Postmenopausal OsteoporosisPhase 4NCT02598440
A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis
A Phase 4 study testing Alendronate and Ibandronate in people with Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 54 sites in United States.
Trial summary
This study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 individuals. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Alendronate and Ibandronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 54 sitesUnited States
- Study dates
- Mar 2004to May 2005
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ambulatory women
- Diagnosis of post-menopausal osteoporosis
- Women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry
Who cannot join
- Inability to stand or sit in the upright position for greater than or equal to 60 minutes
- Allergy to bisphosphonates;
- Previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
United States54 sites
Study site
Augusta, Georgia, 30904
Study site
Aventura, Florida, 33180
Study site
Baltimore, Maryland, 21209
Study site
Bangor, Maine, 04401
Study site
Chicago, Illinois, 60612
Study site
Cromwell, Connecticut, 06416
Study site
Dallas, Texas, 75234
Study site
Decatur, Georgia, 30033
Study site
Denver, Colorado, 80202
Study site
Des Moines, Iowa, 50314
Study site
Duncansville, Pennsylvania, 16635
Study site
Erie, Pennsylvania, 16502
Study site
Erie, Pennsylvania, 16506
Study site
Eugene, Oregon, 97401
Study site
Florissant, Missouri, 63031
Study site
Houston, Texas, 77024
Study site
Huntsville, Alabama, 35801
Study site
Indianapolis, Indiana, 46202
Study site
Laguna Woods, California, 92653
Study site
Madison, Wisconsin, 53705
Study site
Miami, Florida, 33176
Study site
Mission Viejo, California, 92691
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Nashville, Tennessee, 37203
Study site
Newark, Delaware, 19713
Study site
Newport News, Virginia, 23602
Study site
Oceanside, California, 92056
Study site
Orchard Park, New York, 14127
Study site
Pembroke Pines, Florida, 33024
Study site
Philadelphia, Pennsylvania, 19114
Study site
Philadelphia, Pennsylvania, 19148
Study site
Phoenix, Arizona, 85006
Study site
Princeton, New Jersey, 08540
Study site
Raleigh, North Carolina, 27609
Study site
Reno, Nevada, 89502
Study site
Richmond, Virginia, 23235
Study site
San Diego, California, 92103-6204
Study site
San Diego, California, 92108
Study site
Santa Clarita, California, 91321
Study site
Seattle, Washington, 98105
Study site
Seattle, Washington, 98144
Study site
South Bend, Indiana, 46601
Study site
St Louis, Missouri, 63128
Study site
Tampa, Florida, 33614
Study site
Tempe, Arizona, 85282
Study site
Toms River, New Jersey, 08753
Study site
Upland, California, 91786
Study site
Vista, California, 92084
Study site
Warwick, Rhode Island, 02886
Study site
Waterbury, Connecticut, 06708
Study site
West Palm Beach, Florida, 33409
Study site
Wichita, Kansas, 67207
Study site
Worcester, Massachusetts, 01610
Study site
Wyomissing, Pennsylvania, 19610
About this study
Official title: A Randomized, Open-Label, Muti-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once-Monthly Ibandronate and Once-Weekly Alendronate. A Six Month, Two-Sequence, and Two-Period Crossover Study
This study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 individuals.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Alendronate, Ibandronate
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
Participants wil receive once-weekly oral alendronate (70 mg tablet)
IbandronateDrug
Also called Bonviva
Participants wil receive once-monthly oral ibandronate (150 mg tablet)
| Study group | Role | What they receive |
|---|---|---|
| Group A: Ibandronate Then Alendronate | Experimental | Participants wil receive once-monthly oral ibandronate (150 mg tablet) for 3 months followed by and once-weekly oral alendronate (70 mg tablet) in crossover design for 12 weeks. Receives: Drug: Alendronate; Drug: Ibandronate |
| Group B: Alendronate Then Ibandronate | Experimental | Participants will receive once-weekly oral alendronate (70 mg tablet) for 12 weeks followed by once-monthly oral ibandronate (150 mg tablet) for 3 months. Receives: Drug: Alendronate; Drug: Ibandronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate
Measured: Up to 6 months
Secondary outcomes (2)
Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate.
Measured: Up to 6 months
Incidence of adverse events
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startMar 2004
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598440
- Sponsor's protocol ID
- MA17843
- Status last verified
- Nov 2016
- First submitted
- 4 Nov 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Muti-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once-Monthly Ibandronate and Once-Weekly Alendronate. A Six Month, Two-Sequence, and Two-Period Crossover Study
- ClinicalTrials.gov ID
- NCT02598440
- Acronym / sponsor ID
- MA17843
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 5 Nov 2015 (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.
This study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Ibandronate Then Alendronate | Experimental | Drug: Alendronate, Drug: IbandronateParticipants wil receive once-monthly oral ibandronate (150 mg tablet) for 3 months followed by and once-weekly oral alendronate (70 mg tablet) in crossover design for 12 weeks. |
| Group B: Alendronate Then Ibandronate | Experimental | Drug: Alendronate, Drug: IbandronateParticipants will receive once-weekly oral alendronate (70 mg tablet) for 12 weeks followed by once-monthly oral ibandronate (150 mg tablet) for 3 months. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Ambulatory women
- Diagnosis of post-menopausal osteoporosis
- Women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry
Key exclusion criteria (3 listed)
- Inability to stand or sit in the upright position for greater than or equal to 60 minutes
- Allergy to bisphosphonates;
- Previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry
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 |
|---|---|---|
| AlendronateParticipants wil receive once-weekly oral alendronate (70 mg tablet) | Drug | Group A: Ibandronate Then Alendronate, Group B: Alendronate Then Ibandronate |
| IbandronateAlso: BonvivaParticipants wil receive once-monthly oral ibandronate (150 mg tablet) | Drug | Group A: Ibandronate Then Alendronate, Group B: Alendronate Then Ibandronate |
Primary outcome
Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate
Time frame: Up to 6 months
2 secondary outcomes
Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate.
Time frame: Up to 6 months
Incidence of adverse events
Time frame: Up to approximately 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 2 Nov 2016.
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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.
Clinical Trials study chair
Hoffmann-La Roche
54 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 Alendronate and Ibandronate in people with Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 54 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 3 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 2 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 54 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?
Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate (time frame: Up to 6 months). 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 2 Nov 2016.