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

NCT ID: NCT02604836

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1711 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postmenopausal Osteoporosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ibandronate

Participants will receive 150 milligrams (mg) of ibandronate as a film-coated tablet once-monthly.

Group Type EXPERIMENTAL

Ibandronate

Intervention Type DRUG

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

Interventions

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Ibandronate

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

Intervention Type DRUG

Other Intervention Names

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Bonviva/Boniva

Eligibility Criteria

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Inclusion Criteria

\- 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

Exclusion Criteria

* 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).
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

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Birmingham, Alabama, United States

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Columbiana, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Montgomery, Alabama, United States

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Chandler, Arizona, United States

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Gilbert, Arizona, United States

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Paradise Valley, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Carlisle, Arkansas, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Pine Bluff, Arkansas, United States

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Rogers, Arkansas, United States

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Searcy, Arkansas, United States

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Sherwood, Arkansas, United States

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Anaheim, California, United States

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Beverly Hills, California, United States

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Laguna Hills, California, United States

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Mission Viejo, California, United States

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Palm Desert, California, United States

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Palo Alto, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Tacoma, California, United States

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Vista, California, United States

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Westlake Village, California, United States

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Colorado Springs, Colorado, United States

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Lakewood, Colorado, United States

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Avon, Connecticut, United States

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Cromwell, Connecticut, United States

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Hamden, Connecticut, United States

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New London, Connecticut, United States

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Waterbury, Connecticut, United States

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Wilmington, Delaware, United States

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Aventura, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Gainesville, Florida, United States

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Longwood, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Palm Bay, Florida, United States

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Palm Harbor, Florida, United States

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Port Orange, Florida, United States

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Sarasota, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Decatur, Georgia, United States

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Rome, Georgia, United States

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Boise, Idaho, United States

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Coeur d'Alene, Idaho, United States

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Champaign, Illinois, United States

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Creve Coeur, Illinois, United States

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Peoria, Illinois, United States

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Evansville, Indiana, United States

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Arkansas City, Kansas, United States

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Newton, Kansas, United States

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Wichita, Kansas, United States

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Natchitoches, Louisiana, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Chelsea, Michigan, United States

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Detroit, Michigan, United States

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Saint Joseph, Michigan, United States

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Chaska, Minnesota, United States

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Jefferson City, Missouri, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Omaha, Nebraska, United States

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Clifton, New Jersey, United States

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Middletown, New Jersey, United States

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New Brunswick, New Jersey, United States

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Princeton, New Jersey, United States

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Brooklyn, New York, United States

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East Syracuse, New York, United States

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New York, New York, United States

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Olean, New York, United States

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Rochester, New York, United States

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Stony Brook, New York, United States

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Durham, North Carolina, United States

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Durham, North Carolina, United States

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Fayetteville, North Carolina, United States

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Morehead City, North Carolina, United States

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Morganton, North Carolina, United States

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Raleigh, North Carolina, United States

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Salisbury, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Grand Forks, North Dakota, United States

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Beachwood, Ohio, United States

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Canfield, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Bala-Cynwyd, Pennsylvania, United States

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Langhorne, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Charleston, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Spartanburg, South Carolina, United States

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Bristol, Tennessee, United States

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Memphis, Tennessee, United States

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Murfreesboro, Tennessee, United States

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Nashville, Tennessee, United States

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Sevierville, Tennessee, United States

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Carrollton, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Denton, Texas, United States

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San Antonio, Texas, United States

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Wichita Falls, Texas, United States

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Norfolk, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Renton, Washington, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

Other Identifiers

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ML18056

Identifier Type: -

Identifier Source: org_study_id