EXTENSION - Long-term Follow-up Study of Patients Treated With AGN1 LOEP

Study Overview
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Brief Summary
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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.

Official Title
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Long-term Follow-up in Osteoporotic Women Treated With Local Osteo-Enhancement in Europe

Conditions
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Osteoporosis

Intervention / Treatment
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* Other: Clinical imaging is performed during the 24 and 60 month follow-up visits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Subject was withdrawn from CONFIRM.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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN1 treated patients<br>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. | Other: Clinical imaging is performed during the 24 and 60 month follow-up visits<br>* X-ray and DXA scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in DXA score at 24 months | Change in DXA score of treated hip from baseline pre-AGN1 LOEP to 24 months post-treatment. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in DXA score at 60 months | Change in DXA score of treated hip from pre-AGN1 LOEP to 60 months post-treatment. | 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. | 60 months | 
| Radiologic bone formation | Radiologic appearance of bone formation as assessed by X-ray at 24 and 60 months post-treatment. | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local osteo-enhancement procedure, hip fracture/prevention and control, calcium phosphate, calcium sulphate