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Observational Study of iv Ibandronate in Women With Postmenopausal Osteoporosis

Information source: Clinic of Endocrinology and Metabolic Disorders, Macedonia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: Ibandronic acid (Drug)

Phase: N/A

Status: Completed

Sponsored by: Clinic of Endocrinology and Metabolic Disorders, Macedonia

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)

Clinical Details

Official title: Post Authorization Safety Study of iv Ibandronate (Bonviva) in Postmenopausal Osteoporosis, Observational, Non-interventional Open Label Trial

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: March 2009
Last updated: October 20, 2014

Page last updated: August 23, 2015

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