postoperative osteoporotic intertrochanteric fracture in elderly Hip fracture, elderly, denosumab, osteoporosis, functional recovery
Conditions
Interventions
Denosumab 60mg prepared in 1ml syringe subcutaneously injection single dose,Normal saline solution 1ml prepared in 1ml syringe identical to denosumab group subcutaneously injection single dose
Experimental Drug,Placebo Comparator No treatment
Denosumab,Placebo
Sponsors
Mahidol University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patient age equal or greater than 60 years old 2. Intertrochanteric fracture patient following low energy mechanism of injury and treated by internal fixation either cephalomedullay nail or dynamic hip screw 3. Proximal femoral fracture in trochanteric region defined as 31A by AO classification
Exclusion criteria
Exclusion criteria: 1. Patient who has early postoperative complication within 2 weeks after surgical treatment with internal fixation such as wound infection, iatrogenic fracture 2. Patient who cannot participate in weight bearing rehabilitation program or prohibited by surgeon 3. Multiple fractures 4. Multiple injuries 5. Pathological fracture caused by primary or secondary bone tumor classified as malignancy confirmed by pathology report 6. Contraindication to denosumab such as chronic kidney disease with glomerular filtration rate less than 15 ml/min, drug hypersensitivity, hypocalcemia with serum calcium less than 9.0 mg/dL 7. Recent prescribed medication 6 months prior to fracture with denosumab, parathyroid hormone analogue, and high dose glucocorticoids more than 5mg of prednisolone daily 8. Recent bisphosphonate prescription 1 year prior to fracture or consecutive 2 years within 5 years 9. Cognitive impairment assessed by TMSE less than 25 points
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcome 0, 3, 6 months Barthel index | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional outcome 0, 3, 6 months modified Harris Hip Score,Sarcopenia 0, 3, 6 months Hand grip strength,Sarcopenia 0, 3, 6 months Muscle mass by bioelectrical impedance analysis,Sarcopenia 0, 3, 6 months Time Up and Go test,Fracture healing 0, 3, 6 months Union of fracture,Fracture healing 0, 3, 6 months Radiographic Union Score for Hip,Fracture Healing 0, 3, 6 months Loss of reduction, Fixation failure | — |
Countries
Thailand
Contacts
Public ContactEkasame Vanitchareonkul
Siriraj Hospital, Mahidol University
Outcome results
None listed