A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis

NCT ID: NCT02598934

Last Updated: 2016-03-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-05-31

Brief Summary

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This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.

Detailed Description

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Conditions

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Post Menopausal Osteoporosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ibandronate Group 1

Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 1 will receive a physician consultation after 4 months of treatment to review bone turnover test results.

Group Type EXPERIMENTAL

Ibandronate

Intervention Type DRUG

Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.

Ibandronate Group 2

Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation.

Group Type EXPERIMENTAL

Ibandronate

Intervention Type DRUG

Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.

Interventions

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Ibandronate

Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.

Intervention Type DRUG

Other Intervention Names

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Bonviva/Boniva

Eligibility Criteria

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Inclusion Criteria

* Women newly diagnosed with postmenopausal osteoporosis
* Naive to prior bisphosphonate therapy

Exclusion Criteria

* Inability to stand or sit upright for at least 60 minutes
* Inability to swallow a tablet whole
* Hypersensitivity to any component of ibandronate
* Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
* Other osteoporosis drug within last 3 months
* 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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Montgomery, Alabama, United States

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Chandler, Arizona, United States

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Peoria, Arizona, United States

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Hot Springs, Arkansas, United States

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Pine Bluff, Arkansas, United States

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Anaheim, California, United States

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Beverly Hills, California, United States

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Carmichael, California, United States

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Wilmington, Delaware, United States

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DeLand, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Palm Habor, Florida, United States

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Palm Springs, 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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Rome, Georgia, United States

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Morton Grove, Illinois, United States

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Indianapolis, Indiana, United States

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Waterloo, Iowa, United States

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Baltimore, Maryland, United States

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Hagerstown, Maryland, United States

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Reistertown, Maryland, United States

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Olive Branch, Mississippi, United States

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Jefferson City, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Bloomfield, New Jersey, United States

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New York, New York, United States

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The Bronx, New York, 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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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Doylestown, Pennsylvania, United States

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Langhorne, Pennsylvania, United States

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Philadelphia, Pennsylvania, 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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Morristown, Tennessee, United States

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Murfreesboro, Tennessee, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Fort Worth, Texas, United States

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San Antonio, Texas, United States

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Texarkana, Texas, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Madison, Wisconsin, United States

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Ponce, , Puerto Rico

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San Juan, , Puerto Rico

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San Juan, , Puerto Rico

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Countries

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United States Puerto Rico

Other Identifiers

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ML18057

Identifier Type: -

Identifier Source: org_study_id

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