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NCT06799143
Copley II: Long-term Outcome Follow-up Study of Osteoporotic Women Who Underwent a Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur
trial in Osteopenic Women in 12 participants. Completed in 15 April 2016.
25 February 2016
Quick facts
| Lead sponsor | AgNovos Healthcare, LLC |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 12 |
| Start date | 13 January 2016 |
| Primary completion | 25 February 2016 |
| Estimated completion | 15 April 2016 |
Conditions studied
- Osteopenic Women — all drugs for Osteopenic Women →
- Proximal Femur Fracture — all drugs for Proximal Femur Fracture →
Sponsor
AgNovos Healthcare, LLC
Who can join
56 and older, female only, with Osteopenic Women or Proximal Femur Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate longer-term (5-7 years) outcomes of the twelve (12) subjects treated with AGN1 Femoral LOEP in the clinical study "A Prospective Pilot Evaluation of Percutaneous Osteo-supplementation in the Proximal Femur of Osteoporotic Patients". Performance will be evaluated via medical history evaluation, X-ray, DXA, CT and mobility testing. The study will look at the extent to which the benefits demonstrated in the initial, baseline study were sustained over time. In this manner, it may be possible to determine the rate of change in BMD following the treatment; thereby allowing prediction of the total benefit period. In addition, this longer period of observation allows for further evaluation of the safety profile of the material in osteoporosis patients.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
AGN1 local osteo-enhancement procedure increases proximal femur volumetric bone mineral density of women with post-menopausal osteoporosis as assessed by quantitative computed tomography analysis.
Chin M, Hill R, Huber B, Howe J, et al · · 2025 · cited 1× · PMID 40297188 · DOI 10.1093/jbmrpl/ziaf036 -
The minimally invasive surgical local osteo-enhancement procedure (LOEP) to deliver a resorbable, tri-phasic calcium-based implant material to address bone loss and strengthen the proximal femur.
Goost H, De Schepper J, Rölfing JD, Aguado H, et al · · 2025 · PMID 41488884 · DOI 10.3389/fsurg.2025.1661501
Verify or expand the search:
- PubMed search for NCT06799143
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other AgNovos Healthcare, LLC trials
Trials by the same sponsor.
- NCT05966974 — GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients · completed
- NCT04835428 — STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures · NA · recruiting
- NCT04821739 — RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures · NA · recruiting
- NCT04796350 — RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures · NA · recruiting
- NCT03268356 — STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06799143 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AgNovos Healthcare, LLC
- Last refreshed: 29 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06799143.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing