Clinical trial NCT05614778: Study to Investigate the Efficacy and Safety After Administration of Daewoong Zoledronic Acid for the Purpose of Treatment or Prevention of Osteoporosis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 2881
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Study population was calculated by using PASS16, Confidence intervals for one mean procedure.

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.

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.

Primary outcomes:
measure: Lumbar spine bone mineral density (BMD) change rate
timeFrame: 48 weeks
Secondary outcomes:
measure: Changes in lumbar spine, femur, hip joint, and bone mineral density (BMD)
timeFrame: 48 weeks
measure: New clinical fracture incidence
timeFrame: 48 weeks
measure: Investigator satisfaction score
timeFrame: 48 weeks
measure: Safety evaluation
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Yumie Lee
role: PRINCIPAL_INVESTIGATOR
References: