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

NCT06799143 | Completed

• 1 other identifier: PRE-US-101.0
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteopenic Women; Proximal Femur Fracture

Keywords

LOEP; osteoporosis; femur fracture

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• Subject Interview

  through study completion, an average of 30 days

• Subject Interview

  through study completion, an average of 30 days

• Subject Interview

  through study completion, an average of 30 days

• FRAX Index Risk Assessment

  through study completion, an average of 30 days

Eligibility Criteria

• Age: 56 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• AgNovos Healthcare, LLC: lead

MeSH Terms

Conditions

Proximal Femoral Fractures; Osteoporosis; Femoral Fractures

Condition Hierarchy (Ancestors)

Femoral Neck Fractures; Hip Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 29, 2025
• Study Start: January 13, 2016
• Primary Completion: February 25, 2016
• Study Completion: April 15, 2016
• Last Updated: January 29, 2025

Record last verified: 2025-01