NCT02271204

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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
Last Updated

October 22, 2014

Status Verified

October 1, 2014

Enrollment Period

4.1 years

First QC Date

October 7, 2014

Last Update Submit

October 20, 2014

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Ibandronic acidDRUG

As prescribed by physician

Also known as: Bonviva

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoporosis

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 22, 2014

Study Start

March 1, 2009

Primary Completion

April 1, 2013

Study Completion

April 1, 2014

Last Updated

October 22, 2014

Record last verified: 2014-10