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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Other: Zoledronic Acid injection, 5mg/100mL

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.

• Study Type: Observational
• Enrollment (Actual): 2881

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The Study population was calculated by using PASS16, Confidence intervals for one mean procedure.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment group; Zoledronic Acid inj. 5mg/100mL	Other: Zoledronic Acid injection, 5mg/100mL; Zoledronic Acid injection, 5mg/100mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lumbar spine bone mineral density (BMD) change rate	Lumbar spine bone mineral density (BMD) change rate at 48 weeks compared to baseline	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in lumbar spine, femur, hip joint, and bone mineral density (BMD)	Changes in lumbar spine, femur, hip joint, and bone mineral density (BMD) at 48 weeks compared to baseline	48 weeks
New clinical fracture incidence	New clinical fracture incidence at 48 weeks (%)	48 weeks
Investigator satisfaction score	Investigator satisfaction score at 48 weeks	48 weeks
Safety evaluation	Safety evaluation related to Daewoong zoledronic acid administration	48 weeks

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Yumie Lee, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Bone Density Conservation Agents; Zoledronic Acid
• Other Study ID Numbers: DWZA_OS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No