Observational Study of iv Ibandronate in Women With Postmenopausal Osteoporosis

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271204
• Other study ID #: ML21741
• Status: Completed
• Phase: N/A
• First received: October 7, 2014
• Last updated: October 20, 2014
• Start date: March 2009
• Est. completion date: April 2014

Study information

• Verified date: October 2014
• Source: Clinic of Endocrinology and Metabolic Disorders, Macedonia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Macedonia: Ministry of HealthMacedonia: Ethics Committee
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: April 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• Ibandronic acid
As prescribed by physician

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Clinic of Endocrinology and Metabolic Disorders, Macedonia	Clinic for Orthopedic Surgery, Skopje, General Hospital, Kumanovo, General Hospital, Struga, Medical Faculty, Institute for Epidemiology and Biostatistics, Skopje

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No