Post Menopausal Osteoporosis Clinical Trial
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
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Bosnia and Herzegovina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, Month 12 | No |
Primary | 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. | Baseline, Month 24 | No |
Primary | 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. | Baseline, Month 12 | No |
Primary | 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. | Baseline, Month 24 | No |
Secondary | 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. | Baseline, Month 12, Month 24 | No |
Secondary | 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. | Baseline, Month 12, Month 24 | No |
Secondary | Percentage of Participants Who Received All Planned Study Medication (Compliance) | Baseline up to Month 12 | No | |
Secondary | Correlation Coefficient of Participant's Profile With Compliance | Participant's profile included age, year since menopause, fracture history, and BMD at baseline. | Baseline up to Month 12 | No |
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