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

Osteoporosis Clinical Trial

Official title:

A Multicenter, Noninterventional, Prospective Study to Investigate the Efficacy and Safety After Administration of Daewoong Zoledronic Acid for the Purpose of Treatment or Prevention of Osteoporosis in Real-world Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614778
• Other study ID #: DWZA_OS01
• Status: Recruiting
• Start date: February 28, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2022
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Heejin Kim
• Phone: 010-9911-1728
• Email: hjkim221[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: April 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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 who are contraindicated in administration according to the approval of the research drug

2. Persons participating in other clinical trials

3. Those who have been judged by Investigator as unsuitable as subjects for this observational study

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Zoledronic Acid injection, 5mg/100mL
Zoledronic Acid injection, 5mg/100mL

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change in Bone Mineral Density (BMD)	The Rate of change in Bone Mineral Density (BMD) of the lumbar vertebrae	48 weeks from baseline