Clinical trial NCT06799143: Copley II: Long-term Outcome Follow-up Study of Osteoporotic Women Who Underwent a Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur
Official title: Follow-up Evaluation of Osteoporotic Women Who Underwent a Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteopenic Women
Proximal Femur Fracture
Keywords: LOEP
osteoporosis
femur fracture
Lead sponsor: AgNovos Healthcare, LLC
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 12
Sex: FEMALE
Minimum age (years): 56
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone Mineral Density
timeFrame: through study completion, an average of 30 days
measure: Bone Mineral Density
timeFrame: through study completion, an average of 30 days
measure: Bone Mineral Density
timeFrame: through study completion, an average of 30 days
measure: Bone Mineral Density
timeFrame: through study completion, an average of 30 days
measure: Bone Mineral Density
timeFrame: through study completion, an average of 30 days
measure: Bone Mineral Density
timeFrame: through study completion, an average of 30 days
measure: Bone Mineral Density
timeFrame: through study completion, an average of 30 days
measure: Bone Mineral Density
timeFrame: through study completion, an average of 30 days
measure: Bone Mineral Density
timeFrame: through study completion, an average of 30 days
Secondary outcomes:
measure: Subject Interview
timeFrame: through study completion, an average of 30 days
measure: Subject Interview
timeFrame: through study completion, an average of 30 days
measure: Subject Interview
timeFrame: through study completion, an average of 30 days
measure: FRAX Index Risk Assessment
timeFrame: through study completion, an average of 30 days
Other outcomes:
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