Osteogenon in Orthopedics and Traumatology

University of Opole

Status and phase: Enrolling; Phase 4

Conditions: Patients With Fractures

Treatments: Drug: received an ossein-hydroxyapatite complex

Study type: Interventional

Funder types: Other

Identifiers

NCT07210281

P-2025-004 (Other Grant/Funding Number)

P-2025-003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Osteogenon

Experimental group

Description:

received an ossein-hydroxyapatite complex

Treatment:

Drug: received an ossein-hydroxyapatite complex

Control

No Intervention group

Description:

did not receive an ossein-hydroxyapatite complex