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New treatment option for Patients With Fractures
Official title Osteogenon in Orthopedics and Traumatology
ClinicalTrials.gov ID: NCT07210281
What this study is testing
What is received an ossein-hydroxyapatite complex?
received an ossein-hydroxyapatite complex is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for patients with fractures.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Opole, Opole Voivodeship, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Opole, Opole Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.