NCT02271204CompletedNot Applicable
Post Authorization Safety Study of iv Ibandronate (Bonviva) in Postmenopausal Osteoporosis, Observational, Non-interventional Open Label Trial
Clinic of Endocrinology and Metabolic Disorders, Macedonia0 sites700 target enrollmentStarted: March 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 700
- Primary Endpoint
- Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability of intravenous Ibandronate intermittent administration in patients with postmenopausal osteoporosis
Study Overview
Brief Summary
This observational study assess the safety of intravenous Ibandronate (Bonviva) intermittent administration in patients with postmenopausal osteoporosis and the efficacy of IV Ibandronate (Bonviva treatment through relative lumbar spine and hip bone mineral densitometry form baseline at year 1)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients had post menopausal osteoporosis
- •Patients had no contraindication for bisphosphonates
- •Patients had been naive for ibandronate therapy
- •Patients who have signed informed consent and are willing to share their data for data analysis
Exclusion Criteria
- •Is not Ibandronate naïve
- •Hypersensitivity to any component of the bisphosphonates Ibandronate;
- •Administration of any investigational drug within 30 days preceding the first dose of the study drug.
Outcomes
Primary Outcomes
Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability of intravenous Ibandronate intermittent administration in patients with postmenopausal osteoporosis
Time Frame: end of observation 12 months
Secondary Outcomes
No secondary outcomes reported
Investigators
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