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

Not Applicable

Active, not recruiting

• Conditions: Osteoporosis
• Interventions: Other: Clinical imaging is performed during the 24 and 60 month follow-up visits

• Registration Number: NCT04511364
• Lead Sponsor: AgNovos Healthcare, LLC

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-13
• Study Start: 2020-08-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 60

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• Subject was withdrawn from CONFIRM.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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AGN1 treated patients	Clinical imaging is performed during the 24 and 60 month follow-up visits	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.

Primary Outcome Measures

Name	Time	Method
Change in DXA score at 24 months	24 months	Change in DXA score of treated hip from baseline pre-AGN1 LOEP to 24 months post-treatment.

Secondary Outcome Measures

Name	Time	Method
Change in DXA score at 60 months	60 months	Change in DXA score of treated hip from pre-AGN1 LOEP to 60 months post-treatment.
Radiologic bone formation	60 months	Radiologic appearance of bone formation as assessed by X-ray at 24 and 60 months post-treatment.
Hip fracture incidence	60 months	The incidence of hip fracture on the treated side during the follow-up period through 60 months post-AGN1 LOEP treatment.

Trial Locations

Locations (1)

AZ Nikolaas; 🇧🇪 Sint-Niklaas, Belgium