Overview

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

Status:
Unknown status
Trial end date:
2017-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mahidol University
Treatments:
Diphosphonates
Etidronic Acid
Risedronate Sodium
Risedronic Acid
Criteria
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