Femoral Neck Fracture, Osteoporotic Fractures
Conditions
Keywords
Osteoporosis, Femoral neck fracture, hemiarthroplasty
Brief summary
Femoral neck fracture in the elderly is one indication for initiating osteoporosis treatment. Bisphosphonates remain the first line therapy; however, many orthopaedic surgeons concern regarding their effects on fracture healing process. Therefore, therapy is usually delayed for a period of time. To the best of our knowledge, there is no scientific data to support whether bisphosphonate treatment should be given immediately after the surgery or it should be delayed.
Detailed description
Femoral neck fracture in the elderly is one indication for initiating osteoporosis treatment. Bisphosphonates remain the first line therapy; however, many orthopaedic surgeons concern regarding their effects on fracture healing process. Therefore, therapy is usually delayed for a period of time. To the best of our knowledge, there is no scientific data to support whether bisphosphonate treatment should be given immediately after the surgery or it should be delayed. This study aims to compare functional recovery between early- and late administration of bisphosphonate in patients who received hemiarthroplasty following femoral neck fractures.
Interventions
DRUGRisedronate
Take risedronate 35 mg orally every week
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient diagnosed with femoral neck fracture and was treated with bipolar hemiarthroplasty * Age more than 50 years old and bone mineral density (BMD) was in osteoporotic (T-score less than -2.5) or osteopenic (T-score between -1.0 and -2.5) ranges
Exclusion criteria
* Patients who were treated with bipolar hemiarthroplasty for more than 2 weeks * Patients with postoperative complications which affect the postoperative rehabilitation program e.g. intraoperative cracking or fracture, postoperative cardiac complication * Have contraindications for bisphosphonates use e.g. renal insufficiency (glomerular filtration rate (GFR) \< 30 ml/min), allergy to bisphosphonates, severe esophagitis, gastroesophageal reflux disease etc. * Patients with conditions/disorders which have an affect on bone mineral density or bone metabolism e.g. renal insufficiency, rheumatoid arthritis, Paget's disease, renal osteodystrophy, hyperparathyroidism, glucocorticoids use etc. * History of bisphosphonates use within 12 months * Open fracture, multiple fracture or multiple trauma patients * Pathological fracture * Bilateral lower extremity fractures * The pre-injury functional status of the patients is non-ambulatory
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| de Morton Mobility Index | 3 months after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Visual analog scale score | 3 months after surgery |
| Two minutes walking test | 3 months after surgery |
| Timed get up and go test | 3 months after surgery |
| EuroQoL-5D (EQ-5D) | 3 months after surgery |
| Barthel index | 3 months after surgery |
Countries
Thailand
Contacts
Primary ContactAasis Unanantana, M.D.
Backup ContactPanai Laohaprasitiporn, M.D.
Outcome results
None listed