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Postmenopausal OsteoporosisPhase 4NCT02604836

A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia

A Phase 4 study testing Ibandronate in people with Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 142 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will investigate participant satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Postmenopausal Osteoporosis
What is being tested?
Ibandronate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,711 participants
Where
142 sitesUnited States
Study dates
Jun 2004to Apr 2006
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

  • Women who had been receiving once-weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis for greater than or equal to (>=) 3 months

Who cannot join

  • Inability to stand or sit upright for >=60 minutes
  • Hypersensitivity to bisphosphonates
  • Inability to swallow a tablet whole
  • Malignant disease diagnosed within previous 10 years (except resected basal cell cancer).

Trial locations and contacts

142 sites in 1 country.

142 sites in 1 country

United States142 sites

  • Study site

    Anaheim, California, 92801

  • Study site

    Arkansas City, Kansas, 67005

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Augusta, Georgia, 30904

  • Study site

    Aventura, Florida, 33180

  • Study site

    Avon, Connecticut, 06001

  • Study site

    Bala-Cynwyd, Pennsylvania, 19004

  • Study site

    Baltimore, Maryland, 21204

  • Study site

    Beachwood, Ohio, 44122

  • Study site

    Bethesda, Maryland, 20817

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Billings, Montana, 59101

  • Study site

    Birmingham, Alabama, 35235

  • Study site

    Boise, Idaho, 83712

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Brooklyn, New York, 11201

  • Study site

    Canfield, Ohio, 44406

  • Study site

    Carlisle, Arkansas, 72024

  • Study site

    Carrollton, Texas, 75010

  • Study site

    Champaign, Illinois, 61820

  • Study site

    Chandler, Arizona, 85225

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Chaska, Minnesota, 55318

  • Study site

    Chelsea, Michigan, 48118

  • Study site

    Cincinnati, Ohio, 45246

  • Study site

    Clearwater, Florida, 33761

  • Study site

    Clifton, New Jersey, 07012

  • Study site

    Coeur d'Alene, Idaho, 83814

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Columbiana, Alabama, 35051

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Corpus Christi, Texas, 78414

  • Study site

    Creve Coeur, Illinois, 61610

  • Study site

    Cromwell, Connecticut, 06416

  • Study site

    Dallas, Texas, 75231

  • Study site

    Decatur, Georgia, 30033

  • Study site

    DeLand, Florida, 32720

  • Study site

    Denton, Texas, 76210

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Durham, North Carolina, 27704

  • Study site

    Durham, North Carolina, 27705

  • Study site

    East Syracuse, New York, 13057

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Fayetteville, North Carolina, 28304

  • Study site

    Fort Myers, Florida, 33916

  • Study site

    Gainesville, Florida, 32605

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Gilbert, Arizona, 85295

  • Study site

    Grand Forks, North Dakota, 58201

  • Study site

    Hamden, Connecticut, 06518

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Jefferson City, Missouri, 65109

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Kansas City, Missouri, 64108

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Lakewood, Colorado, 80260

  • Study site

    Langhorne, Pennsylvania, 19047

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Longwood, Florida, 32779

  • Study site

    Madison, Wisconsin, 53705

  • Study site

    Medford, Oregon, 97504

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Memphis, Tennessee, 38103

  • Study site

    Miami, Florida, 33186

  • Study site

    Middletown, New Jersey, 07748

  • Study site

    Milwaukee, Wisconsin, 53209

  • Study site

    Mission Viejo, California, 92691

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Montgomery, Alabama, 36111

  • Study site

    Morehead City, North Carolina, 28557

  • Study site

    Morganton, North Carolina, 28655

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Murfreesboro, Tennessee, 37130

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Natchitoches, Louisiana, 71457

  • Study site

    New Brunswick, New Jersey, 08901

  • Study site

    New London, Connecticut, 06320

  • Study site

    New Orleans, Louisiana, 70119

  • Study site

    New York, New York, 10011

  • Study site

    Newton, Kansas, 67114

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Norfolk, Virginia, 23507-1912

  • Study site

    Ocala, Florida, 34471

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Olean, New York, 14760

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Palm Bay, Florida, 32905

  • Study site

    Palm Desert, California, 92260

  • Study site

    Palm Harbor, Florida, 34684

  • Study site

    Palo Alto, California, 94304

  • Study site

    Paradise Valley, Arizona, 85253

  • Study site

    Peoria, Illinois, 61615

  • Study site

    Philadelphia, Pennsylvania, 19114

  • Study site

    Philadelphia, Pennsylvania, 19131

  • Study site

    Phoenix, Arizona, 85006

  • Study site

    Phoenix, Arizona, 85014

  • Study site

    Pine Bluff, Arkansas, 71603

  • Study site

    Port Orange, Florida, 32127

  • Study site

    Portland, Oregon, 97210

  • Study site

    Princeton, New Jersey, 08540

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Renton, Washington, 98055

  • Study site

    Richmond, Virginia, 23226

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Rochester, New York, 14609

  • Study site

    Rogers, Arkansas, 72756

  • Study site

    Rome, Georgia, 30165

  • Study site

    Sacramento, California, 95825

  • Study site

    Saint Joseph, Michigan, 49085

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92128

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Searcy, Arkansas, 72143

  • Study site

    Seattle, Washington, 98105

  • Study site

    Seattle, Washington, 98144

  • Study site

    Sevierville, Tennessee, 37862

  • Study site

    Sherwood, Arkansas, 72120

  • Study site

    Spartanburg, South Carolina, 29307

  • Study site

    Spokane, Washington, 99207

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St Louis, Missouri, 63117

  • Study site

    St Louis, Missouri, 63128

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Stony Brook, New York, 11794-8161

  • Study site

    Tacoma, California, 98405

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Tempe, Arizona, 85282

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Tulsa, Oklahoma, 74104

  • Study site

    Vista, California, 92083

  • Study site

    Waterbury, Connecticut, 06708

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    Westlake Village, California, 91361

  • Study site

    Wichita, Kansas, 67207

  • Study site

    Wichita Falls, Texas, 76309

  • Study site

    Wilmington, Delaware, 19805

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Wyomissing, Pennsylvania, 19610

Other trials in United States

About this study

Official title: A Prospective, Open-Label, Multi-Center, Two-Part Study to Investigate Patient Satisfaction With Monthly Dosed Ibandronate Therapy in Women With Post-Menopausal Osteoporosis or Osteopenia Transitioned From Once-Weekly Alendronate or Risendronate

This study will investigate participant satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on study treatment is 6 months, and the target sample size is 1776 individuals.

Being tested
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.

  • IbandronateDrug

    Also called Bonviva/Boniva

    Film-coated oral ibandronate tablet (150 mg) once-monthly

Study groups in NCT02604836
Study groupRoleWhat they receive
IbandronateExperimentalParticipants will receive 150 milligrams (mg) of ibandronate as a film-coated tablet once-monthly.
Receives: Drug: Ibandronate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number of participants who currently use weekly biphosphonate who answer "yes" to any of the questions in Candidate Identification Questionnaire (CIQ)

    Measured: Up to 30 days prior to baseline visit

  2. Part B: Number of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate

    Measured: 6 months

  3. Part B: Percentage of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate

    Measured: 6 months

Secondary outcomes (13)

  1. Part B: Percentage of eligible weekly biphosphonate users at screening who elect to enter Part B

    Measured: Screening visit

  2. Part B: Percentage of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate

    Measured: 6 months

  3. Part B: Percentage of participants who report preference to monthly ibandronate or weekly alendronate or risedronate

    Measured: 6 months

  4. Part B: Percentage of participants who have greater than or equal to (>=) 80 percent (%) compliance

    Measured: 6 months

  5. Part B: Percentage of participants who report an improvement in the gastrointestinal (GI) symptoms

    Measured: 6 months

  6. Part B: Percentage of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)

    Measured: 6 months

  7. Part B: Individual Domain scores from Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)

    Measured: Baseline and 6 months

  8. Part B: Number of eligible weekly biphosphonate users at screening who elect to enter Part B

    Measured: Screening Visit

  9. Part B: Number of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate

    Measured: 6 months

  10. Part B: Number of participants who report preference to monthly ibandronate or weekly alendronate or risedronate

    Measured: 6 months

  11. Part B: Number of participants who have >= 80% compliance

    Measured: 6 months

  12. Part B: Number of participants who report an improvement in the GI symptoms

    Measured: 6 months

  13. Part B: Number of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2015 (estimated)
  2. Study startJun 2004
  3. Primary completionApr 2006
  4. Study completionApr 2006

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,711 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02604836
Sponsor's protocol ID
ML18056
Status last verified
Nov 2016
First submitted
6 Nov 2015
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ibandronate in people with Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 142 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 1 inclusion and 4 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 142 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?

Part A: Number of participants who currently use weekly biphosphonate who answer "yes" to any of the questions in Candidate Identification Questionnaire (CIQ) (time frame: Up to 30 days prior to baseline visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02604836.

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; AzTrials last refreshed its copy on 7 Nov 2026.

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