Proximal humeral fractures in postmenopausal women over 50 years of age. In this study we want to examine if teriparatide improves increased callus formation (jugded by blinded investigators) and if this improves the function and decreases the pain at 7 weeks and 3 months.
Conditions
Interventions
Trade Name: Forsteo
Pharmaceutical Form: Injection*
Sponsors
Department of Orthopaedics IKE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Females 50 years or older 2. Proximal humeral fracture 3. Ability to give informed consent 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: Rheumatic disease Reduced renal function - plasma creatinine > 125 mmol/L History of allergic reaction to the drug Hypercalcemia Metabolic diseases affecting the bone Malignancy Previous radiation therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does teriparatide increase callus formation in proximal humeral fractures?;Secondary Objective: If increased callus formation is seen, as a sign of improved healing rate, does this improve the function and decrease the pain for the patients?;Primary end point(s): Two doctors, blinded to the treatment (patients randomised to Forsteo versus no medical treatment), will judge from x-rays at 7 weeks and 3 month whether normal or "increased" callus formation is seen. They have to reach a consensus. Their judgement will be compared with the treatment and analysed using Chi2-test. | — |
Countries
Sweden
Outcome results
None listed