NCT04511364

Brief Summary

The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP. To qualify, subjects must have previously consented, enrolled, and been treated with the AGN1 LOEP kit in CONFIRM (AgNovos Study PST-EU-101.1). Follow-up evaluations will be conducted at 24, 36, 48 and 60 months from the date the subject originally received the AGN1 LOEP treatment. Subjects will receive DXA and X-ray imaging at the 24- and 60-month follow-up visits. The 36- and 48-month follow-up evaluations will be conducted by phone. All timepoints will include general health and medical record review.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

August 4, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

August 28, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

5.3 years

First QC Date

August 4, 2020

Last Update Submit

January 29, 2025

Conditions

Osteoporosis

Keywords

local osteo-enhancement procedurehip fracture/prevention and controlcalcium phosphatecalcium sulphateLOEPCONFIRM Extension

Outcome Measures

Primary Outcomes (1)

  • Change in DXA score at 24 months

    Change in DXA score of treated hip from baseline pre-AGN1 LOEP to 24 months post-treatment.

    24 months

Secondary Outcomes (3)

  • Change in DXA score at 60 months

    60 months

  • Hip fracture incidence

    60 months

  • Radiologic bone formation

    60 months

Other Outcomes (1)

  • Safety evaluation

    60 months

Study Arms (1)

AGN1 treated patients

EXPERIMENTAL

Patients have been treated with the AGN1 LOEP kit in AgNovos study PST-EU-101.1. An X-ray and DXA scan are performed at 24 and 60 months post AGN1 LOEP treatment.

Other: Clinical imaging is performed during the 24 and 60 month follow-up visits

Interventions

Clinical imaging is performed during the 24 and 60 month follow-up visitsOTHER

X-ray and DXA scan

AGN1 treated patients

Eligibility Criteria

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

You may qualify if:

  • Subject had previously enrolled in CONFIRM and received AGN1 LOEP treatment.
  • 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 was withdrawn from CONFIRM.
  • Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Nikolaas

Sint-Niklaas, Sint-Niklaas, 9100, Belgium

Location

Related Publications (2)

  • Pajor A, Grof J, Idei M, Menyhart J, Zsolnai B. Utero-inhibin: a new substance inhibiting uterine contraction, isolated from amniotic fluid. Acta Physiol Acad Sci Hung. 1982;59(4):325-8.

    PMID: 7170985BACKGROUND

  • Harsoulis P, Ekonomou A, Leontsini M, Efthimiou E, Gerasimidis T, Vlotidis J, Sbarounis C. Fine needle aspiration biopsy cytology in the diagnosis of thyroid cancer. Acta Endocrinol Suppl (Copenh). 1984;265:50-1. doi: 10.1530/acta.0.107s0050. No abstract available.

    PMID: 6593990BACKGROUND

MeSH Terms

Conditions

OsteoporosisHip Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Jo De Schepper, MD

    AZ Nikolaas

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 13, 2020

Study Start

August 28, 2020

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)