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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.
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.
Age
55 - 80 years
Sex
FEMALE
Healthy Volunteers
No
Birmingham, Alabama, United States
Mesa, Arizona, United States
Scottsdale, Arizona, United States
Jonesboro, Arkansas, United States
Anaheim, California, United States
San Diego, California, United States
Waterbury, Connecticut, United States
Boynton Beach, Florida, United States
Jupiter, Florida, United States
Largo, Florida, United States
Start Date
May 1, 2006
Primary Completion Date
August 1, 2008
Completion Date
August 1, 2008
Last Updated
August 1, 2016
356
ACTUAL participants
Risedronate
DRUG
ibandronate [Bonviva/Boniva]
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT05571514
NCT02347865
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT00303485