Osteoporosis
Conditions
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)
Interventions
DRUGIbandronic acid
As prescribed by physician
Sponsors
Clinic for Orthopedic Surgery, Skopje
General Hospital, Kumanovo
General Hospital, Struga
Medical Faculty, Institute for Epidemiology and Biostatistics, Skopje
Clinic of Endocrinology and Metabolic Disorders, Macedonia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | end of observation 12 months |
Outcome results
None listed