NCT04543682 (Ilobone) is a Phase 1/Phase 2 clinical trial of 0.125 ng/kg/min Iloprost in Proximal Humeral Fracture, sponsored by Charite University, Berlin, Germany.

Who is sponsoring NCT04543682?

NCT04543682 is sponsored by Charite University, Berlin, Germany.

What drugs are being tested in NCT04543682?

Interventions in NCT04543682: 0.125 ng/kg/min Iloprost, 0.25 ng/kg/min Iloprost, open reduction and internal fixation with an angular stable plate (PHILOS).

What condition does NCT04543682 study?

NCT04543682 studies Proximal Humeral Fracture.

Is NCT04543682 still recruiting?

NCT04543682 is currently status unknown. Last updated 31 October 2022.

Last reviewed 2022-10-31 · How we verify

NCT04543682: Ilobone

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase I/IIa, Prospective, Mono-center, Randomized, Open Labeled, Controlled Study to Assess the Safety and Efficacy of Applying Iloprost Locally in the Fracture Site to Promote Bone Healing in Patients With Proximal Humeral Fracture

Status unknown Phase 1/Phase 2 Last updated 31 October 2022

What this trial tests

Phase 1/Phase 2 trial testing 0.125 ng/kg/min Iloprost in Proximal Humeral Fracture in 30 participants. Status unknown.

Timeline

12 May 2022

Primary endpoint
1 May 2024

1 December 2024

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	Phase 1/Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	12 May 2022
Primary completion	1 May 2024
Estimated completion	1 December 2024
Sites	1 location across Germany

Drugs / interventions tested

0.125 ng/kg/min Iloprost — full drug profile →
0.25 ng/kg/min Iloprost — full drug profile →
open reduction and internal fixation with an angular stable plate (PHILOS)

Conditions studied

Proximal Humeral Fracture — all drugs for Proximal Humeral Fracture →

Sponsor

Charite University, Berlin, Germany

Who can join

Adults 60 to 80, any sex, with Proximal Humeral Fracture. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Toxicity grading in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time frame: 12 months
Toxicity grading in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Efficacy analysis using the Tip Apex Distance (TAD) readout
Time frame: 12 weeks after surgery
TAD is an indicator of the progress of fracture healing and the probability of potential complications. Thus, it reflects both the safety and efficacy of the investigational treatment. To evaluate the treatment success rate, we will calculate the percentage loss of the summation of TADs of all locking screws. The value will be classified into one of five ranks as measured after 12 weeks of postope

Sponsor's own description

The main objective of this study is to establish the safety as well as the efficacy of local insertion of Iloprost at the fracture site for bone healing of the proximal humeral fracture. The study will have two treatment groups and one control group. All patients will receive the standard of care procedure (reduction and angular stable (PHILOS) plate fixation). The two treatment groups will additionally be treated with two different Iloprost doses. Subjects will be assessed for study eligibility within 24h after admission (screening period). Eligible subjects will be assessed for baseline parameters on day 0. Within 96 hours of the study, subjects will undergo surgery, reduction, and angular stable (PHILOS) plate fixation. During the procedure, a catheter will be inserted in the fracture site of the treatment groups in order to deliver the Iloprost locally in the fracture site. The expected total duration of study participation for each subject comprises 52 weeks, among which 26 weeks include active study participation. At the study end, a telephone call with the subjects will be performed for safety assessment. Recruitment will be completed in approximately 18 months. Follow up visits following the surgical operation shall take place during weeks 3, 6, 12, and 26. The last follow-up will be a phone call during week 52 for the purpose of safety assessment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

ILOBONE: A phase I/IIa randomized controlled trial to assess the safety and feasibility of local iloprost therapy for enhancing proximal humerus fracture healing- a pilot study design.
Elazaly H, Dimitriou IM, Maleitzke T, Dahne M, et al · · 2025 · cited 2× · PMID 40405317 · DOI 10.1186/s13018-025-05865-2
ILOBONE: A phase I/IIa randomized controlled trial to assess the safety and feasibility of local iloprost therapy for enhancing proximal humerus fracture healing – a pilot study design
Elazaly H, Dimitriou IM, Maleitzke T, Dahne M, et al · · 2025 · DOI 10.21203/rs.3.rs-6056916/v1

Verify or expand the search:

Other recruiting trials for Proximal Humeral Fracture

Currently open trials in the same condition.

NCT06416618 — Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years · NA · recruiting
NCT05703958 — Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up · recruiting
NCT06444828 — Comparing Outcomes of Non-surgical Versus Surgical Treatment of Shoulder Fractures With Different Shoulder Replacements · NA · active not recruiting
NCT06133920 — Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures · recruiting
NCT04523415 — Researches About Proximal Humerus Fractures · recruiting

Other Charite University, Berlin, Germany trials

Trials by the same sponsor.

NCT07486167 — Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congeni · Phase 1, PHASE2 · not yet recruiting
NCT07476729 — International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020) · Phase 3 · not yet recruiting
NCT07503054 — Ovarian Cancer Screening and AI · NA · not yet recruiting
NCT07529197 — Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious ME/CFS · recruiting
NCT07388693 — Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04543682 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 20 May 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 Charite University, Berlin, Germany
Last refreshed: 31 October 2022

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/NCT04543682.