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A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ibandronate
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ibandronate

Arm Description

Participants will receive 150 milligrams (mg) of ibandronate as a film-coated tablet once-monthly.

Outcomes

Primary Outcome Measures

Part A: Number of participants who currently use weekly biphosphonate who answer "yes" to any of the questions in Candidate Identification Questionnaire (CIQ)
Part B: Number of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate
Part B: Percentage of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate

Secondary Outcome Measures

Part B: Percentage of eligible weekly biphosphonate users at screening who elect to enter Part B
Part B: Percentage of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate
Part B: Percentage of participants who report preference to monthly ibandronate or weekly alendronate or risedronate
Part B: Percentage of participants who have greater than or equal to (>=) 80 percent (%) compliance
Part B: Percentage of participants who report an improvement in the gastrointestinal (GI) symptoms
Part B: Percentage of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)
Part B: Individual Domain scores from Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)
Part B: Number of eligible weekly biphosphonate users at screening who elect to enter Part B
Part B: Number of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate
Part B: Number of participants who report preference to monthly ibandronate or weekly alendronate or risedronate
Part B: Number of participants who have >= 80% compliance
Part B: Number of participants who report an improvement in the GI symptoms
Part B: Number of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)

Full Information

First Posted
November 6, 2015
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02604836
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1711 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibandronate
Arm Type
Experimental
Arm Description
Participants will receive 150 milligrams (mg) of ibandronate as a film-coated tablet once-monthly.
Intervention Type
Drug
Intervention Name(s)
Ibandronate
Other Intervention Name(s)
Bonviva/Boniva
Intervention Description
Film-coated oral ibandronate tablet (150 mg) once-monthly
Primary Outcome Measure Information:
Title
Part A: Number of participants who currently use weekly biphosphonate who answer "yes" to any of the questions in Candidate Identification Questionnaire (CIQ)
Time Frame
Up to 30 days prior to baseline visit
Title
Part B: Number of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate
Time Frame
6 months
Title
Part B: Percentage of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Part B: Percentage of eligible weekly biphosphonate users at screening who elect to enter Part B
Time Frame
Screening visit
Title
Part B: Percentage of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate
Time Frame
6 months
Title
Part B: Percentage of participants who report preference to monthly ibandronate or weekly alendronate or risedronate
Time Frame
6 months
Title
Part B: Percentage of participants who have greater than or equal to (>=) 80 percent (%) compliance
Time Frame
6 months
Title
Part B: Percentage of participants who report an improvement in the gastrointestinal (GI) symptoms
Time Frame
6 months
Title
Part B: Percentage of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)
Time Frame
6 months
Title
Part B: Individual Domain scores from Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)
Time Frame
Baseline and 6 months
Title
Part B: Number of eligible weekly biphosphonate users at screening who elect to enter Part B
Time Frame
Screening Visit
Title
Part B: Number of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate
Time Frame
6 months
Title
Part B: Number of participants who report preference to monthly ibandronate or weekly alendronate or risedronate
Time Frame
6 months
Title
Part B: Number of participants who have >= 80% compliance
Time Frame
6 months
Title
Part B: Number of participants who report an improvement in the GI symptoms
Time Frame
6 months
Title
Part B: Number of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q)
Time Frame
6 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
City
Columbiana
State/Province
Alabama
ZIP/Postal Code
35051
Country
United States
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85295
Country
United States
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
Carlisle
State/Province
Arkansas
ZIP/Postal Code
72024
Country
United States
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72756
Country
United States
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143
Country
United States
City
Sherwood
State/Province
Arkansas
ZIP/Postal Code
72120
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
City
Tacoma
State/Province
California
ZIP/Postal Code
98405
Country
United States
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
City
Avon
State/Province
Connecticut
ZIP/Postal Code
06001
Country
United States
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19805
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Palm Bay
State/Province
Florida
ZIP/Postal Code
32905
Country
United States
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
City
Coeur D'alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
City
Creve Coeur
State/Province
Illinois
ZIP/Postal Code
61610
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
City
Arkansas City
State/Province
Kansas
ZIP/Postal Code
67005
Country
United States
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
City
Natchitoches
State/Province
Louisiana
ZIP/Postal Code
71457
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
St Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07012
Country
United States
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
City
Olean
State/Province
New York
ZIP/Postal Code
14760
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8161
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Winston-salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Canfield
State/Province
Ohio
ZIP/Postal Code
44406
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Sevierville
State/Province
Tennessee
ZIP/Postal Code
37862
Country
United States
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1912
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia

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