OsteoporosisNCT05966974
GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients
An observational study of Osteoporosis, run by AgNovos Healthcare, LLC at 1 site in Belgium.
Trial summary
The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated outside of any other clinical study… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporosis
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Dec 2022to 3 Apr 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Osteopenic and osteoporotic subjects receiving AGN1 LOEP treatment of the proximal femur.
Who may be able to join
- Subject has previously received AGN1 LOEP treatment between September 2019 and November 2022.
- Subject has willingness to participate in the study.
- Subject can give written informed consent to allow for data collection.
Who cannot join
- The subject's AGN1 LOEP treatment was previously performed as part of a prior protocoled clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Elective AGN1 LOEP in Osteopenic and Osteoporotic Subjects - a Retrospective Analysis
The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated outside of any other clinical study protocols between September 2019 and November 2022. A prospective questionnaire will be included to evaluate self-reported subject experiences.
- Conditions
- Osteoporosis
- Keywords
- Bone mineral density, Femoral strength, Hip fracture, Local osteo-enhancement procedure, LOEP, Proximal femur
- Medical subject headings
- Osteoporosis, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with AGN1 LOEP | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject satisfaction
Satisfaction level of subjects as measured by a Visual Analog Scale. The scale ranges from the lowest possible satisfaction to the highest possible satisfaction.
Measured: Through study completion, an average of 1.1 years
Subject Safety
Incidence of all adverse events and serious adverse events occurring intraoperative determined to be at least possibly related to the procedure and/or device.
Measured: During the procedure
Subject Safety
Incidence of all adverse events and serious adverse events occurring post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device.
Measured: Through study completion, an average of 1.1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start15 Dec 2022
- Primary completion3 Apr 2023
- Study completion3 Apr 2023
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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- AgNovos Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966974
- Sponsor's protocol ID
- AGN-CIP-302
- Status last verified
- Jul 2023
- First submitted
- 16 Dec 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Elective AGN1 LOEP in Osteopenic and Osteoporotic Subjects - a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT05966974
- Acronym / sponsor ID
- AGN-CIP-302
- Conditions
- Osteoporosis
- Keywords
- Bone mineral density, Femoral strength, Hip fracture, Local osteo-enhancement procedure, LOEP, Proximal femur
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AgNovos Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 1 Aug 2023 (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.
The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated outside of any other clinical study protocols between September 2019 and November 2022. A prospective questionnaire will be included to evaluate self-reported subject experiences.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with AGN1 LOEP | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Osteopenic and osteoporotic subjects receiving AGN1 LOEP treatment of the proximal femur.
Key inclusion criteria (3 listed)
- Subject has previously received AGN1 LOEP treatment between September 2019 and November 2022.
- Subject has willingness to participate in the study.
- Subject can give written informed consent to allow for data collection.
Key exclusion criteria (1 listed)
- The subject's AGN1 LOEP treatment was previously performed as part of a prior protocoled clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subject satisfaction
Time frame: Through study completion, an average of 1.1 years
Satisfaction level of subjects as measured by a Visual Analog Scale. The scale ranges from the lowest possible satisfaction to the highest possible satisfaction.
Subject Safety
Time frame: During the procedure
Incidence of all adverse events and serious adverse events occurring intraoperative determined to be at least possibly related to the procedure and/or device.
Subject Safety
Time frame: Through study completion, an average of 1.1 years
Incidence of all adverse events and serious adverse events occurring post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device.
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 1 Aug 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 AgNovos Healthcare, LLC at 1 site in Belgium.
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 1 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 1 Aug 2023. 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 Belgium. 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?
Subject satisfaction (time frame: Through study completion, an average of 1.1 years). The study lists 3 primary outcomes in all. 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 1 Aug 2023.