OsteoporosisNCT07594639
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
An observational study of Osteoporosis, run by AgNovos Healthcare, LLC at 1 site in Belgium.
Trial summary
The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. This will be a non-randomized and non-blinded study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoporosis
- What is being tested?
- AGN1 LOEP
- Type of treatment
- Medical device
- How many people
- 305 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All subjects whose AGN1 LOEP treatment was performed outside of a prior AgNovos sponsored clinical study are considered for this study. The study anticipates enrolling up to 305 subjects. The final sample size may be smaller depending on willingness to participate or subject availability
Who may be able to join
- Subject has previously received AGN1 LOEP treatment in the proximal femur after September 2019 and before January 2026.
- Subject can give written informed consent to allow for data collection. Obtaining informed consent is not required for deceased subjects.
Who cannot join
- -The subject's AGN1 LOEP treatment was previously performed as part of an AgNovos prior protocoled clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Retrospective Study of OSSURE LOEP in Osteopenic and Osteoporotic Subjects in the Commercial European Market
The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. 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 between September 2019 and January 2026. Subjects treated as part of an AgNovos prior protocoled study are excluded. Investigators are asked to reach out to all subjects that were previously treated with the AGN1 LOEP Kit in the proximal femur. Subject informed consent is obtained before a subject is enrolled into the study. Subjects treated but not enrolled are documented in a log with the reason why a subject did not participate. This log is kept on site. Enrolled subjects will be contacted per telephone to collect information about any fractures sustained post-AGN1 LOEP treatment.
- Conditions
- Osteoporosis
- Being tested
- AGN1 LOEP
- Keywords
- Bone mineral density, Femoral strength, Hip fracture, Local osteo-enhancement procedure, LOEP, Proximal femur, Osteogenesis Imperfecta, OI, Hypophosphatasia, HPP
- Medical subject headings
- Osteoporosis, Hip Fractures, Osteogenesis Imperfecta, Hypophosphatasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN1 LOEPDevice
Patients treated with AGN1 LOEP
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of fragility fractures of AGN1 LOEP treated hip
Measured: Through study completion, an average of 6 months.
Incidence of all adverse events and serious adverse events occurring intraoperative and post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
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
- 305 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AgNovos Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594639
- Sponsor's protocol ID
- AGN-CIP-304
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 19 May 2026
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of OSSURE LOEP in Osteopenic and Osteoporotic Subjects in the Commercial European Market
- ClinicalTrials.gov ID
- NCT07594639
- Acronym / sponsor ID
- AGN-CIP-304
- Conditions
- Osteoporosis
- Keywords
- Bone mineral density, Femoral strength, Hip fracture, Local osteo-enhancement procedure, LOEP, Proximal femur, Osteogenesis Imperfecta, OI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 305 participants (estimated)
- Lead sponsor
- AgNovos Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 May 2026 (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, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. 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 between September 2019 and January 2026. Subjects treated as part of an AgNovos prior protocoled study are excluded. Investigators are asked to reach out to all subjects that were previously treated with the AGN1 LOEP Kit in the proximal femur. Subject informed consent is obtained before a subject is enrolled into the study. Subjects treated but not enrolled are documented in a log with the reason why a subject did not participate. This log is kept on site. Enrolled subjects will be contacted per telephone to collect information about any fractures sustained post-AGN1 LOEP treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All subjects whose AGN1 LOEP treatment was performed outside of a prior AgNovos sponsored clinical study are considered for this study. The study anticipates enrolling up to 305 subjects. The final sample size may be smaller depending on willingness to participate or subject availability
Key inclusion criteria (2 listed)
- Subject has previously received AGN1 LOEP treatment in the proximal femur after September 2019 and before January 2026.
- Subject can give written informed consent to allow for data collection. Obtaining informed consent is not required for deceased subjects.
Key exclusion criteria (1 listed)
- -The subject's AGN1 LOEP treatment was previously performed as part of an AgNovos 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGN1 LOEPPatients treated with AGN1 LOEP | Device | – |
Primary outcome
Incidence of fragility fractures of AGN1 LOEP treated hip
Time frame: Through study completion, an average of 6 months.
Incidence of all adverse events and serious adverse events occurring intraoperative and post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device
Time frame: Through study completion, an average of 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- 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.
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 2 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: opening soon, as of the sponsor's last update on 19 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of fragility fractures of AGN1 LOEP treated hip (time frame: Through study completion, an average of 6 months.). The study lists 2 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 19 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.