Clinical trial NCT02598453: PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia
Official title: An Open-Label, Multi-Center Study to Determine Level of Adherence to Monthly Oral or Every Three Month Intravenous Ibandronate Treatment in Post-Menopausal Women With Osteoporosis or Osteopenia, Who Are GI Intolerant of Daily or Weekly Alendronate or Risendronate
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: 545
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 individuals.


Eligibility criteria: Inclusion Criteria:

* Women with postmenopausal osteoporosis or osteopenia
* Discontinuation of daily and /or weekly alendronate or risedronate therapy because of GI intolerance (eg, heartburn, acid reflux, stomach upset)

Exclusion Criteria:

* Inability to stand or sit upright for 60 minutes
* Inability to swallow a tablet whole - Hypersensitivity to any component of Boniva
* Malignant disease diagnosed within previous 10 years (except resected basal cell cancer); contraindications for calcium or vitamin D therapy
* Patients who do not fulfill a minimum 3 months wash-out therapy from any previous bisphosphonate therapy

Primary outcomes:
measure: Percentage of participants who have greater than or equal to (>=) 75 percent (%) adherence using either monthly oral ibandronate or quarterly intravenous (IV) ibandronate
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of participants who have an adherence of >= 75% using ibandronate including both switch and non-switch participants
timeFrame: 12 months
measure: Percentage of participants with GI events based on severity
timeFrame: Up to 10 months
measure: Percentage of participants who experienced a change in frequency and number of GI events
timeFrame: Up to 10 months
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Lake Havasu City
country: United States
state: Arizona
city: Paradise Valley
country: United States
state: Arizona
city: Pine Bluff
country: United States
state: Arkansas
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Tacoma
country: United States
state: California
city: Vista
country: United States
state: California
city: Beverly Hills
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Coeur D'alene
country: United States
state: Idaho
city: Champaign
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Natchitoches
country: United States
state: Louisiana
city: South Portland
country: United States
state: Maine
city: Detroit
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Chaska
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Broken Bow
country: United States
state: Nebraska
city: Scottsbluff
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: West Haverstraw
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Winston-salem
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Fargo
country: United States
state: North Dakota
city: Canfield
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Mayfield
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Wyomissing
country: United States
state: Pennsylvania
city: Loris
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Watertown
country: United States
state: South Dakota
city: Bristol
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Denton
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Seguin
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: