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

November 1, 2016 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1711

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
      • Columbiana, Alabama, United States, 35051
      • Huntsville, Alabama, United States, 35801
      • Mobile, Alabama, United States, 36608
      • Montgomery, Alabama, United States, 36111
    • Arizona
      • Chandler, Arizona, United States, 85225
      • Gilbert, Arizona, United States, 85295
      • Paradise Valley, Arizona, United States, 85253
      • Phoenix, Arizona, United States, 85014
      • Phoenix, Arizona, United States, 85006
      • Tempe, Arizona, United States, 85282
      • Tucson, Arizona, United States, 85712
    • Arkansas
      • Carlisle, Arkansas, United States, 72024
      • Jonesboro, Arkansas, United States, 72401
      • Little Rock, Arkansas, United States, 72205
      • Pine Bluff, Arkansas, United States, 71603
      • Rogers, Arkansas, United States, 72756
      • Searcy, Arkansas, United States, 72143
      • Sherwood, Arkansas, United States, 72120
    • California
      • Anaheim, California, United States, 92801
      • Beverly Hills, California, United States, 90211
      • Laguna Hills, California, United States, 92653
      • Mission Viejo, California, United States, 92691
      • Palm Desert, California, United States, 92260
      • Palo Alto, California, United States, 94304
      • Sacramento, California, United States, 95825
      • San Diego, California, United States, 92128
      • Tacoma, California, United States, 98405
      • Vista, California, United States, 92083
      • Westlake Village, California, United States, 91361
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
      • Lakewood, Colorado, United States, 80260
    • Connecticut
      • Avon, Connecticut, United States, 06001
      • Cromwell, Connecticut, United States, 06416
      • Hamden, Connecticut, United States, 06518
      • New London, Connecticut, United States, 06320
      • Waterbury, Connecticut, United States, 06708
    • Delaware
      • Wilmington, Delaware, United States, 19805
    • Florida
      • Aventura, Florida, United States, 33180
      • Clearwater, Florida, United States, 33761
      • Deland, Florida, United States, 32720
      • Fort Myers, Florida, United States, 33916
      • Gainesville, Florida, United States, 32607
      • Gainesville, Florida, United States, 32605
      • Longwood, Florida, United States, 32779
      • Melbourne, Florida, United States, 32901
      • Miami, Florida, United States, 33186
      • Ocala, Florida, United States, 34471
      • Palm Bay, Florida, United States, 32905
      • Palm Harbor, Florida, United States, 34684
      • Port Orange, Florida, United States, 32127
      • Sarasota, Florida, United States, 34239
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Atlanta, Georgia, United States, 30309
      • Augusta, Georgia, United States, 30904
      • Decatur, Georgia, United States, 30033
      • Rome, Georgia, United States, 30165
    • Idaho
      • Boise, Idaho, United States, 83712
      • Coeur D'alene, Idaho, United States, 83814
    • Illinois
      • Champaign, Illinois, United States, 61820
      • Creve Coeur, Illinois, United States, 61610
      • Peoria, Illinois, United States, 61615
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Kansas
      • Arkansas City, Kansas, United States, 67005
      • Newton, Kansas, United States, 67114
      • Wichita, Kansas, United States, 67207
    • Louisiana
      • Natchitoches, Louisiana, United States, 71457
      • New Orleans, Louisiana, United States, 70119
    • Maryland
      • Baltimore, Maryland, United States, 21204
      • Bethesda, Maryland, United States, 20817
    • Michigan
      • Chelsea, Michigan, United States, 48118
      • Detroit, Michigan, United States, 48202
      • St Joseph, Michigan, United States, 49085
    • Minnesota
      • Chaska, Minnesota, United States, 55318
    • Missouri
      • Jefferson City, Missouri, United States, 65109
      • Kansas City, Missouri, United States, 64114
      • Kansas City, Missouri, United States, 64108
      • Saint Louis, Missouri, United States, 63128
      • St Louis, Missouri, United States, 63117
      • St Louis, Missouri, United States, 63110
      • St Louis, Missouri, United States, 63141
    • Montana
      • Billings, Montana, United States, 59101
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New Jersey
      • Clifton, New Jersey, United States, 07012
      • Middletown, New Jersey, United States, 07748
      • New Brunswick, New Jersey, United States, 08901
      • Princeton, New Jersey, United States, 08540
    • New York
      • Brooklyn, New York, United States, 11201
      • East Syracuse, New York, United States, 13057
      • New York, New York, United States, 10011
      • Olean, New York, United States, 14760
