STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture

NCT03268356 | Completed

• 1 other identifier: PST-HK-100.1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the procedure and safety profile of the AGN1 Femoral LOEP Kit. This pilot study will be used to evaluate AGN1 Femoral LOEP treatment in a contralateral proximal femur during hip fracture repair.

Conditions

Hip Fractures; Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment or Device Emergent Serious Adverse Events

  Incidence of all serious adverse events (SAEs) occurring from the day of procedure through the twenty-four (24) month follow-up period determined to be definitely related to Femoral LOEP and/or the AGN1 device.

  24 Months

Secondary Outcomes (4)

• Incidence of Non-Treatment Emergent Fragility Fractures

  24 Months

• Incidence of Treatment or Device Emergent Adverse Events

  24 Months

• Change in Bone Mineral Density between Baseline and 12 Months

  12 Months

• Change in Bone Mineral Density between Baseline and 24 Months

  24 Months

Study Arms (1)

AGN1 Treatment

OTHER

Subjects who have suffered a fragility hip fracture in one hip, sign the consent form and meet the inclusion and none of the exclusion of the study will receive the AGN1 Femoral Local Osteo-Enhancement Procedure (LOEP™) in the non-fractured hip.

Device: AGN1 Femoral Local Osteo-Enhancement Procedure Kit

Interventions

AGN1 Femoral Local Osteo-Enhancement Procedure Kit DEVICE

A procedure that is intended to replace lost bone and increase the strength of the proximal femur in individuals with osteoporosis of the femoral neck.

Also known as: AGN1 Femoral LOEP™

AGN1 Treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Subject is a postmenopausal female
• Subject has a low-energy fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.
• Subject is ≥ 65 years of age.
• Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study.
• Subject is capable of giving written informed consent to participate in the study.

You may not qualify if:

• Subject has a prior diagnosis of secondary osteoporosis.
• Subject has history of any hip surgery or previous hip fracture in the non-fractured hip.
• Subject has progressive increase in undiagnosed hip pain over the previous six (6) months that in the opinion of the Investigator may suggest other underlying bone or joint pathology (e.g. osteoarthritis, fracture, etc.).
• Subject has serum calcium levels outside the normal lab range as per local guidelines and reference ranges.
• Subject has moderate to severe renal insufficiency as per local guidelines and reference ranges.
• Subject has insulin-dependent diabetes mellitus (IDDM).
• Subject has Body Mass Index (BMI) \> 30.
• Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator\*.
• Subject exhibits excessive alcohol consumption as determined by the principal investigator\*.
• Subject has radiological evidence of gross bony or joint pathology of the non-fractured hip.
• Subject treated with corticosteroids or systemic glucocorticoids for ten (10) days in the previous six (6) months.
• Subject has history of oral or parenteral use of immune-suppressive drugs in the previous twelve months.
• Subject has history of metabolic bone disease other than osteoporosis (eg. Paget's disease).
• Subject has a history of auto-immune arthritic diseases including rheumatoid, psoriatic, or those associated with systemic lupus erythematosus, spondyloarthropathy, Reiter's Syndrome or Crohn's Disease.
• Subject has a history of radiation therapy to the hip or pelvic region.

Sponsors & Collaborators

• AgNovos Healthcare, LLC: lead

Study Sites (1)

Queen Mary Hospital - Department of Orthopaedics and Traumatology

Hong Kong, Hong Kong

Location

Related Links

• Company website

MeSH Terms

Conditions

Hip Fractures; Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

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

Study Officials

• Christian Fang, MD

  Queen Mary Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 31, 2017
• Study Start: August 15, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)