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

Mahidol University

Status and phase: Unknown; Phase 4

Conditions: Osteoporotic Fractures; Femoral Neck Fracture

Treatments: Drug: Risedronate

Study type: Interventional

Funder types: Other

Identifiers

NCT02148848

229/2556(EC4)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Early bisphosphonate use

Active Comparator group

Description:

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

Treatment:

Drug: Risedronate

Late bisphosphonate use

No Intervention group

Description:

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.