Observational Study of iv Ibandronate in Women With Postmenopausal Osteoporosis

October 20, 2014 updated by: Clinic of Endocrinology and Metabolic Disorders, Macedonia

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women with postmenopausal osteoporosis in everyday routine practice from selected centers in R. Macedonia

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: end of observation 12 months
end of observation 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinic of Endocrinology and Metabolic Disorders, Macedonia

Collaborators

Clinic for Orthopedic Surgery, Skopje
General Hospital, Kumanovo
General Hospital, Struga
Medical Faculty, Institute for Epidemiology and Biostatistics, Skopje

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

October 7, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Estimate)

October 22, 2014

Last Update Submitted That Met QC Criteria

October 20, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21741

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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