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

Osteoporosis Clinical Trial

Official title:

Long-term Follow-up in Osteoporotic Women Treated With Local Osteo-Enhancement in Europe

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04511364
• Other study ID #: AGN-CIP-300
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: December 2025

Study information

• Verified date: November 2022
• Source: AgNovos Healthcare, LLC
• Contact: Adam Lowe
• Phone: 240753-6500
• Email: alowe[@]agnovos.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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• Subject was withdrawn from CONFIRM.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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Clinical imaging is performed during the 24 and 60 month follow-up visits
X-ray and DXA scan

Locations

Country	Name	City	State
Belgium	AZ Nikolaas	Sint-Niklaas

Sponsors (1)

Lead Sponsor	Collaborator
AgNovos Healthcare, LLC

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety evaluation	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.	60 months
Primary	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	Change in DXA score at 60 months	Change in DXA score of treated hip from pre-AGN1 LOEP to 60 months post-treatment.	60 months
Secondary	Hip fracture incidence	The incidence of hip fracture on the treated side during the follow-up period through 60 months post-AGN1 LOEP treatment.	60 months
Secondary	Radiologic bone formation	Radiologic appearance of bone formation as assessed by X-ray at 24 and 60 months post-treatment.	60 months