Clinical trial NCT02598440: A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis
Official title: A Randomized, Open-Label, Muti-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once-Monthly Ibandronate and Once-Weekly Alendronate. A Six Month, Two-Sequence, and Two-Period Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-05
Enrollment: 341
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 individuals.


Eligibility criteria: Inclusion Criteria:

* Ambulatory women
* Diagnosis of post-menopausal osteoporosis
* Women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry

Exclusion Criteria:

* Inability to stand or sit in the upright position for greater than or equal to 60 minutes
* Allergy to bisphosphonates;
* Previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry

Primary outcomes:
measure: Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate
timeFrame: Up to 6 months
Secondary outcomes:
measure: Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate.
timeFrame: Up to 6 months
measure: Incidence of adverse events
timeFrame: Up to approximately 1 year
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Laguna Woods
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Oceanside
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Clarita
country: United States
state: California
city: Upland
country: United States
state: California
city: Vista
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Cromwell
country: United States
state: Connecticut
city: Waterbury
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Aventura
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Bangor
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Worcester
country: United States
state: Massachusetts
city: Florissant
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Reno
country: United States
state: Nevada
city: Princeton
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Orchard Park
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Eugene
country: United States
state: Oregon
city: Duncansville
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Mount Pleasant
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Newport News
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: