Osteogenon to support healing in adults with bone fractures.
The Use of Ossein-hydroxyapatite Complex as an Adjunctive Treatment in Orthopedics and Traumatology
This tests whether taking Osteogenon tablets twice daily helps adults with fractures heal faster and with stronger bone recovery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Opole Academic / other |
| Locations | 1 site (Opole, Opole Voivodeship) |
| Trial ID | NCT07210281 on ClinicalTrials.gov |
What this trial studies
The trial randomized adults with distal radius or lower leg fractures to receive standard surgical or conservative fracture care with or without the ossein-hydroxyapatite complex (Osteogenon) taken orally at one 830 mg tablet twice daily until healing. Outcomes included clinical examinations, radiographic imaging and biomechanical measures to compare time to union and bone quality, with at least three months of follow-up. Eligible patients were screened to exclude factors that affect bone remodeling and those taking interacting medications. The study was conducted at the University Clinical Hospital in Opole under approved ethical standards and written informed consent.
Who should consider this trial
Good fit: Adults aged 18–85 with acute fractures treated surgically or non-surgically, without comorbidities or medications that impair bone healing and able to attend follow-up visits, are the intended participants.
Not a fit: People with severe renal failure or dialysis, hypercalcemia, calcium-based kidney stones, hypersensitivity to the drug, children under 18, or those taking medications that affect bone remodeling are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, Osteogenon could shorten healing time and improve bone strength after fractures, potentially reducing complications and speeding return to function.
How similar studies have performed: Osteogenon (ossein-hydroxyapatite complex) has been used clinically and some small studies suggest benefit for bone healing, but high-quality randomized evidence is limited and results are mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * post-inflammatory deformities
Where this trial is running
Opole, Opole Voivodeship
- University Clinical Hospital in Opole — Opole, Opole Voivodeship, Poland (Recruiting)
Study contacts
- Study coordinator: Piotr Morasiewicz, PROF
- Email: piotr.morasiewicz@uni.opole.pl
- Phone: +48504549666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.