      • Rochester, New York, United States, 14609
      • Stony Brook, New York, United States, 11794-8161
    • North Carolina
      • Durham, North Carolina, United States, 27705
      • Durham, North Carolina, United States, 27704
      • Fayetteville, North Carolina, United States, 28304
      • Morehead City, North Carolina, United States, 28557
      • Morganton, North Carolina, United States, 28655
      • Raleigh, North Carolina, United States, 27609
      • Salisbury, North Carolina, United States, 28144
      • Wilmington, North Carolina, United States, 28401
      • Winston-salem, North Carolina, United States, 27103
    • North Dakota
      • Fargo, North Dakota, United States, 58103
      • Grand Forks, North Dakota, United States, 58201
    • Ohio
      • Beachwood, Ohio, United States, 44122
      • Canfield, Ohio, United States, 44406
      • Cincinnati, Ohio, United States, 45246
      • Columbus, Ohio, United States, 43213
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
      • Tulsa, Oklahoma, United States, 74104
    • Oregon
      • Medford, Oregon, United States, 97504
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
      • Langhorne, Pennsylvania, United States, 19047
      • Philadelphia, Pennsylvania, United States, 19114
      • Philadelphia, Pennsylvania, United States, 19131
      • Wyomissing, Pennsylvania, United States, 19610
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Mount Pleasant, South Carolina, United States, 29464
      • Spartanburg, South Carolina, United States, 29307
    • Tennessee
      • Bristol, Tennessee, United States, 37620
      • Memphis, Tennessee, United States, 38103
      • Murfreesboro, Tennessee, United States, 37130
      • Nashville, Tennessee, United States, 37203
      • Sevierville, Tennessee, United States, 37862
    • Texas
      • Carrollton, Texas, United States, 75010
      • Corpus Christi, Texas, United States, 78414
      • Dallas, Texas, United States, 75231
      • Denton, Texas, United States, 76210
      • San Antonio, Texas, United States, 78229
      • Wichita Falls, Texas, United States, 76309
    • Virginia
      • Norfolk, Virginia, United States, 23502
      • Norfolk, Virginia, United States, 23507-1912
      • Richmond, Virginia, United States, 23294
      • Richmond, Virginia, United States, 23226
    • Washington
      • Renton, Washington, United States, 98055
      • Seattle, Washington, United States, 98105
      • Seattle, Washington, United States, 98144
      • Spokane, Washington, United States, 99207
      • Tacoma, Washington, United States, 98405
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
      • Milwaukee, Wisconsin, United States, 53209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibandronate
Participants will receive 150 milligrams (mg) of ibandronate as a film-coated tablet once-monthly.
Drug: Ibandronate
Film-coated oral ibandronate tablet (150 mg) once-monthly
Other Names:
  • Bonviva/Boniva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 30 days prior to baseline visit
Part B: Number of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate
Time Frame: 6 months
6 months
Part B: Percentage of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Part B: Percentage of eligible weekly biphosphonate users at screening who elect to enter Part B
Time Frame: Screening visit
Screening visit
Part B: Percentage of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate
Time Frame: 6 months
6 months
Part B: Percentage of participants who report preference to monthly ibandronate or weekly alendronate or risedronate
Time Frame: 6 months
6 months
Part B: Percentage of participants who have greater than or equal to (>=) 80 percent (%) compliance
Time Frame: 6 months
6 months
Part B: Percentage of participants who report an improvement in the gastrointestinal (GI) symptoms
Time Frame: 6 months
6 months
Part B: Percentage of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)
Time Frame: 6 months
6 months
Part B: Individual Domain scores from Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)
Time Frame: Baseline and 6 months
Baseline and 6 months
Part B: Number of eligible weekly biphosphonate users at screening who elect to enter Part B
Time Frame: Screening Visit
Screening Visit
Part B: Number of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate
Time Frame: 6 months
6 months
Part B: Number of participants who report preference to monthly ibandronate or weekly alendronate or risedronate
Time Frame: 6 months
6 months
Part B: Number of participants who have >= 80% compliance
Time Frame: 6 months
6 months
Part B: Number of participants who report an improvement in the GI symptoms
Time Frame: 6 months
6 months
Part B: Number of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML18056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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