NCT05614778Completed
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
Source: ClinicalTrials.gov · Last updated 18 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2881 (actual)
- First submitted
- 7 Nov 2022
- Start date
- 28 Feb 2022
- Primary completion date
- 1 Feb 2024
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Diseases
- Osteoporosis
- NCT number
- NCT05614778
What you commit to
- Study type: Observational
- Participants enrolled: 2881
- From 28 Feb 2022 to the primary completion date, 1 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.)
Lab values
- 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
Other
- In addition to the above, patients whom the researcher (physician in charge) determines are not suitable as subjects of this observational study.
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yonsei Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.