Study to Investigate the Efficacy and Safety After Administration of Daewoong Zoledronic Acid for the Purpose of Treatment or Prevention of Osteoporosis

NCT ID: NCT05614778

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2881 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2024-05-31

Brief Summary

This study is a non-interventional observational study. On the baseline (Visit 1), we collect demographic data from all participating subjects according to their daily medical conditions, prescribe drugs and collect validity and safety data according to the research plan in Visit 1 and Visit 2. In addition, we collect data by application on subject's self-awareness symptoms and subject's questionnaire for medical outcome short form health survey (SF-36) every day from the baseline for 4 days.

Detailed Description

The investigator will enroll subjects according to Inclusion/Exclusion criteria after obtaining Informed Consent Form from each subject. Enrolled subjects will administer Zoledronic Acid 5mg/100mL once on baseline (Visit 1). The demographic data, prescription data, and medical history, etc will be collected based on the approved protocol. Additionally using application, subject's self-awareness symptoms and subject's questionnaire for medical outcome short form health survey (SF-36) every day from the baseline for 4 days will be collected.

Investigator will also collect any occurrence of fracture through electronic medical record until 48 weeks (Visit 2) from baseline visit.

Conditions

Osteoporosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment group

Zoledronic Acid inj. 5mg/100mL

Zoledronic Acid injection, 5mg/100mL

Intervention Type: OTHER

Zoledronic Acid injection, 5mg/100mL

Interventions

Zoledronic Acid injection, 5mg/100mL

Zoledronic Acid injection, 5mg/100mL

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male and female adults 19 years of age or older at the time of screening visit

2. A person who is scheduled to administer the research drug according to the medical judgment of the researcher based on the permission

3. A person who can understand the information provided to the person and can voluntarily sign a written consent form

Exclusion Criteria

1. Those subject to contraindications to administration according to the drug approval requirements for research

• Patients with hypersensitivity to the components of this drug or other bisphosphonate drugs Hypocalcemia
• Patients with severe renal impairment whose creatinine clearance rate is less than 35 mL/min (patients must measure serum creatinine and creatinine clearance before receiving the study drug).
• Patients receiving Zometa for cancer as an indication
• Pregnant women, women who may be pregnant, and lactating women

2. Patients participating in other clinical trials (However, registration is possible if you have not received investigational drugs or are participating in other non-interventional observational studies.)

3. In addition to the above, patients whom the researcher (physician in charge) determines are not suitable as subjects of this observational study.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yumie Lee

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Yonsei Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DWZA_OS01

Identifier Type: -

Identifier Source: org_study_id