Clinical trial NCT00377234: A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Menopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-09-18
Enrollment: 356
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing
timeFrame: at 6 months
Secondary outcomes:
measure: Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate
timeFrame: within 6 months
measure: Intensity of Upper Gastrointestinal (GI) Symptoms
timeFrame: within 3 months
measure: Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)
timeFrame: 3 months
measure: Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)
timeFrame: 3 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: San Diego
country: United States
state: California
city: Waterbury
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Leesburg
country: United States
state: Florida
city: Merritt Island
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Spring Hill
country: United States
state: Florida
city: St Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Douglasville
country: United States
state: Georgia
city: Gainesville
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Madisonville
country: United States
state: Kentucky
city: Bethesda
country: United States
state: Maryland
city: Missoula
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Morehead City
country: United States
state: North Carolina
city: New Bern
country: United States
state: North Carolina
city: Jamestown
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Mogadore
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Duncansville
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Feasterville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Selmer
country: United States
state: Tennessee
city: Bedford
country: United States
state: Texas
city: Bryan
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: