NCT02916953

Brief Summary

The study will evaluate the immediate procedure and post-procedure profile of the AGN1 Femoral LOEP™ Kit. All subjects will receive the treatment and be evaluated for any adverse or serious adverse events that could occur during the procedure or immediately post-procedure.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 17, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

4.5 years

First QC Date

September 26, 2016

Last Update Submit

November 28, 2022

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Number of participants with procedure-related or device-related adverse events

    Adverse Events and Serious Adverse Events related to either the treatment or device. The incidence of all adverse events occurring during the first forty-two (42) day follow-up period determined to be at least possibly related to the procedure and/or device for the local treatment of osteoporosis.

    42 Days

Study Arms (1)

Treatment

EXPERIMENTAL

All subjects who meet the inclusion and exclusion criteria will receive the AGN1 Femoral Local Osteo-Enhancement Procedure (LOEP™) treatment

Device: AGN1 Femoral Local Osteo-Enhancement Procedure

Interventions

AGN1 Femoral Local Osteo-Enhancement ProcedureDEVICE

A procedure that is intended to increase the strength of the proximal femur in individuals with osteoporosis of the femoral neck. Local treatment of the proximal femur with AGN1 is intended to be adjunctive to appropriate systemic therapy and overall osteoporosis management as directed by the patient's treating physicians.

Also known as: AGN1 Femoral LOEP™
Treatment

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is postmenopausal female (at least 1-year post menses).
  • Subject has osteoporosis as defined by a documented DXA scan T score of ≤ -2.5 in the femoral neck of at least one hip within the last year. If no documented T-score, then a DXA scan will be performed during eligibility screening.
  • Subject has one hip without previous surgery or fracture.
  • Subject is medically stable from any previous treatment or medical procedure in the opinion of the investigator and with an ASA score of I or II.
  • Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
  • Subject is capable of giving written informed consent to participate in the study.

You may not qualify if:

  • Subject is less than six (6) months removed from having a hip fracture repair or prosthesis, or less than three (3) months removed from an elective THA.
  • Subject has progressive increase in undiagnosed hip pain over the previous six months that in the opinion of the Investigator may suggest other underlying bone or joint pathology (e.g. rheumatoid arthritis, fracture, etc.).
  • Subject is dependent on the use of a wheel-chair or is bed-ridden.
  • Subject has albumin corrected serum calcium levels outside the normal lab range or has a pre-existing calcium metabolism disorder (e.g. hypercalcemia).
  • Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) ≤ 30 mL/min or is being treated with dialysis.
  • Subject has insulin-dependent diabetes mellitus (IDDM).
  • Subject has Body Mass Index (BMI) \> 35.
  • 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, including signs predictive of atypical femoral fractures (e.g. Cortical beaking) or has been diagnosed and/or treated for atypical femoral fractures.
  • 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 (ex. 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

AZ Sint-Blasius

Dendermonde, 9200, Belgium

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

AZ Groeninge - Campus Kennedylaan

Kortrijk, 8500, Belgium

Location

AZ Sint-Nikolaas

Sint-Niklaas, 9110, Belgium

Location

Maastricht UMC

Maastricht, 6229, Netherlands

Location

Related Publications (4)

  • International Osteoporosis Foundation. Facts and Statistics. 2013: http://www.iofbonehealth.org/facts-statistics.

    BACKGROUND

  • MacLean C, Newberry S, Maglione M, McMahon M, Ranganath V, Suttorp M, Mojica W, Timmer M, Alexander A, McNamara M, Desai SB, Zhou A, Chen S, Carter J, Tringale C, Valentine D, Johnsen B, Grossman J. Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med. 2008 Feb 5;148(3):197-213. doi: 10.7326/0003-4819-148-3-200802050-00198. Epub 2007 Dec 17.

    PMID: 18087050BACKGROUND

  • Abrahamsen B, van Staa T, Ariely R, Olson M, Cooper C. Excess mortality following hip fracture: a systematic epidemiological review. Osteoporos Int. 2009 Oct;20(10):1633-50. doi: 10.1007/s00198-009-0920-3. Epub 2009 May 7.

    PMID: 19421703BACKGROUND

  • Kanis JA, Oden A, Johansson H, Borgstrom F, Strom O, McCloskey E. FRAX and its applications to clinical practice. Bone. 2009 May;44(5):734-43. doi: 10.1016/j.bone.2009.01.373. Epub 2009 Feb 3.

    PMID: 19195497BACKGROUND

Related Links

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jo De Schepper, MD

    AZ Nikolaas

    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

September 26, 2016

First Posted

September 28, 2016

Study Start

December 17, 2016

Primary Completion

June 1, 2021

Study Completion

April 1, 2022

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations

BE(4)NL(1)