame: Year 1
Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans
Time frame: Year 1
Hip geometry assessed by cross-sectional dimensions of hip using vQCT
Time frame: Year 1
Finite element composition of hip and spine to estimate hip and spine strength
Time frame: Year 1
Hip geometry assessed by cross-sectional dimensions of hip using DXA
Time frame: Year 1
Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality
Time frame: Year 1
Change from baseline for serum-C-terminal cross-linking telopeptide of Type I collagen (Serum-CTX)
Time frame: Months 3, 6, 9, and 12
Change from baseline for bone-specific alkaline phosphatase (Bone ALP)
Time frame: Months 3, 6, 9, and 12
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 8 Nov 2016.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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.
HoffmannLaRoche Clinical Trials, MD study director
Hoffmann-La Roche
14 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 Hoffmann-La Roche at 14 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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. Some participants in this study may receive a placebo. 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?
Mean percent change in integral (cortical and trabecular bone compartments combined) hip bone mineral density (BMD) as determined by Volumetric Quantitative Computed Tomography (vQCT) at one year (time frame: Year 1). 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 8 Nov 2016.