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NCT Number: NCT06799143

Copley II: Long-term Outcome Follow-up Study 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.

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Key information

Conditions

Osteopenic Women Bone Diseases Bone Diseases, Metabolic Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Proximal Femoral Fractures Proximal Femur Fracture Wounds and Injuries

Age range

56 year and older

Sex eligibility

Female

Study type

Observational

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Bone Mineral Density

    Time frame: through study completion, an average of 30 days

    Bone mineral density (BMD) assessed by DXA scans (T-score ) of the treated hip compared to nontreated hip (femoral neck).

  2. Bone Mineral Density

    Time frame: through study completion, an average of 30 days

    Bone mineral density (BMD) assessed by DXA scans (absolute value measurement) of the treated hip compared to nontreated hip (femoral neck).

  3. Bone Mineral Density

    Time frame: through study completion, an average of 30 days

    Percent change compared to baseline for the treated femoral neck measurement of BMD.

  4. Bone Mineral Density

    Time frame: through study completion, an average of 30 days

    Percent change compared to baseline for the untreated femoral neck measurement of BMD.

  5. Bone Mineral Density

    Time frame: through study completion, an average of 30 days

    Bilateral hip CT scan analysis of the trabecular bone density.

  6. Bone Mineral Density

    Time frame: through study completion, an average of 30 days

    Bilateral hip CT scan analysis of the trabecular bone volume.

  7. Bone Mineral Density

    Time frame: through study completion, an average of 30 days

    Bilateral hip CT scan analysis of the cortical bone density.

  8. Bone Mineral Density

    Time frame: through study completion, an average of 30 days

    Bilateral hip CT scan analysis of the cortical bone volume.

  9. Bone Mineral Density

    Time frame: through study completion, an average of 30 days

    Bilateral hip CT scan analysis of any qualitative observations compared to baseline CT scans.

Secondary outcomes

  1. Subject Interview

    Time frame: through study completion, an average of 30 days

    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.

  2. Subject Interview

    Time frame: through study completion, an average of 30 days

    All osteoporosis medication use including vitamins and supplements from the twenty-four (24) month follow-up visit to current point-in-time.

  3. Subject Interview

    Time frame: through study completion, an average of 30 days

    Any physical activity/exercise program from the twenty-four (24) month follow-up visit to current point-in-time.

  4. FRAX Index Risk Assessment

    Time frame: through study completion, an average of 30 days

    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.

Sponsors and collaborators

Lead sponsor

AgNovos Healthcare, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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