BONVIVA(Ibandronate) Injection PMS(Post-marketing Surveillance)

NCT01376102 | Completed

• 1 other identifier: 111412
• Study Type: observational
• Target: 657
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, multi-centre, non-interventional post-marketing surveillance

Conditions

Osteoporosis

Keywords

osteoporosis; ibandronate

Outcome Measures

Primary Outcomes (1)

• The number of adverse event after ibandronate administration

  6 months

Secondary Outcomes (3)

• The number of unexpected adverse drug reaction after BONVIVA(ibandronate) injection administration

  6 months

• The number of serious adverse event after BONVIVA(ibandronate) injection administration

  6 months

• Effectiveness of BONVIVA(ibandronate) injection treatment

  6 months

Study Arms (1)

BONVIVA(ibandronate)

Patients administrated ibandronate injection with postmenopausal osteoporosis

Drug: BONVIVA(ibandronate) injection

Interventions

BONVIVA(ibandronate) injection DRUG

Basically there is no treatment allocation. Subjects who would be administered of ibandronate at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

BONVIVA(ibandronate)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients administrated BONVIVA(ibandronate) injection with postmenopausal osteoporosis

You may qualify if:

• All subjects must satisfy the following criteria at study entry:
• Subjects administered with BONVIVA(ibandronate) injection following the locally approved prescribing information Women diagnosed with postmenopausal osteoporosis. Subjects who the investigator believes that they can and will comply with the requirements of the protocol Subjects with no experience of treatment using ibandronate injection Note: Subjects, who have experience of other bisphosphonates treatment, can be included.
• Subjects who are indicated and administered of ibandronate injection according to the Prescribing Information in normal prescription use

You may not qualify if:

• The following criteria should be checked at the time of study entry.
• According to contraindication on the prescribing information, ibandronate injection should not be administered to the following patients:
• Patients with known hypersensitivity to ibandronate injection or to any of its excipients Uncorrected hypocalcemia Note: Ibandronate injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Injections

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 20, 2011
• Study Start: November 1, 2007
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 16, 2014

Record last verified: 2014-06

Locations

KR (1)