OsteoporosisNCT05614778
Study to Investigate the Efficacy and Safety After Administration of Daewoong Zoledronic Acid for the Purpose of Treatment or Prevention of Osteoporosis
An observational study of Osteoporosis, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Zoledronic Acid injection, 5mg/100mL
- Type of treatment
- Injection or infusion
- How many people
- 2,881 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Feb 2022to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Study population was calculated by using PASS16, Confidence intervals for one mean procedure.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Zoledronic Acid injection, 5mg/100mL
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic Acid injection, 5mg/100mLOther
Zoledronic Acid injection, 5mg/100mL
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Zoledronic Acid inj. 5mg/100mL Receives: Other: Zoledronic Acid injection, 5mg/100mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar spine bone mineral density (BMD) change rate
Lumbar spine bone mineral density (BMD) change rate at 48 weeks compared to baseline
Measured: 48 weeks
Secondary outcomes (4)
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
Measured: 48 weeks
New clinical fracture incidence
New clinical fracture incidence at 48 weeks (%)
Measured: 48 weeks
Investigator satisfaction score
Investigator satisfaction score at 48 weeks
Measured: 48 weeks
Safety evaluation
Safety evaluation related to Daewoong zoledronic acid administration
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start28 Feb 2022
- Primary completion1 Feb 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,881 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yumie Lee, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614778
- Sponsor's protocol ID
- DWZA_OS01
- Status last verified
- Oct 2024
- First submitted
- 7 Nov 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05614778
- Acronym / sponsor ID
- DWZA_OS01
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,881 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Other: Zoledronic Acid injection, 5mg/100mLZoledronic Acid inj. 5mg/100mL |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Study population was calculated by using PASS16, Confidence intervals for one mean procedure.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Those subject to contraindications to administration according to the drug approval requirements for research
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic Acid injection, 5mg/100mLZoledronic Acid injection, 5mg/100mL | Other | Treatment group |
Primary outcome
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
4 secondary outcomes
Changes in lumbar spine, femur, hip joint, and bone mineral density (BMD)
Time frame: 48 weeks
New clinical fracture incidence
Time frame: 48 weeks
Investigator satisfaction score
Time frame: 48 weeks
Safety evaluation
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: Undecided. Not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yumie Lee principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar spine bone mineral density (BMD) change rate (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.