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EXTENSION - Long-term Follow-up Study of Patients Treated With AGN1 LOEP

Primary Purpose

Osteoporosis

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Clinical imaging is performed during the 24 and 60 month follow-up visits
Sponsored by
AgNovos Healthcare, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoporosis focused on measuring local osteo-enhancement procedure, hip fracture/prevention and control, calcium phosphate, calcium sulphate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subject was withdrawn from CONFIRM.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.

Sites / Locations

  • AZ NikolaasRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AGN1 treated patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in DXA score at 60 months
Change in DXA score of treated hip from pre-AGN1 LOEP to 60 months post-treatment.
Hip fracture incidence
The incidence of hip fracture on the treated side during the follow-up period through 60 months post-AGN1 LOEP treatment.
Radiologic bone formation
Radiologic appearance of bone formation as assessed by X-ray at 24 and 60 months post-treatment.

Full Information

First Posted
August 4, 2020
Last Updated
November 28, 2022
Sponsor
AgNovos Healthcare, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04511364
Brief Title
EXTENSION - Long-term Follow-up Study of Patients Treated With AGN1 LOEP
Official Title
Long-term Follow-up in Osteoporotic Women Treated With Local Osteo-Enhancement in Europe
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AgNovos Healthcare, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
local osteo-enhancement procedure, hip fracture/prevention and control, calcium phosphate, calcium sulphate

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AGN1 treated patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical imaging is performed during the 24 and 60 month follow-up visits
Intervention Description
X-ray and DXA scan
Primary Outcome Measure Information:
Title
Change in DXA score at 24 months
Description
Change in DXA score of treated hip from baseline pre-AGN1 LOEP to 24 months post-treatment.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change in DXA score at 60 months
Description
Change in DXA score of treated hip from pre-AGN1 LOEP to 60 months post-treatment.
Time Frame
60 months
Title
Hip fracture incidence
Description
The incidence of hip fracture on the treated side during the follow-up period through 60 months post-AGN1 LOEP treatment.
Time Frame
60 months
Title
Radiologic bone formation
Description
Radiologic appearance of bone formation as assessed by X-ray at 24 and 60 months post-treatment.
Time Frame
60 months
Other Pre-specified Outcome Measures:
Title
Safety evaluation
Description
The incidence of all serious adverse events during follow-up determined to be at least possibly related to the procedure and/or device through 60 months post-AGN1 LOEP treatment.
Time Frame
60 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Lowe
Phone
240753-6500
Email
alowe@agnovos.com
First Name & Middle Initial & Last Name or Official Title & Degree
Joris Coteur
Phone
240753-6500
Email
jcoteur@agnovos.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo De Schepper, MD
Organizational Affiliation
AZ Nikolaas
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Nikolaas
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koen Bulterys

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31802158
Citation
Howe JG, Hill RS, Stroncek JD, Shaul JL, Favell D, Cheng RR, Engelke K, Genant HK, Lee DC, Keaveny TM, Bouxsein ML, Huber B. Treatment of bone loss in proximal femurs of postmenopausal osteoporotic women with AGN1 local osteo-enhancement procedure (LOEP) increases hip bone mineral density and hip strength: a long-term prospective cohort study. Osteoporos Int. 2020 May;31(5):921-929. doi: 10.1007/s00198-019-05230-0. Epub 2019 Dec 4.
Results Reference
background
PubMed Identifier
30793358
Citation
Stroncek JD, Shaul JL, Favell D, Hill RS, Huber BM, Howe JG, Bouxsein ML. In vitro injection of osteoporotic cadaveric femurs with a triphasic calcium-based implant confers immediate biomechanical integrity. J Orthop Res. 2019 Apr;37(4):908-915. doi: 10.1002/jor.24239. Epub 2019 Mar 20. Erratum In: J Orthop Res. 2023 Jul 27;:
Results Reference
background

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EXTENSION - Long-term Follow-up Study of Patients Treated With AGN1 LOEP

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