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

NCT ID: NCT02598440

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

341 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postmenopausal Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Alendronate

Intervention Type DRUG

Participants wil receive once-weekly oral alendronate (70 mg tablet)

Ibandronate

Intervention Type DRUG

Participants wil receive once-monthly oral ibandronate (150 mg tablet)

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.

Group Type EXPERIMENTAL

Alendronate

Intervention Type DRUG

Participants wil receive once-weekly oral alendronate (70 mg tablet)

Ibandronate

Intervention Type DRUG

Participants wil receive once-monthly oral ibandronate (150 mg tablet)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alendronate

Participants wil receive once-weekly oral alendronate (70 mg tablet)

Intervention Type DRUG

Ibandronate

Participants wil receive once-monthly oral ibandronate (150 mg tablet)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bonviva

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Huntsville, Alabama, United States

Site Status

Phoenix, Arizona, United States

Site Status

Tempe, Arizona, United States

Site Status

Laguna Woods, California, United States

Site Status

Mission Viejo, California, United States

Site Status

Oceanside, California, United States

Site Status

San Diego, California, United States

Site Status

San Diego, California, United States

Site Status

Santa Clarita, California, United States

Site Status

Upland, California, United States

Site Status

Vista, California, United States

Site Status

Denver, Colorado, United States

Site Status

Cromwell, Connecticut, United States

Site Status

Waterbury, Connecticut, United States

Site Status

Newark, Delaware, United States

Site Status

Aventura, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Pembroke Pines, Florida, United States

Site Status

Tampa, Florida, United States

Site Status

West Palm Beach, Florida, United States

Site Status

Augusta, Georgia, United States

Site Status

Decatur, Georgia, United States

Site Status

Chicago, Illinois, United States

Site Status

Indianapolis, Indiana, United States

Site Status

South Bend, Indiana, United States

Site Status

Des Moines, Iowa, United States

Site Status

Wichita, Kansas, United States

Site Status

Bangor, Maine, United States

Site Status

Baltimore, Maryland, United States

Site Status

Worcester, Massachusetts, United States

Site Status

Florissant, Missouri, United States

Site Status

St Louis, Missouri, United States

Site Status

Reno, Nevada, United States

Site Status

Princeton, New Jersey, United States

Site Status

Toms River, New Jersey, United States

Site Status

Orchard Park, New York, United States

Site Status

Raleigh, North Carolina, United States

Site Status

Eugene, Oregon, United States

Site Status

Duncansville, Pennsylvania, United States

Site Status

Erie, Pennsylvania, United States

Site Status

Erie, Pennsylvania, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Wyomissing, Pennsylvania, United States

Site Status

Warwick, Rhode Island, United States

Site Status

Mt. Pleasant, South Carolina, United States

Site Status

Nashville, Tennessee, United States

Site Status

Dallas, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Newport News, Virginia, United States

Site Status

Richmond, Virginia, United States

Site Status

Seattle, Washington, United States

Site Status

Seattle, Washington, United States

Site Status

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MA17843

Identifier Type: -

Identifier Source: org_study_id