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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
3 mg intravenously every 3 months
Unnamed facility
Banja Luka, Bosnia and Herzegovina
Unnamed facility
Sarajevo, Bosnia and Herzegovina
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.
Time frame: Baseline, Month 12
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.
Time frame: Baseline, Month 24
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.
Time frame: Baseline, Month 12
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.
Time frame: Baseline, Month 24
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.
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Time frame: Baseline, Month 12, Month 24
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.
Time frame: Baseline, Month 12, Month 24
Percentage of Participants Who Received All Planned Study Medication (Compliance)
Time frame: Baseline up to Month 12
Correlation Coefficient of Participant's Profile With Compliance
Participant's profile included age, year since menopause, fracture history, and BMD at baseline.
Time frame: Baseline up to Month 12