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

NCT05614778 | Completed

• 1 other identifier: DWZA_OS01
• Study Type: observational
• Target: 2,881
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in lumbar spine, femur, hip joint, and bone mineral density (BMD)

  48 weeks

• New clinical fracture incidence

  48 weeks

• Investigator satisfaction score

  48 weeks

• Safety evaluation

  48 weeks

Study Arms (1)

Treatment group

Zoledronic Acid inj. 5mg/100mL

Other: Zoledronic Acid injection, 5mg/100mL

Interventions

Zoledronic Acid injection, 5mg/100mL OTHER

Zoledronic Acid injection, 5mg/100mL

Treatment group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Male and female adults 19 years of age or older at the time of screening visit
• A person who is scheduled to administer the research drug according to the medical judgment of the researcher based on the permission
• A person who can understand the information provided to the person and can voluntarily sign a written consent form

You may not qualify if:

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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yumie Lee

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: February 28, 2022
• Primary Completion: February 1, 2024
• Study Completion: May 31, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

KR (1)