PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia

November 1, 2016 updated by: Hoffmann-La Roche

An Open-Label, Multi-Center Study to Determine Level of Adherence to Monthly Oral or Every Three Month Intravenous Ibandronate Treatment in Post-Menopausal Women With Osteoporosis or Osteopenia, Who Are GI Intolerant of Daily or Weekly Alendronate or Risendronate

The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

545

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
      • Montgomery, Alabama, United States, 36116
    • Arizona
      • Lake Havasu City, Arizona, United States, 86403
      • Paradise Valley, Arizona, United States, 85253
    • Arkansas
      • Pine Bluff, Arkansas, United States, 71603
    • California
      • San Diego, California, United States, 92103
      • San Diego, California, United States, 92108
      • Santa Monica, California, United States, 90404
      • Tacoma, California, United States, 98405
      • Vista, California, United States, 92083
    • Florida
      • Beverly Hills, Florida, United States, 34464
      • Fort Myers, Florida, United States, 33901
      • Gainesville, Florida, United States, 32605
      • Miami, Florida, United States, 33186
      • Ocala, Florida, United States, 34471
      • Palm Harbor, Florida, United States, 34684
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Augusta, Georgia, United States, 30904
    • Idaho
      • Coeur D'alene, Idaho, United States, 83814
    • Illinois
      • Champaign, Illinois, United States, 61820
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Louisiana
      • Natchitoches, Louisiana, United States, 71457
    • Maine
      • South Portland, Maine, United States, 04106
    • Michigan
      • Detroit, Michigan, United States, 48236
      • Detroit, Michigan, United States, 48202-2689
    • Minnesota
      • Chaska, Minnesota, United States, 55318
    • Missouri
      • Kansas City, Missouri, United States, 64114
      • St Louis, Missouri, United States, 63033
    • Montana
      • Billings, Montana, United States, 59101
    • Nebraska
      • Broken Bow, Nebraska, United States, 68822
      • Scottsbluff, Nebraska, United States, 69361
    • Nevada
      • Las Vegas, Nevada, United States, 89104
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • New York, New York, United States, 10003
      • West Haverstraw, New York, United States, 10993
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
      • Durham, North Carolina, United States, 27704
      • Salisbury, North Carolina, United States, 28144
      • Winston-salem, North Carolina, United States, 27103
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58104
    • Ohio
      • Canfield, Ohio, United States, 44406
      • Columbus, Ohio, United States, 43213
      • Mayfield, Ohio, United States, 44143
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
    • South Carolina
      • Loris, South Carolina, United States, 29569
      • Mount Pleasant, South Carolina, United States, 29464
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
      • Watertown, South Dakota, United States, 57201
    • Tennessee
      • Bristol, Tennessee, United States, 37620
    • Texas
      • Dallas, Texas, United States, 75231
      • Denton, Texas, United States, 76210
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78238
      • Seguin, Texas, United States, 78155
      • Temple, Texas, United States, 76508
    • Virginia
      • Norfolk, Virginia, United States, 23502
      • Richmond, Virginia, United States, 23298
      • Richmond, Virginia, United States, 23294
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with postmenopausal osteoporosis or osteopenia
  • Discontinuation of daily and /or weekly alendronate or risedronate therapy because of GI intolerance (eg, heartburn, acid reflux, stomach upset)

Exclusion Criteria:

  • Inability to stand or sit upright for 60 minutes
  • Inability to swallow a tablet whole - Hypersensitivity to any component of Boniva
  • Malignant disease diagnosed within previous 10 years (except resected basal cell cancer); contraindications for calcium or vitamin D therapy
  • Patients who do not fulfill a minimum 3 months wash-out therapy from any previous bisphosphonate therapy

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: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibandronate IV
Participants will receive ibandronate 3 mg IV once every 3 months
Drug: Ibandronate
Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months
Other Names:
  • Bonviva/Boniva
Experimental: Ibandronate Oral
Participants will receive ibandronate 150 milligrams (mg) tablet once monthly
Drug: Ibandronate
Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months
Other Names:
  • Bonviva/Boniva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants who have greater than or equal to (>=) 75 percent (%) adherence using either monthly oral ibandronate or quarterly intravenous (IV) ibandronate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants who have an adherence of >= 75% using ibandronate including both switch and non-switch participants
Time Frame: 12 months
12 months
Percentage of participants with GI events based on severity
Time Frame: Up to 10 months
Up to 10 months
Percentage of participants who experienced a change in frequency and number of GI events
Time Frame: Up to 10 months
Up to 10 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

January 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

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

  • ML18058

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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