NCT07210281

Brief Summary

The aim of this study was to evaluate the supportive effect of the ossein-hydroxyapatite complex in fracture healing. The investigators hypothesized that the ossein-hydroxyapatite complex would positively impact fracture healing outcomes.The assessment covers clinical, radiological and biomechanical parameters.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
20mo left

Started Nov 2024

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
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

Study Progress48%
Nov 2024Dec 2027

Study Start

First participant enrolled

November 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

2.3 years

First QC Date

September 29, 2025

Last Update Submit

November 22, 2025

Conditions

Patients With Fractures

Keywords

fracturesOsteogenonossein-hydroxyapatite complexdistal radius fractureslower leg fractureproximal humerus fractures

Outcome Measures

Primary Outcomes (2)

  • period of bone union

    assessed by data linkage to medical and radiological records

    at 6 months after randomisation

  • Achieving bone union

    assessed by data linkage to medical and radiological records

    at 6 months after randomisation

Secondary Outcomes (1)

  • pain assessment

    at 6 months after randomisation

Study Arms (2)

Osteogenon

EXPERIMENTAL

received an ossein-hydroxyapatite complex

Drug: received an ossein-hydroxyapatite complex

Control

NO INTERVENTION

did not receive an ossein-hydroxyapatite complex

Interventions

received an ossein-hydroxyapatite complexDRUG

Patients in the study group with fractures received an ossein-hydroxyapatite complex (830 mg of ossein-and-hydroxyapatite complex, with 444 mg of hydroxyapatite, equivalent to 178 mg of calcium and 82 mg of phosphorus) throughout the entire period following fracture healing. The tablets were taken orally, one tablet twice daily.

Osteogenon

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • no contraindications to taking Osteogenon
  • a follow-up period of more than 3 months after treatment completion
  • complete medical and radiological records
  • a written informed consent
  • not taking any other medications that could affect bone tissue remodeling
  • not taking other medications that interact with Osteogenon
  • no other limb pathologies (inflammatory or neurogenic)
  • absence of comorbidities that could affect bone union

You may not qualify if:

  • age under 18 years or over 85 years
  • hypersensitivity to the active ingredient or to any of the excipients
  • severe renal failure and dialysis therapy
  • hypercalcemia
  • hypercalciuria
  • calcium-based kidney stones or tissue calcifications
  • a follow-up period shorter than 3 months after treatment completion
  • a lack of informed consent
  • a lack of cooperation with the patient
  • absent or incomplete medical and radiological records
  • taking medications that could affect bone tissue remodeling
  • taking medications that may interact with Osteogenon (e.g. thiazide diuretics)
  • metabolic disorders
  • post-traumatic skeletal deformities
  • neuromuscular disorders
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Hospital in Opole

Opole, Opole Voivodeship, 46-020, Poland

RECRUITING

Related Publications (2)

  • Morasiewicz P, Zaborska M, Sobczak M, Tomczyk L, Leyko P, Bobinski A, Kochanska-Bieri J, Pili D, Kazubski K. The Use of Osteogenon as an Adjunctive Treatment in Lower Leg Fractures. Pharmaceuticals (Basel). 2024 Nov 14;17(11):1531. doi: 10.3390/ph17111531.

    PMID: 39598441BACKGROUND

  • Morasiewicz P, Zaborska M, Sobczak M, Tomczyk L, Pili D, Kazubski K, Leyko P. The Use of Ossein-Hydroxyapatite Complex in Conjunction with the Ilizarov Method in the Treatment of Tibial Nonunion. J Clin Med. 2025 May 12;14(10):3353. doi: 10.3390/jcm14103353.

    PMID: 40429349BACKGROUND

MeSH Terms

Conditions

Fractures, BoneWrist Fractures

Condition Hierarchy (Ancestors)

Wounds and InjuriesWrist InjuriesArm Injuries

Study Officials

  • Marek Gierlotka, PROF

    University of Opole

    STUDY CHAIR

Central Study Contacts

Piotr Morasiewicz, PROF

CONTACT

+48504549666piotr.morasiewicz@uni.opole.pl

Monika Zaborska

CONTACT

+48692706595zaborska.monika.pl@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 29, 2025

First Posted

October 7, 2025

Study Start

November 1, 2024

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

The data collected during our study are our own efforts and will be used to prepare our publications. Other authors are encouraged to conduct their own research.

Locations

PL(1)