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

Phase 4

• Conditions: Femoral Neck Fracture; Osteoporotic Fractures
• Interventions: Drug: Risedronate

• Registration Number: NCT02148848
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-05-23
• Study First Submitted QC: 2014-05-23
• Study First Posted: 2014-05-28
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-14
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early bisphosphonate use	Risedronate	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

Primary Outcome Measures

Name	Time	Method
de Morton Mobility Index	3 months after surgery

Secondary Outcome Measures

Name	Time	Method
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
Barthel index	3 months after surgery
EuroQoL-5D (EQ-5D)	3 months after surgery

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand