OsteoporosisNCT04511364
CONFIRM EXTENSION - Long-term Follow-up Study of Patients Treated with AGN1 LOEP
A study testing Clinical imaging is performed during the 24 and 60 month follow-up visits in people with Osteoporosis, run by AgNovos Healthcare, LLC at 1 site in Belgium.
Trial summary
The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Clinical imaging is performed during the 24 and 60 month follow-up visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Aug 2020to Dec 2025
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject had previously enrolled in CONFIRM and received AGN1 LOEP treatment.
- Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
- Subject is capable of giving written informed consent to participate in the study.
Who cannot join
- Subject was withdrawn from CONFIRM.
- Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Follow-up in Osteoporotic Women Treated with Local Osteo-Enhancement in Europe
The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP.
To qualify, subjects must have previously consented, enrolled, and been treated with the AGN1 LOEP kit in CONFIRM (AgNovos Study PST-EU-101.1).
Follow-up evaluations will be conducted at 24, 36, 48 and 60 months from the date the subject originally received the AGN1 LOEP treatment. Subjects will receive DXA and X-ray imaging at the 24- and 60-month follow-up visits. The 36- and 48-month follow-up evaluations will be conducted by phone. All timepoints will include general health and medical record review.
- Conditions
- Osteoporosis
- Being tested
- Clinical imaging is performed during the 24 and 60 month follow-up visits
- Keywords
- local osteo-enhancement procedure, hip fracture/prevention and control, calcium phosphate, calcium sulphate, LOEP, CONFIRM Extension
- 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.
Clinical imaging is performed during the 24 and 60 month follow-up visitsOther
X-ray and DXA scan
| Study group | Role | What they receive |
|---|---|---|
| AGN1 treated patients | Experimental | Patients have been treated with the AGN1 LOEP kit in AgNovos study PST-EU-101.1. An X-ray and DXA scan are performed at 24 and 60 months post AGN1 LOEP treatment. Receives: Other: Clinical imaging is performed during the 24 and 60 month follow-up visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DXA score at 24 months
Change in DXA score of treated hip from baseline pre-AGN1 LOEP to 24 months post-treatment.
Measured: 24 months
Secondary outcomes (3)
Change in DXA score at 60 months
Change in DXA score of treated hip from pre-AGN1 LOEP to 60 months post-treatment.
Measured: 60 months
Hip fracture incidence
The incidence of hip fracture on the treated side during the follow-up period through 60 months post-AGN1 LOEP treatment.
Measured: 60 months
Radiologic bone formation
Radiologic appearance of bone formation as assessed by X-ray at 24 and 60 months post-treatment.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start28 Aug 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AgNovos Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jo De Schepper, MD, Principal investigator, AZ Nikolaas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511364
- Sponsor's protocol ID
- AGN-CIP-300
- Status last verified
- Jan 2025
- First submitted
- 4 Aug 2020
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Howe JG, Hill RS, Stroncek JD, Shaul JL, Favell D, Cheng RR, Engelke K, Genant HK, Lee DC, Keaveny TM, Bouxsein ML, Huber B. Treatment of bone loss in proximal femurs of postmenopausal osteoporotic women with AGN1 local osteo-enhancement procedure (LOEP) increases hip bone mineral density and hip strength: a long-term prospective cohort study. Osteoporos Int. 2020 May;31(5):921-929. doi: 10.1007/s00198-019-05230-0. Epub 2019 Dec 4.
PubMed 31802158Stroncek JD, Shaul JL, Favell D, Hill RS, Huber BM, Howe JG, Bouxsein ML. In vitro injection of osteoporotic cadaveric femurs with a triphasic calcium-based implant confers immediate biomechanical integrity. J Orthop Res. 2019 Apr;37(4):908-915. doi: 10.1002/jor.24239. Epub 2019 Mar 20.
PubMed 30793358
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up in Osteoporotic Women Treated with Local Osteo-Enhancement in Europe
- ClinicalTrials.gov ID
- NCT04511364
- Acronym / sponsor ID
- AGN-CIP-300
- Conditions
- Osteoporosis
- Keywords
- local osteo-enhancement procedure, hip fracture/prevention and control, calcium phosphate, calcium sulphate, LOEP, CONFIRM Extension
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AgNovos Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Aug 2020 (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 multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP.
To qualify, subjects must have previously consented, enrolled, and been treated with the AGN1 LOEP kit in CONFIRM (AgNovos Study PST-EU-101.1).
Follow-up evaluations will be conducted at 24, 36, 48 and 60 months from the date the subject originally received the AGN1 LOEP treatment. Subjects will receive DXA and X-ray imaging at the 24- and 60-month follow-up visits. The 36- and 48-month follow-up evaluations will be conducted by phone. All timepoints will include general health and medical record review.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AGN1 treated patients | Experimental | Other: Clinical imaging is performed during the 24 and 60 month follow-up visitsPatients have been treated with the AGN1 LOEP kit in AgNovos study PST-EU-101.1. An X-ray and DXA scan are performed at 24 and 60 months post AGN1 LOEP treatment. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subject had previously enrolled in CONFIRM and received AGN1 LOEP treatment.
- Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
- Subject is capable of giving written informed consent to participate in the study.
Key exclusion criteria (2 listed)
- Subject was withdrawn from CONFIRM.
- Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate.
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 |
|---|---|---|
| Clinical imaging is performed during the 24 and 60 month follow-up visitsX-ray and DXA scan | Other | AGN1 treated patients |
Primary outcome
Change in DXA score at 24 months
Time frame: 24 months
Change in DXA score of treated hip from baseline pre-AGN1 LOEP to 24 months post-treatment.
3 secondary outcomes
Change in DXA score at 60 months
Time frame: 60 months
Hip fracture incidence
Time frame: 60 months
Radiologic bone formation
Time frame: 60 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 31 Jan 2025.
- Background: PubMed 31802158Howe JG, Hill RS, Stroncek JD, Shaul JL, Favell D, Cheng RR, Engelke K, Genant HK, Lee DC, Keaveny TM, Bouxsein ML, Huber B. Treatment of bone loss in proximal femurs of postmenopausal osteoporotic women with AGN1 local osteo-enhancement procedure (LOEP) increases hip bone mineral density and hip strength: a long-term prospective cohort study. Osteoporos Int. 2020 May;31(5):921-929. doi: 10.1007/s00198-019-05230-0. Epub 2019 Dec 4.
- Background: PubMed 30793358Stroncek JD, Shaul JL, Favell D, Hill RS, Huber BM, Howe JG, Bouxsein ML. In vitro injection of osteoporotic cadaveric femurs with a triphasic calcium-based implant confers immediate biomechanical integrity. J Orthop Res. 2019 Apr;37(4):908-915. doi: 10.1002/jor.24239. Epub 2019 Mar 20.
- 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.
Jo De Schepper, MD principal investigator
AZ Nikolaas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical imaging is performed during the 24 and 60 month follow-up visits in people with 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 2 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: under way, not looking for participants, as of the sponsor's last update on 31 Jan 2025. 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?
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?
Change in DXA score at 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04511364, which also lists 2 linked publications.
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 31 Jan 2025.