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

Follow-up Evaluation of Osteoporotic Women Who Underwent a Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur

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.

Study Overview

• Status: Completed
• Conditions: Proximal Femur Fracture; Osteopenic Women

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.

• Study Type: Observational
• Enrollment (Actual): 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Females aged 56 or older and menses have ceased for at least one year. Subjects that were participants in the original study that signed a consent form, received treatment with AGN1 Femoral LOEP and completed the original study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• There is no exclusion criteria for this study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Mineral Density	Bone mineral density (BMD) assessed by DXA scans (T-score ) of the treated hip compared to nontreated hip (femoral neck).	through study completion, an average of 30 days
Bone Mineral Density	Bone mineral density (BMD) assessed by DXA scans (absolute value measurement) of the treated hip compared to nontreated hip (femoral neck).	through study completion, an average of 30 days
Bone Mineral Density	Percent change compared to baseline for the treated femoral neck measurement of BMD.	through study completion, an average of 30 days
Bone Mineral Density	Percent change compared to baseline for the untreated femoral neck measurement of BMD.	through study completion, an average of 30 days
Bone Mineral Density	Bilateral hip CT scan analysis of the trabecular bone density.	through study completion, an average of 30 days
Bone Mineral Density	Bilateral hip CT scan analysis of the trabecular bone volume.	through study completion, an average of 30 days
Bone Mineral Density	Bilateral hip CT scan analysis of the cortical bone density.	through study completion, an average of 30 days
Bone Mineral Density	Bilateral hip CT scan analysis of the cortical bone volume.	through study completion, an average of 30 days
Bone Mineral Density	Bilateral hip CT scan analysis of any qualitative observations compared to baseline CT scans.	through study completion, an average of 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Interview	All osteoporosis related events (as defined by the Investigator) from the twenty-four (24) month follow-up visit to current point-in-time including fragility fractures, changes in mobility and medication reactions.	through study completion, an average of 30 days
Subject Interview	All osteoporosis medication use including vitamins and supplements from the twenty-four (24) month follow-up visit to current point-in-time.	through study completion, an average of 30 days
Subject Interview	Any physical activity/exercise program from the twenty-four (24) month follow-up visit to current point-in-time.	through study completion, an average of 30 days
FRAX Index Risk Assessment	Comparative calculation of a FRAX index for hip fracture risk based on BMD data from the treatment and contralateral hip using pre-procedure data compared to current point-in-time.	through study completion, an average of 30 days

Collaborators and Investigators

• Sponsor: AgNovos Healthcare, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2016
• Primary Completion (Actual): February 25, 2016
• Study Completion (Actual): April 15, 2016

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: osteoporosis; femur fracture; LOEP
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures
• Other Study ID Numbers: PRE-US-101.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No