What is Osigraft?
Osigraft is a powder for suspension for implantation containing the active substance eptotermin alfa.
What is Osigraft used for?
Osigraft is used to treat tibia fractures that have not consolidated for at least nine months. It is used in cases where treatment with autologous bone grafting (transplantation of a bone taken from the patient himself, usually from the hip) has not worked or where autologous bone grafting is not possible. It must be used in patients with a formed skeleton (who have passed the growth phase).
The medicine can only be obtained with a prescription.
How is Osigraft used?
Osigraft must be used by a surgeon properly trained for its use. Immediately before use, Osigraft must be reconstituted with 2-3 ml of sterile sodium chloride injection solution; the suspension thus obtained takes on the consistency of the wet sand. The compound is then positioned by the surgeon directly on the site of the fracture, in contact with the duly prepared bone tissue. The surrounding soft tissues (muscles and skin) are subsequently closed around the implant. Generally, a single vial is sufficient, but another can be used if necessary.
How does Osigraft work?
The active ingredient in Osigraft, eptoterminaa alfa, acts on the bone structure. This is a copy of a protein called osteogenic protein 1, also known as morphogenic bone protein 7 (BMP-7), which is produced naturally by the body and which promotes the formation of new bone tissue. When applied, heptoterminaa alpha stimulates the formation of new bone tissue, contributing to the healing of fractured bone. Eptotermin alfa is produced by a method known as "recombinant DNA technology": that is, it is obtained from cells in which a gene (DNA) has been introduced that allows them to produce this substance. Eptotermin alfa acts like naturally produced BMP-7 proteins.
What studies have been carried out on Osigraft?
The most important study on Osigraft was carried out on 122 patients with unconsolidated tibial fractures treated with the medicine or autologous bone graft. The main measure of effectiveness, which was evaluated at nine months apart, was the healing of bone fracture. Healing had to be demonstrated by signs of consolidation of the fracture detected on radiological examination, clinical signs such as the presence of pain and the ability of the tibia to support the load and the need or otherwise for further treatment.
What benefit has Osigraft shown during the studies?
Osigraft proved to be as effective as autologous bone grafting, which is the standard treatment. After nine months, 81% of the patients who received Osigraft responded to treatment (complaining of less pain and showing greater ability to sustain the load), compared to 77% of patients who underwent autologous bone grafting.
What is the risk associated with Osigraft?
The most common side effects reported with Osigraft (observed in a number of patients between 1 and 10 out of 100) are erythema (skin redness), sensitivity, swelling at the implant site, and heterotopic ossification (bone formation outside the fracture area) or ossifying myositis (bone formation located inside soft tissue). For the full list of all side effects reported with Osigraft, see the Package Leaflet.
Osigraft should not be used in people who may be hypersensitive (allergic) to eptotermin alfa or collagen. Osigraft should not be used in the treatment of patients:
- from the skeleton not yet fully formed (which are still in the growth phase);
- with autoimmune disorders (diseases in which the immune system attacks a part of the body);
- with an ongoing infection at the surgical site or if there is another severe infection;
- with insufficient skin coverage (skin) or vascularization (blood supply) at the site of the fracture;
- with fractures due to other diseases (such as metabolic osteopathy or tumors);
- with tumor near the fracture site;
- subjected to chemotherapy, radiotherapy or immunosuppression.
Why has Osigraft been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Osigraft outweigh its risks for the treatment of tibial fractures resulting from trauma that have not consolidated for at least nine months, in patients with a skeleton format. in cases where autologous bone graft treatment did not work or was not possible. The Committee therefore recommended that the product be granted marketing authorization.
More information about Osigraft:
On May 17, 2001, the European Commission issued a marketing authorization valid for Osigraft, valid throughout the European Union, to Howmedica International S. de RL. The marketing authorization was renewed on 17 May 2006.
For the full EPAR for Osigraft click here.
Last update of this summary: 07-2007.
