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

Condition(s) targeted: Post-Menopausal Osteoporosis

Intervention: ibandronate [Bonviva/Boniva] (Drug); Risedronate (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

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.

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.

Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Proportion of patients preferring monthly dosing with Bonviva over weekly dosing with risedronate

Secondary outcome:

Convenience of monthly Bonviva over weekly risedronate

Change in serum CTX

Upper gastrointestinal symptoms

AEs and laboratory parameters

Minimum age: 55 Years. Maximum age: 80 Years. Gender(s): Female.

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.

BIRMINGHAM, Alabama 35294-3708, United States

SCOTTSDALE, Arizona 85251, United States

MESA, Arizona 85213, United States

JONESBORO, Arkansas 72401, United States

ANAHEIM, California 92801, United States

SAN DIEGO, California 92108, United States

WATERBURY, Connecticut 06708, United States

WEST PALM BEACH, Florida 33409, United States

BOYNTON BEACH, Florida 33437, United States

SPRING HILL, Florida 34667, United States

ST PETERSBURG, Florida 33709, United States

PEMBROKE PINES, Florida 33024, United States

LARGO, Florida 33777, United States

TAMPA, Florida 33614, United States

LEESBURG, Florida 34748, United States

MERRITT ISLAND, Florida 32952, United States

OCALA, Florida 34471, United States

JUPITER, Florida 33458, United States

DOUGLASVILLE, Georgia 30134, United States

MARIETTA, Georgia 30060, United States

GAINESVILLE, Georgia 30501, United States

MADISONVILLE, Kentucky 42431, United States

BETHESDA, Maryland 20817, United States

MISSOULA, Montana 59801, United States

OMAHA, Nebraska 68134, United States

MOREHEAD CITY, North Carolina 28557, United States

NEW BERN, North Carolina 28562, United States

JAMESTOWN, North Dakota 58401, United States

MOGADORE, Ohio 44260, United States

CINCINNATI, Ohio 45236, United States

CINCINNATI, Ohio 45224, United States

TULSA, Oklahoma 74104, United States

DUNCANSVILLE, Pennsylvania 16635, United States

PHILADELPHIA, Pennsylvania 19114, United States

ERIE, Pennsylvania 16506, United States

FEASTERVILLE, Pennsylvania 19053, United States

ANDERSON, South Carolina 29621, United States

MEMPHIS, Tennessee 38120, United States

SELMER, Tennessee 38375, United States

HOUSTON, Texas 77024, United States

BEDFORD, Texas 76021, United States

TEMPLE, Texas 76502, United States

HOUSTON, Texas 77030, United States

BRYAN, Texas 77802, United States

RICHMOND, Virginia 23235, United States

RICHMOND, Virginia 23294, United States

SEATTLE, Washington 98105, United States

MADISON, Wisconsin 53705, United States

Starting date: May 2006
Ending date: July 2007
Last updated: June 17, 2008