A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

NCT ID: NCT00377234

Last Updated: 2016-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-08-31

Brief Summary

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This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed Description

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Conditions

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Post Menopausal Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

ibandronate [Bonviva/Boniva]

Intervention Type DRUG

150mg po monthly for 3 months

2

Group Type ACTIVE_COMPARATOR

Risedronate

Intervention Type DRUG

35mg po weekly for 12 weeks

Interventions

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Risedronate

35mg po weekly for 12 weeks

Intervention Type DRUG

ibandronate [Bonviva/Boniva]

150mg po monthly for 3 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ambulatory women with post-menopausal osteoporosis;
* patients who are bisphosphonate-naive, or who have previously received oral daily or i.v. bisphosphonate therapy (fulfilling certain criteria detailed in the protocol).

Exclusion Criteria

* malignant disease diagnosed within previous 10 years (except for successfully resected basal cell cancer;) breast cancer within previous 20 years;
* inability to stand or sit upright for at least 60 minutes;
* disease/disorder/treatment with drugs known to influence bone metabolism.
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

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_DIRECTOR

Hoffmann-La Roche

Locations

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Birmingham, Alabama, United States

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Mesa, Arizona, United States

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Scottsdale, Arizona, United States

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Jonesboro, Arkansas, United States

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Anaheim, California, United States

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San Diego, California, United States

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Waterbury, Connecticut, United States

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Boynton Beach, Florida, United States

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Jupiter, Florida, United States

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Largo, Florida, United States

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Leesburg, Florida, United States

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Merritt Island, Florida, United States

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Ocala, Florida, United States

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Pembroke Pines, Florida, United States

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Spring Hill, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Douglasville, Georgia, United States

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Gainesville, Georgia, United States

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Marietta, Georgia, United States

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Madisonville, Kentucky, United States

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Bethesda, Maryland, United States

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Missoula, Montana, United States

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Omaha, Nebraska, United States

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Morehead City, North Carolina, United States

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New Bern, North Carolina, United States

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Jamestown, North Dakota, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Mogadore, Ohio, United States

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Tulsa, Oklahoma, United States

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Duncansville, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Feasterville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Anderson, South Carolina, United States

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Memphis, Tennessee, United States

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Selmer, Tennessee, United States

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Bedford, Texas, United States

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Bryan, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Temple, Texas, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Countries

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United States

Other Identifiers

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MA19547

Identifier Type: -

Identifier Source: org_study_id

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