Hip fractures Injury, Occupational Diseases, Poisoning Hip fracture
Conditions
Interventions
Intervention: tereparatide (Forsteo®) 20 µg/day injections
Comparator: standard care
Total duration of treatment: 6 weeks
Total duration of follow up: 6 months
Subjects participating in nested quali
Sponsors
North Bristol NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients admitted to Frenchay Hospital with diagnosis of a pertrochanteric femoral fracture over the age of 60 years (either sex)
Exclusion criteria
Exclusion criteria: Patients with any of the following would be excluded from the trial: 1. Fracture not as a result of a low energy injury/fall for example fall from standing height 2. Patients whose fracture is managed conservatively 3. Surgical fixation with total hip replacement (THR), hemiarthoplasty or cannulated screws 4. Previous treatment with PTH or other PTH analogues. 5. Hypersensitivity to the active substance or to any of the excipients. 6. Previous IV bisphosphonate (e.g. Zoledronic acid) in the previous 12 months 7. Strontium therapy for osteoporosis within the previous12 months 8. Current medications for breast and prostate cancer (e.g. tamoxifen, anastrozole, zoladex, prostap) or other hormone therapies such as testosterone, HRT 9. Decreased capacity to understand the risks of participating in the trial, 10. Metabolic bone disease e.g. Pagets disease & hyperparathyroidism other than primary osteoporosis or glucorticoid-induced osteoporosis. 11. Pre-existing hypercalcaemia or high or low corrected calcium which requires investigation. 12. Severe renal failure (EGFR 7 days post surgery 22. Current participation in any other clinical trial of medicinal product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant numbers including recruitment rate, drop out rate, mortality rates, measured at baseline, 6 weeks, 3 months, 6 months (+12 months for qualitative sub group) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Short Physical Performance Battery, measured at 6 weeks, 3 months (+6 months and 12 months for qualitative sub study) 2. 36-item Short Form Health Survey (SF36), measured at 6 weeks, 3 months, 6 months by phone (+ 12 months for qualitative sub study) 3. EQ5D, measured at 6 weeks, 3 months, 6 months by phone (+ 12 months for qualitative sub study) 4. Visual Analog Scale (VAS) pain, measured at 6 weeks, 3 months, 6 months by phone (+ 12 months for qualitative sub study) 5. Compliance rates, measured at 6 weeks | — |
Countries
United Kingdom
Outcome results
None listed