Patients with tibial bone defects due to resection after osteomyelitis who are undergoing bone segment transport MedDRA version: 9.1 Level: LLT Classification code 10046080 Term: Unspecified osteomyelitis involving lower leg
Conditions
Interventions
Trade Name: Forsteo
Product Name: Teriparatid
Pharmaceutical Form: Injection*
INN or Proposed INN: TERIPARATIDE
CAS Number: 52232674
Concentration unit: µg microgram(s)
Sponsors
Berufsgenossenschaftliche Unfallklinik
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age of 25 years or more • Tibial bone defects due to resection after osteomyelitis, surgery of bone segment transport according to a standard protocol • Calcium and Vitamin D treatment since distraction procedure started • Understanding of the study procedures and ability to comply with study prodedure for the entire length of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Diabetes mellitus • History of any malignant or neoplastic disease • Prior radiation therapy of the skeleton • Unsuccesfull eradication of osteomyelitis evidenced by positive culture from docking site •Severe deformities requiring three-dimensional correction procedures •Hyper- or hypoparathyroidism •Complications during surgery and lengthening period •Known allergy against teriparatid •Disease or medication influencing bone- and calcium metabolism •Pre-existing hypercalcemia •Kidney Stones •Liver function disorder •AP increased •Renal Failure •Paget's disease •Alcohol or Drug dependence •Preganancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: teriparatide treatment in patients who undergo tibial bone segment transport, will accelerate consolidation of the regenerated bone and reduce the time until the patient can weight bear.;Secondary Objective: ;Primary end point(s): Bone Mineral Density assessed by DEXA-scan | — |
Countries
Germany
Outcome results
None listed