Clinical trial NCT02604836: A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia
Official title: A Prospective, Open-Label, Multi-Center, Two-Part Study to Investigate Patient Satisfaction With Monthly Dosed Ibandronate Therapy in Women With Post-Menopausal Osteoporosis or Osteopenia Transitioned From Once-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: 2015-11-13
Enrollment: 1711
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate participant satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on study treatment is 6 months, and the target sample size is 1776 individuals.


Eligibility criteria: Inclusion Criteria:

- Women who had been receiving once-weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis for greater than or equal to (\>=) 3 months

Exclusion Criteria:

* Inability to stand or sit upright for \>=60 minutes
* Hypersensitivity to bisphosphonates
* Inability to swallow a tablet whole
* Malignant disease diagnosed within previous 10 years (except resected basal cell cancer).

Primary outcomes:
measure: Part A: Number of participants who currently use weekly biphosphonate who answer "yes" to any of the questions in Candidate Identification Questionnaire (CIQ)
timeFrame: Up to 30 days prior to baseline visit
measure: Part B: Number of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate
timeFrame: 6 months
measure: Part B: Percentage of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate
timeFrame: 6 months
Secondary outcomes:
measure: Part B: Percentage of eligible weekly biphosphonate users at screening who elect to enter Part B
timeFrame: Screening visit
measure: Part B: Percentage of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate
timeFrame: 6 months
measure: Part B: Percentage of participants who report preference to monthly ibandronate or weekly alendronate or risedronate
timeFrame: 6 months
measure: Part B: Percentage of participants who have greater than or equal to (>=) 80 percent (%) compliance
timeFrame: 6 months
measure: Part B: Percentage of participants who report an improvement in the gastrointestinal (GI) symptoms
timeFrame: 6 months
measure: Part B: Percentage of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)
timeFrame: 6 months
measure: Part B: Individual Domain scores from Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)
timeFrame: Baseline and 6 months
measure: Part B: Number of eligible weekly biphosphonate users at screening who elect to enter Part B
timeFrame: Screening Visit
measure: Part B: Number of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate
timeFrame: 6 months
measure: Part B: Number of participants who report preference to monthly ibandronate or weekly alendronate or risedronate
timeFrame: 6 months
measure: Part B: Number of participants who have >= 80% compliance
timeFrame: 6 months
measure: Part B: Number of participants who report an improvement in the GI symptoms
timeFrame: 6 months
measure: Part B: Number of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Columbiana
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Gilbert
country: United States
state: Arizona
city: Paradise Valley
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state: Arizona
city: Phoenix
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state: Arizona
city: Phoenix
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state: Arizona
city: Tempe
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state: Arizona
city: Tucson
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state: Arizona
city: Carlisle
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state: Arkansas
city: Jonesboro
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state: Arkansas
city: Little Rock
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state: Arkansas
city: Pine Bluff
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state: Arkansas
city: Rogers
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state: Arkansas
city: Searcy
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state: Arkansas
city: Sherwood
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Palm Desert
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state: California
city: Palo Alto
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state: California
city: Sacramento
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state: California
city: San Diego
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state: California
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state: California
city: Vista
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city: Westlake Village
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state: Colorado
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state: Connecticut
city: Cromwell
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city: Hamden
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city: New London
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city: Waterbury
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state: Connecticut
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state: Delaware
city: Aventura
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city: Clearwater
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city: Atlanta
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state: Georgia
city: Augusta
country: United States
state: Georgia
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city: Rome
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city: Coeur D'alene
country: United States
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city: Champaign
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city: Creve Coeur
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city: Omaha
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city: Middletown
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city: New Brunswick
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city: Princeton
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city: East Syracuse
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city: Stony Brook
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state: North Carolina
city: Durham
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city: Fayetteville
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city: Morehead City
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city: Morganton
country: United States
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city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
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city: Wilmington
country: United States
state: North Carolina
city: Winston-salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Grand Forks
country: United States
state: North Dakota
city: Beachwood
country: United States
state: Ohio
city: Canfield
country: United States
state: Ohio
city: Cincinnati
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city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
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city: Tulsa
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city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Bala Cynwyd
country: United States
state: Pennsylvania
city: Langhorne
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: Charleston
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Murfreesboro
country: United States
state: Tennessee
city: Nashville
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city: Sevierville
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state: Tennessee
city: Carrollton
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state: Texas
city: Corpus Christi
country: United States
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city: Dallas
country: United States
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city: Denton
country: United States
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city: San Antonio
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country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Renton
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: