Back to resultsBEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
Primary Purpose
Postmenopausal Osteoporosis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ibandronate [Bonviva/Boniva]
ibandronate [Bonviva/Boniva]
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- ambulatory post-menopausal women with osteoporosis;
- 55-85 years of age;
- eligible for bisphosphonate treatment;
- naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake > 6 months ago).
Exclusion Criteria:
- inability to stand or sit in an upright position for at least 60 minutes;
- inability to swallow a tablet whole;
- hypersensitivity to bisphosphonates;
- administration of any drug, or presence of active disease, known to influence bone metabolism;
- uncorrected hypocalcemia or other bone disturbances of bone and mineral metabolism;
- history of major upper gastrointestinal disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group
Secondary Outcome Measures
Patient satisfaction by OPSAT-Q and OPPS.
Tolerability; SAEs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00545909
Brief Title
BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
Official Title
A Randomised, Open Label Study to Investigate the Impact of Bone Marker Feedback at 2 Months on Adherence to Monthly Oral Bonviva (Ibandronate) in Women With Post-menopausal Osteoporosis.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (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 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ 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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
585 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ibandronate [Bonviva/Boniva]
Intervention Description
150mg po monthly for 6 months (+ feedback)
Intervention Type
Drug
Intervention Name(s)
ibandronate [Bonviva/Boniva]
Intervention Description
150mg po monthly for 6 months (- feedback)
Primary Outcome Measure Information:
Title
Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient satisfaction by OPSAT-Q and OPPS.
Time Frame
6 months
Title
Tolerability; SAEs.
Time Frame
Throughout study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ambulatory post-menopausal women with osteoporosis;
55-85 years of age;
eligible for bisphosphonate treatment;
naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake > 6 months ago).
Exclusion Criteria:
inability to stand or sit in an upright position for at least 60 minutes;
inability to swallow a tablet whole;
hypersensitivity to bisphosphonates;
administration of any drug, or presence of active disease, known to influence bone metabolism;
uncorrected hypocalcemia or other bone disturbances of bone and mineral metabolism;
history of major upper gastrointestinal disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Bregenz
ZIP/Postal Code
6900
Country
Austria
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Linz
ZIP/Postal Code
4020
Country
Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
Vöcklabruck
ZIP/Postal Code
4840
Country
Austria
City
Wien
ZIP/Postal Code
1021
Country
Austria
City
Wien
ZIP/Postal Code
1060
Country
Austria
City
Wien
ZIP/Postal Code
1100
Country
Austria
City
Wien
ZIP/Postal Code
1130
Country
Austria
City
Wien
ZIP/Postal Code
1150
Country
Austria
City
Wien
ZIP/Postal Code
1160
Country
Austria
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
City
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
City
AYE
ZIP/Postal Code
6900
Country
Belgium
City
Braine L'alleud
ZIP/Postal Code
1420
Country
Belgium
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1040
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1180
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
City
Dinant
ZIP/Postal Code
5500
Country
Belgium
City
Ekeren
ZIP/Postal Code
2180
Country
Belgium
City
Genk
ZIP/Postal Code
3600
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Godinne
ZIP/Postal Code
5530
Country
Belgium
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
City
Jambes
ZIP/Postal Code
5100
Country
Belgium
City
Knokke
ZIP/Postal Code
8300
Country
Belgium
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
City
La Louviere
ZIP/Postal Code
7100
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Liege
ZIP/Postal Code
4020
Country
Belgium
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
City
Mons
ZIP/Postal Code
7000
Country
Belgium
City
Oostende
ZIP/Postal Code
8400
Country
Belgium
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
City
Sijsele
ZIP/Postal Code
8340
Country
Belgium
City
Tournai
ZIP/Postal Code
7500
Country
Belgium
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
City
Waremme
ZIP/Postal Code
4300
Country
Belgium
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
City
Athens
ZIP/Postal Code
10682
Country
Greece
City
Athens
ZIP/Postal Code
16673
Country
Greece
City
Kifissia
ZIP/Postal Code
14561
Country
Greece
City
Larissa
ZIP/Postal Code
41110
Country
Greece
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
City
Thessaloniki
ZIP/Postal Code
55132
Country
Greece
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
City
Gorey
Country
Ireland
City
Tipperary
Country
Ireland
City
Luxembourg
ZIP/Postal Code
2311
Country
Luxembourg
City
Luxembourg
ZIP/Postal Code
2763
Country
Luxembourg
12. IPD Sharing Statement
Learn more about this trial
BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
We'll reach out to this number within 24 hrs