OsteoporosisNCT05202678
RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis
A study testing AGN1 LOEP in people with Osteoporosis, run by AgNovos Healthcare, LLC at 1 site in Belgium.
Trial summary
The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- AGN1 LOEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Jul 2021to Dec 2026
- 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 is a postmenopausal female (at least 1-year post menses).
- Subject has bone loss in the hip attributable to osteoporosis as defined by a femoral neck DXA T-score of -2.5 or less.
- Subject has at least one hip without previous surgery or fracture.
- Subject is medically stable from any previous treatment or medical procedure in the opinion of the investigator and with an ASA score of I or II.
- 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 is less than 3 months removed from having a hip fracture repair or prosthesis or elective Total Hip Arthroplasty (THA).
- Subject has progressive increase in hip pain over the previous six (6) months that in the opinion of the Investigator suggests moderate to severe intra-articular arthritis, labral tear, extraarticular soft tissue pathology, referred pain, tumor, stress fracture or infection.
- Subject is dependent on the use of a wheelchair or is bedridden.
- Subject has albumin corrected serum calcium levels outside the normal lab range or has a pre-existing calcium metabolism disorder (e.g., hypercalcemia).
- Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min or is being treated with dialysis.
- Subject has hemoglobin A1c level ≥ 7.5%.
Show all 20Show fewer
- Subject has Body Mass Index (BMI) > 35.
- Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator*.
- Subject is at ASA Class III, IV, V or VI.
- Subject exhibits excessive alcohol consumption as determined by the principal investigator*.
- Subject has radiological evidence of gross bony or joint pathology of the hip, including signs predictive of atypical femoral fractures (e.g., Cortical beaking) or has been diagnosed and/or treated for atypical femoral fractures.
- Subject treated with corticosteroids or systemic glucocorticoids for ten (10) days in the previous six (6) months.
- Subject has history of oral or parenteral use of immunesuppressive drugs in the previous twelve months.
- Subject has history of metabolic bone disease other than osteoporosis (ex. Paget's disease).
- Subject has a history of auto-immune arthritic diseases including rheumatoid, psoriatic, or those associated with systemic lupus erythematosus, spondyloarthropathy, Reiter's Syndrome or Crohn's Disease.
- Subject has a history of radiation therapy to the hip or pelvic region.
- Subject has a history of any invasive malignancy (except basal cell carcinoma), unless treated and with no clinical signs or symptoms of the malignancy for five (5) years.
- Subject has known allergies to implanted device.
- In the judgement of the Investigator, the subject is not a good study candidate (e.g., inability to maintain follow-up schedule, comorbidity or poor general physical/mental health, or drug or alcohol abuse issues).
- Subject is currently enrolled in another clinical study. *AgNovos's recommendation is >1 pack per day smoking and >3 alcoholic drinks per day
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
AZ Nikolaas
Sint-Niklaas, Antwerpen, 9100
Jo De Schepper, MD
About this study
Official title: Prospective, Post-market Evaluation of Safety and Efficacy of a Local Osteo- Enhancement Procedure (LOEP) in the Proximal Femur of Women in Europe with Osteoporosis
The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study. The study will collect procedural, short- and long-term data on the safety and clinical performance of AGN1 LOEP in the post-market setting in European countries where AGN1 LOEP is commercially available. AGN1 is intended to form new bone in voids in the proximal femur of women with osteoporosis.
Read the detailed description
To qualify for this study, a subject must have at least one intact hip with bone loss attributable to osteoporosis as indicated by a femoral neck DXA T-score of -2.5 or less.
Follow-up visits will be conducted at 10 days, 42 days, 12 months, and 24 months after the procedure. Study evaluations at each follow-up visit include general health (physical exam and medical history update), VAS pain (not at 10 days), FES-I (not at 10 days), EQ5D-5L and Parker Mobility. A Timed Up and Go Test is performed at the 10-day, 42-day and 12-month follow-up. Patient satisfaction with outcome of surgery will be asked at the 42-day and the 12-month follow-up. DXA scans and X-rays will be performed at 12 and 24 months.
- Conditions
- Osteoporosis
- Being tested
- AGN1 LOEP
- Keywords
- Bone mineral density, Femoral strength, Hip fracture, Local osteo-enhancement procedure, LOEP, proximal femur, RECONFIRM
- 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.
AGN1 LOEPDevice
Subjects with osteoporosis are treated with AGN1 local osteo-enhancement procedure in the proximal femur
| Study group | Role | What they receive |
|---|---|---|
| AGN1 LOEP | Other | Subjects treated with AGN1 LOEP in proximal femur Receives: Device: AGN1 LOEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral Neck Bone Mineral Density
6% increase in mean femoral neck BMD from preprocedure baseline to 12 months post-procedure of treated hips
Measured: 12 months
Primary Safety Evaluation
The incidence of all adverse events and serious adverse events occurring post-AGN1 LOEP through the 12 months follow-up period determined to be at least possibly related to the procedure and/or device.
