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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-10-31

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.

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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.

Conditions

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Osteoporotic Fractures Femoral Neck Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early bisphosphonate use

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

Group Type ACTIVE_COMPARATOR

Risedronate

Intervention Type DRUG

Take risedronate 35 mg orally every week

Late bisphosphonate use

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Risedronate

Take risedronate 35 mg orally every week

Intervention Type DRUG

Other Intervention Names

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Actonel

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No