Back to resultsA Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis
Primary Purpose
Post Menopausal Osteoporosis
Status
Completed
Phase
Phase 3
Locations
Bosnia and Herzegovina
Study Type
Interventional
Intervention
ibandronate [Bonviva/Boniva]
Sponsored by
About this trial
This is an interventional treatment trial for Post Menopausal Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Female patients, > 50 years of age
- Diagnosed osteoporosis
- Bone mineral density < minus 2.5 SD or osteoporotic fracture
- At least 3 years after menopause
Exclusion Criteria:
- Impaired renal function
- Contra-indication to Calcium or Vitamin D therapy
- Previous or current treatment with biphosphonates
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
Percent change was calculated as [(measure at time "t" minus [-] measure at baseline) divided by (/) measure at baseline] multiplied by (*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.
Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24
Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.
Percent Change From Baseline in Mean Hip Bone BMD at Month 12
Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.
Percent Change From Baseline in Mean Hip BMD at Month 24
Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.
Secondary Outcome Measures
Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24
Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.
Percent Change From Baseline in Total Hip T-score at Month 12 and 24
Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.
Percentage of Participants Who Received All Planned Study Medication (Compliance)
Correlation Coefficient of Participant's Profile With Compliance
Participant's profile included age, year since menopause, fracture history, and BMD at baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01290094
Brief Title
A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis
Official Title
Interventional, Single Arm, Open Label Study of the Efficacy, Safety and Compliance to the Treatment With Intravenous (IV) Ibandronate (Bonviva®) in the Postmenopausal Osteoporosis Treatment of Bisphosphonates naïve Patients in Daily Practice
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (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 single arm, open label study will assess the efficacy and safety of and compliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg intravenously every three months. Anticipated time on study treatment is 12 months with a follow-up of 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Menopausal Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ibandronate [Bonviva/Boniva]
Intervention Description
3 mg intravenously every 3 months
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
Description
Percent change was calculated as [(measure at time "t" minus [-] measure at baseline) divided by (/) measure at baseline] multiplied by (*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.
Time Frame
Baseline, Month 12
Title
Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24
Description
Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.
Time Frame
Baseline, Month 24
Title
Percent Change From Baseline in Mean Hip Bone BMD at Month 12
Description
Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.
Time Frame
Baseline, Month 12
Title
Percent Change From Baseline in Mean Hip BMD at Month 24
Description
Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.
Time Frame
Baseline, Month 24
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24
Description
Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.
Time Frame
Baseline, Month 12, Month 24
Title
Percent Change From Baseline in Total Hip T-score at Month 12 and 24
Description
Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.
Time Frame
Baseline, Month 12, Month 24
Title
Percentage of Participants Who Received All Planned Study Medication (Compliance)
Time Frame
Baseline up to Month 12
Title
Correlation Coefficient of Participant's Profile With Compliance
Description
Participant's profile included age, year since menopause, fracture history, and BMD at baseline.
Time Frame
Baseline up to Month 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients, > 50 years of age
Diagnosed osteoporosis
Bone mineral density < minus 2.5 SD or osteoporotic fracture
At least 3 years after menopause
Exclusion Criteria:
Impaired renal function
Contra-indication to Calcium or Vitamin D therapy
Previous or current treatment with biphosphonates
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
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
City
Sarajewo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
12. IPD Sharing Statement
Learn more about this trial
A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis
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