Copley II: Long-term Outcome Follow-up Study of Osteoporotic Women Who Underwent a Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur

NCT ID: NCT06799143

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-13
• Study Completion Date: 2016-04-15

Brief Summary

To evaluate longer-term (5-7 years) outcomes of the twelve (12) subjects treated with AGN1 Femoral LOEP in the clinical study "A Prospective Pilot Evaluation of Percutaneous Osteo-supplementation in the Proximal Femur of Osteoporotic Patients". Performance will be evaluated via medical history evaluation, X-ray, DXA, CT and mobility testing.

The study will look at the extent to which the benefits demonstrated in the initial, baseline study were sustained over time. In this manner, it may be possible to determine the rate of change in BMD following the treatment; thereby allowing prediction of the total benefit period. In addition, this longer period of observation allows for further evaluation of the safety profile of the material in osteoporosis patients.

Detailed Description

This observational single arm study will be broken into two parts:

1. A retrospective component which will evaluate the original FRAX score along with any events or medications received after the end of the original study.

2. A prospective component which will evaluate longer term outcomes following the use of the AGN1 synthetic bone graft material in a local osteoenhancement procedure through evaluation of mobility and imaging.

In the original study, subjects completed a twenty-four (24) month follow-up visit after receiving a unilateral hip injection with the device. The contralateral hip acted as the control. The purpose of the study was to determine the safety of the injection as well as the initial improvement in femoral bone density in a twenty-four (24) month period.

In this follow-up study the subjects, after signing the informed consent form, will complete a short medical history (focused on their osteoporosis management) and a mobility test.

Subjects will also undergo a DXA, X-ray and CT scans of both hips.

Conditions

Osteopenic Women; Proximal Femur Fracture

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• participated in the original study and signed the consent form
• received treatment with AGN1 Femoral LOEP
• completed the study.

• Minimum Eligible Age: 56 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AgNovos Healthcare, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PRE-US-101.0

Identifier Type: -

Identifier Source: org_study_id