A Phase 4 interventional study of received an ossein-hydroxyapatite complex in Patients With Fractures, sponsored by University of Opole. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by University of Opole · Phase 4, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 13 studies in Fractures, Bone with a site in Poland — 2 open to participants now, 3 under way, none of them phase 3. Fractures, Bone · Poland.
Among the 13 studies in Fractures, Bone with a site in Poland, this one is the 9th largest by planned enrollment of the 10 interventional ones that give a count, is the only one that started in 2024, is the only one in phase 4, and was the 13th registered.
724 studies on the registry are indexed under Fractures, Bone; 115 are open to participants now.
Browse Fractures, Bone studies →2 of the 13 studies in Fractures, Bone with a site in Poland are open now. Recruiting first, the newest first:
Rigshospitalet, Denmark · Sites in Poland, Argentina, Austria and 33 more countries
Ages 16+
A study can be open while its sites in Poland have not opened yet or have stopped. Only those recruiting at a site in Poland →
Of the 71 Fractures, Bone studies recruiting now, 36 (51%) set no upper age limit and 21 (30%) stop at 75 or younger; 17 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 6 · Phase 4 1
First in 1994; this study’s year is marked. 1 started in 2024.
This study's planned enrollment of 150 is above the median of 80 across 458 interventional studies indexed under Fractures, Bone.
Median enrollment 387 across the 10 interventional studies, 222 across the 3 observational. Of the 9 that completed or were terminated, 6 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 13 have an industry lead sponsor. The 10 most frequent:
University of Opole is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
University of Opole has 1 study filed under Fractures, Bone — fewer than ten, so there is no comparison to draw.
2 of the studies in Fractures, Bone with a site in Poland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06450639Hoffmann-La RocheA Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) | 2026-11-18 |
| NCT07210281University of OpoleOsteogenon in Orthopedics and Traumatology | 2027-02-02 |
Add all 2 to your calendar (.ics) → With an account.
Among the 13 studies in Fractures, Bone with a site in Poland, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
The role of ossein-hydroxyapatite complex in fracture healing requires further research.
The aim of the study was to evaluate the effect of ossein-hydroxyapatite complex (Osteogenon) as an adjunctive treatment on the outcome of conservative and surgical fractures treatment via comprehensive clinical, radiological and biomechanical assessments. The investigators aimed to reject the null hypothesis of the absence of beneficial effect of ossein-hydroxyapatite complex on fractures treatment outcomes. This would fill the existing gap in the scientific literature and enable a more widespread use of Osteogenon in the treatment of fractures in many trauma centers.
Patients in the study group with fractures received an ossein-hydroxyapatite complex (830 milligram [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.
The drug Osteogenon used in our study had been approved for fracture treatment. The study was conducted in accordance with the Declaration of Helsinki and all applicable laws and regulations. All patients had provided their written informed consent and were informed of a voluntary nature of their participation in this study.
Patients participating in the study, both in the study and control groups, had to meet the inclusion criteria. The randomization method used was to evenly recruit the study and control groups as patients who met the inclusion criteria were recruited. Randomization took into account the equal distribution of gender and age in both groups.
Patients from both the experimental and control groups received the same recommendations regarding rehabilitation and had the same clinical and radiological follow-up protocol.
The following clinical, biomechanical and radiological parameters were assessed in the study: the period of immobilization, rate of bone union, analgesic use at the beginning of treatment, analgesic use during the follow-up, time to achieving pain relief, pain in 100 millimeter [mm] Visual Analogue Scale (VAS), number of patients declaring pain relief, rate of complications, time to resuming normal physical activity, grip strength, muscle strength during joint movement.
The period of immobilization was defined as the total number of days during which cast immobilization was maintained. The time to resuming normal physical activity was expressed in days and defined as the period from injury to return to work or school and normal everyday activities.
The rate of bone union was determined based on the percentage of patients who achieved clinical and radiological criteria of bone union. The radiological criteria of bone union were the presence of a minimum of 3 out of 4 consolidated cortical bone layers or trabecular transition between bone fragments on X-rays in 2 views. Clinical bone union was defined as the lack of pathological mobility, pain, or deformity during attempts to perform movements in the wrist area at the fracture site. Nonunion was defined as failure to meet the above criteria for 6 months after the fracture .
The investigators also assessed the number of patients on any analgesics (paracetamol, ibuprofen, non-steroidal anti-inflammatory drugs, tramadol) at the beginning of treatment and at the final follow-up. During regular follow-up visits, patients were asked about their pain intensity using the NRS (Numerical Rating Scale). A period of discontinuation of any pain medication was equivalent to a patient rating their pain level as 0 on the NRS. Time to achieving pain relief was expressed in days and defined as the period from the beginning to end of taking any analgesic drugs.
Complications were assessed based on medical and radiological records. The evaluated complications included nonunion, delayed bone union, fragment displacement, persistent pain, persistent swelling, limited range of motion, vascular damage, nerve damage, the need for revision surgery or repeated reduction and immobilization.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
received an ossein-hydroxyapatite complex
Drug: received an ossein-hydroxyapatite complex
did not receive an ossein-hydroxyapatite complex
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.
period of bone union
assessed by data linkage to medical and radiological records
Time frame: at 6 months after randomisation
Achieving bone union
assessed by data linkage to medical and radiological records
Time frame: at 6 months after randomisation
pain assessment
100mm Visual Analogue Scale (VAS) * 0 mm indicates "no pain" * 100 mm indicates "worst imaginable pain" * Higher scores on the VAS indicate a worse outcome (greater pain intensity).
Time frame: at 6 months after randomisation
Plan to share: No — 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.
Started Nov 2024 (actual). Primary completion is estimated for Feb 2027, 27 months after the start.
Of 19 phase 4 interventional studies under Fractures, Bone, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 75. This study's planned 27 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Opole