Measured: 12 months
Secondary outcomes (3)
Total Hip Bone Mineral Density
6% increase in mean total hip BMD from preprocedure baseline to 12 months post-procedure of treated hips.
Measured: 12 months
Femoral Neck Bone Mineral Density
6% increase in mean femoral neck BMD from preprocedure baseline to 24 months post-procedure of treated hips.
Measured: 24 months
Total Hip Bone Mineral Density
6% increase in mean total hip BMD from preprocedure baseline to 24 months post-procedure of treated hips.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start5 Jul 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT05202678
- Sponsor's protocol ID
- AGN-CIP-301
- Status last verified
- Jan 2025
- First submitted
- 23 Sep 2021
- Last updated
- 31 Jan 2025
- 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 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Post-market Evaluation of Safety and Efficacy of a Local Osteo- Enhancement Procedure (LOEP) in the Proximal Femur of Women in Europe with Osteoporosis
- ClinicalTrials.gov ID
- NCT05202678
- Acronym / sponsor ID
- AGN-CIP-301
- Conditions
- Osteoporosis
- Keywords
- Bone mineral density, Femoral strength, Hip fracture, Local osteo-enhancement procedure, LOEP, proximal femur, RECONFIRM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- AgNovos Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jan 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.
The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study. The study will collect procedural, short- and long-term data on the safety and clinical performance of AGN1 LOEP in the post-market setting in European countries where AGN1 LOEP is commercially available. AGN1 is intended to form new bone in voids in the proximal femur of women with osteoporosis.
Detailed description
To qualify for this study, a subject must have at least one intact hip with bone loss attributable to osteoporosis as indicated by a femoral neck DXA T-score of -2.5 or less.
Follow-up visits will be conducted at 10 days, 42 days, 12 months, and 24 months after the procedure. Study evaluations at each follow-up visit include general health (physical exam and medical history update), VAS pain (not at 10 days), FES-I (not at 10 days), EQ5D-5L and Parker Mobility. A Timed Up and Go Test is performed at the 10-day, 42-day and 12-month follow-up. Patient satisfaction with outcome of surgery will be asked at the 42-day and the 12-month follow-up. DXA scans and X-rays will be performed at 12 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AGN1 LOEP | Other | Device: AGN1 LOEPSubjects treated with AGN1 LOEP in proximal femur |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is a postmenopausal female (at least 1-year post menses).
- Subject has bone loss in the hip attributable to osteoporosis as defined by a femoral neck DXA T-score of -2.5 or less.
- Subject has at least one hip without previous surgery or fracture.
- Subject is medically stable from any previous treatment or medical procedure in the opinion of the investigator and with an ASA score of I or II.
- Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
Key exclusion criteria (20 listed)
- Subject is less than 3 months removed from having a hip fracture repair or prosthesis or elective Total Hip Arthroplasty (THA).
- Subject has progressive increase in hip pain over the previous six (6) months that in the opinion of the Investigator suggests moderate to severe intra-articular arthritis, labral tear, extraarticular soft tissue pathology, referred pain, tumor, stress fracture or infection.
- Subject is dependent on the use of a wheelchair or is bedridden.
- Subject has albumin corrected serum calcium levels outside the normal lab range or has a pre-existing calcium metabolism disorder (e.g., hypercalcemia).
- Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min or is being treated with dialysis.
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 LOEPSubjects with osteoporosis are treated with AGN1 local osteo-enhancement procedure in the proximal femur | Device | AGN1 LOEP |
Primary outcome
Femoral Neck Bone Mineral Density
Time frame: 12 months
6% increase in mean femoral neck BMD from preprocedure baseline to 12 months post-procedure of treated hips
Primary Safety Evaluation
Time frame: 12 months
The incidence of all adverse events and serious adverse events occurring post-AGN1 LOEP through the 12 months follow-up period determined to be at least possibly related to the procedure and/or device.
3 secondary outcomes
Total Hip Bone Mineral Density
Time frame: 12 months
Femoral Neck Bone Mineral Density
Time frame: 24 months
Total Hip Bone Mineral Density
Time frame: 24 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.
- Individual participant dataSharing planned: No
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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.
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 AGN1 LOEP 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 6 inclusion and 20 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: looking for participants now, 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?
Contact Adam Lowe (+1 240 753 6500, info@agnovos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral Neck Bone Mineral Density (time frame: 12 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 31 Jan 2025.