NCT04511364

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

Long-term Follow-up in Osteoporotic Women Treated with Local Osteo-Enhancement in Europe

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: AgNovos Healthcare, LLC · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
OTHER	Clinical imaging is performed during the 24 and 60 month follow-up visits	X-ray and DXA scan

Timeline

• Start date: 2020-08-28
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-08-13
• Last updated: 2025-01-31

Locations

1 site across 1 country: Belgium