Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparative Study of Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty in Patients With Osteoporotic Femoral Neck Fractures

Conditions
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Osteoporotic Fractures, Femoral Neck Fracture

Intervention / Treatment
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* Drug: Risedronate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early bisphosphonate use<br>Give risedronate (actonel) at 2 weeks after hemiarthroplasty for an osteoporotic femoral neck fracture. In addition, calcium and vitamin D supplementation will be given to all patients. Risedronate (35 mg) 1 tablet orally once a week | Drug: Risedronate<br>* Take risedronate 35 mg orally every week<br>* Other names: Actonel;|
| No Intervention: Late bisphosphonate use<br>Give only calcium and vitamin D supplementation during the first 3 months after the surgery. Bisphosphonate, risedronate (Actonel), will be given at 3 months after surgery for an osteoporotic femoral neck fracture. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| de Morton Mobility Index |  | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel index |  | 3 months after surgery | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Femoral neck fracture, hemiarthroplasty