A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis

November 1, 2016 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

341

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
      • Huntsville, Alabama, United States, 35801
    • Arizona
      • Phoenix, Arizona, United States, 85006
      • Tempe, Arizona, United States, 85282
    • California
      • Laguna Woods, California, United States, 92653
      • Mission Viejo, California, United States, 92691
      • Oceanside, California, United States, 92056
      • San Diego, California, United States, 92108
      • San Diego, California, United States, 92103-6204
      • Santa Clarita, California, United States, 91321
      • Upland, California, United States, 91786
      • Vista, California, United States, 92084
    • Colorado
      • Denver, Colorado, United States, 80202
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
      • Waterbury, Connecticut, United States, 06708
    • Delaware
      • Newark, Delaware, United States, 19713
    • Florida
      • Aventura, Florida, United States, 33180
      • Miami, Florida, United States, 33176
      • Pembroke Pines, Florida, United States, 33024
      • Tampa, Florida, United States, 33614
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Augusta, Georgia, United States, 30904
      • Decatur, Georgia, United States, 30033
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Indiana
      • Indianapolis, Indiana, United States, 46202
      • South Bend, Indiana, United States, 46601
    • Iowa
      • Des Moines, Iowa, United States, 50314
    • Kansas
      • Wichita, Kansas, United States, 67207
    • Maine
      • Bangor, Maine, United States, 04401
    • Maryland
      • Baltimore, Maryland, United States, 21209
    • Massachusetts
      • Worcester, Massachusetts, United States, 01610
    • Missouri
      • Florissant, Missouri, United States, 63031
      • St Louis, Missouri, United States, 63128
    • Nevada
      • Reno, Nevada, United States, 89502
    • New Jersey
      • Princeton, New Jersey, United States, 08540
      • Toms River, New Jersey, United States, 08753
    • New York
      • Orchard Park, New York, United States, 14127
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
    • Oregon
      • Eugene, Oregon, United States, 97401
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
      • Erie, Pennsylvania, United States, 16506
      • Erie, Pennsylvania, United States, 16502
      • Philadelphia, Pennsylvania, United States, 19148
      • Philadelphia, Pennsylvania, United States, 19114
      • Wyomissing, Pennsylvania, United States, 19610
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Dallas, Texas, United States, 75234
      • Houston, Texas, United States, 77024
    • Virginia
      • Newport News, Virginia, United States, 23602
      • Richmond, Virginia, United States, 23235
    • Washington
      • Seattle, Washington, United States, 98105
      • Seattle, Washington, United States, 98144
    • Wisconsin
      • Madison, Wisconsin, United States, 53705

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:

  • 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

Exclusion Criteria:

  • 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

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Ibandronate Then Alendronate
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.
Drug: Alendronate
Participants wil receive once-weekly oral alendronate (70 mg tablet)
Drug: Ibandronate
Participants wil receive once-monthly oral ibandronate (150 mg tablet)
Other Names:
  • Bonviva
Experimental: Group B: Alendronate Then Ibandronate
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.
Drug: Alendronate
Participants wil receive once-weekly oral alendronate (70 mg tablet)
Drug: Ibandronate
Participants wil receive once-monthly oral ibandronate (150 mg tablet)
Other Names:
  • Bonviva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate
Time Frame: Up to 6 months
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Up to 6 months
Incidence of adverse events
Time Frame: Up to approximately 1 year
Up to approximately 1 year

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

March 1, 2004

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 5, 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

  • MA17843

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.

Clinical Trials on Postmenopausal Osteoporosis

Clinical Trials on Alendronate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe