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Completed

NCT Number: NCT05614778

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei Severance Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Zoledronic Acid injection, 5mg/100mL

Other

Zoledronic Acid injection, 5mg/100mL

Primary outcomes

  1. Lumbar spine bone mineral density (BMD) change rate

    Time frame: 48 weeks

    Lumbar spine bone mineral density (BMD) change rate at 48 weeks compared to baseline

Secondary outcomes

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

    Time frame: 48 weeks

    Changes in lumbar spine, femur, hip joint, and bone mineral density (BMD) at 48 weeks compared to baseline

  2. New clinical fracture incidence

    Time frame: 48 weeks

    New clinical fracture incidence at 48 weeks (%)

  3. Investigator satisfaction score

    Time frame: 48 weeks

    Investigator satisfaction score at 48 weeks

  4. Safety evaluation

    Time frame: 48 weeks

    Safety evaluation related to Daewoong zoledronic acid administration

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2022
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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