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

AgNovos

Status: Active, not recruiting

Conditions: Osteoporosis

Treatments: Other: Clinical imaging is performed during the 24 and 60 month follow-up visits

Study type: Interventional

Funder types: Industry

Identifiers

NCT04511364

AGN-CIP-300

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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• Subject was withdrawn from CONFIRM.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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

AGN1 treated patients

Experimental group

Description:

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.

Treatment:

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