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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00377234

Purpose

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.

Condition	Intervention	Phase
Post-Menopausal Osteoporosis	Drug: ibandronate [Bonviva/Boniva] Drug: Risedronate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Official Title:	Randomized, Open-Label, Multi-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once Monthly Ibandronate and Once Weekly Risedronate. A Six Month, Two-Sequence and Two-Period Crossover Study.

Resource links provided by NLM:

MedlinePlus related topics: Menopause Osteoporosis

Drug Information available for: Risedronic acid Ibandronic acid Risedronate sodium Ibandronate sodium

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Proportion of patients preferring monthly dosing with Bonviva over weekly dosing with risedronate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Convenience of monthly Bonviva over weekly risedronate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in serum CTX [ Time Frame: 12 weeks/3 months ] [ Designated as safety issue: No ]
Upper gastrointestinal symptoms [ Time Frame: 12 weeks/3 months ] [ Designated as safety issue: No ]
AEs and laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	356
Study Completion Date:	August 2008

Arms	Assigned Interventions
1: Experimental	Drug: ibandronate [Bonviva/Boniva] 150mg po monthly for 3 months
2: Active Comparator	Drug: Risedronate 35mg po weekly for 12 weeks

Eligibility

Ages Eligible for Study:	55 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377234

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Locations

United States, Alabama

BIRMINGHAM, Alabama, United States, 35294-3708
United States, Arizona

SCOTTSDALE, Arizona, United States, 85251

MESA, Arizona, United States, 85213
United States, Arkansas

JONESBORO, Arkansas, United States, 72401
United States, California

ANAHEIM, California, United States, 92801

SAN DIEGO, California, United States, 92108
United States, Connecticut

WATERBURY, Connecticut, United States, 06708
United States, Florida

WEST PALM BEACH, Florida, United States, 33409

BOYNTON BEACH, Florida, United States, 33437

SPRING HILL, Florida, United States, 34667

ST PETERSBURG, Florida, United States, 33606

PEMBROKE PINES, Florida, United States, 33024

LARGO, Florida, United States, 33777

TAMPA, Florida, United States, 33614

LEESBURG, Florida, United States, 34748

MERRITT ISLAND, Florida, United States, 32952

OCALA, Florida, United States, 34471

JUPITER, Florida, United States, 33458
United States, Georgia

DOUGLASVILLE, Georgia, United States, 30134

MARIETTA, Georgia, United States, 30060

GAINESVILLE, Georgia, United States, 30501
United States, Kentucky

MADISONVILLE, Kentucky, United States, 42431
United States, Maryland

BETHESDA, Maryland, United States, 20817
United States, Montana

MISSOULA, Montana, United States, 59801
United States, Nebraska

OMAHA, Nebraska, United States, 68134
United States, North Carolina

MOREHEAD CITY, North Carolina, United States, 28557

NEW BERN, North Carolina, United States, 28562
United States, North Dakota

JAMESTOWN, North Dakota, United States, 58401
United States, Ohio

MOGADORE, Ohio, United States, 44260

CINCINNATI, Ohio, United States, 45236

CINCINNATI, Ohio, United States, 45224
United States, Oklahoma

TULSA, Oklahoma, United States, 74104
United States, Pennsylvania

DUNCANSVILLE, Pennsylvania, United States, 16635

PHILADELPHIA, Pennsylvania, United States, 19114

ERIE, Pennsylvania, United States, 16506

FEASTERVILLE, Pennsylvania, United States, 19053
United States, South Carolina

ANDERSON, South Carolina, United States, 29621
United States, Tennessee

MEMPHIS, Tennessee, United States, 38120

SELMER, Tennessee, United States, 38375
United States, Texas

HOUSTON, Texas, United States, 77024

BEDFORD, Texas, United States, 76021

TEMPLE, Texas, United States, 76502

HOUSTON, Texas, United States, 77030

DALLAS, Texas, United States, 75231

BRYAN, Texas, United States, 77802
United States, Virginia

RICHMOND, Virginia, United States, 23235

RICHMOND, Virginia, United States, 23294
United States, Washington

SEATTLE, Washington, United States, 98105

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	MA19547
Study First Received:	September 15, 2006
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00377234 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Osteoporosis
Calcium Channel Blockers
Bone Diseases, Metabolic
Bone Density Conservation Agents
Cardiovascular Agents
Bone Diseases

Pharmacologic Actions
Membrane Transport Modulators
Musculoskeletal Diseases
Ibandronic acid
Therapeutic Uses
Osteoporosis, Postmenopausal
Risedronic acid

ClinicalTrials.gov processed this record on November 25, 2009