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

Show 48 Study Locations

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 February 08, 2010