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

Osteoporotic Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02148848
• Other study ID #: 229/2556(EC4)
• Status: Recruiting
• Phase: Phase 4
• First received: May 23, 2014
• Last updated: September 13, 2016
• Start date: June 2013
• Est. completion date: October 2017

Study information

• Verified date: September 2016
• Source: Mahidol University
• Contact: Aasis Unanantana, M.D.
• Phone: (66)24197968
• Email: uaasis[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone
• Osteoporotic Fractures

Intervention

Drug:
• Risedronate
Take risedronate 35 mg orally every week

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	de Morton Mobility Index		3 months after surgery
Secondary	Barthel index		3 months after surgery
Secondary	Visual analog scale score		3 months after surgery
Secondary	Two minutes walking test		3 months after surgery
Secondary	Timed get up and go test		3 months after surgery
Secondary	EuroQoL-5D (EQ-5D)		3 months after surgery