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

Primary Purpose

Osteoporotic Fractures, Femoral Neck Fracture

Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Risedronate
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporotic Fractures focused on measuring Osteoporosis, Femoral neck fracture, hemiarthroplasty

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Early bisphosphonate use

Late bisphosphonate use

Arm 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

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.

Outcomes

Primary Outcome Measures

de Morton Mobility Index

Secondary Outcome Measures

Barthel index
Visual analog scale score
Two minutes walking test
Timed get up and go test
EuroQoL-5D (EQ-5D)

Full Information

First Posted
May 23, 2014
Last Updated
September 13, 2016
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02148848
Brief Title
Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporotic Fractures, Femoral Neck Fracture
Keywords
Osteoporosis, Femoral neck fracture, hemiarthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early bisphosphonate use
Arm Type
Active Comparator
Arm 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
Arm Title
Late bisphosphonate use
Arm Type
No Intervention
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Risedronate
Other Intervention Name(s)
Actonel
Intervention Description
Take risedronate 35 mg orally every week
Primary Outcome Measure Information:
Title
de Morton Mobility Index
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Barthel index
Time Frame
3 months after surgery
Title
Visual analog scale score
Time Frame
3 months after surgery
Title
Two minutes walking test
Time Frame
3 months after surgery
Title
Timed get up and go test
Time Frame
3 months after surgery
Title
EuroQoL-5D (EQ-5D)
Time Frame
3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aasis Unanantana, M.D.
Phone
(66)24197968
Email
uaasis@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Panai Laohaprasitiporn, M.D.
Phone
(66)24197968
Email
p_you_n@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aasis Unnanuntana, MD
Organizational Affiliation
Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aasis Unnanantana, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
28283937
Citation
Unnanuntana A, Laohaprasitiporn P, Jarusriwanna A. Effect of bisphosphonate initiation at week 2 versus week 12 on short-term functional recovery after femoral neck fracture: a randomized controlled trial. Arch Osteoporos. 2017 Dec;12(1):27. doi: 10.1007/s11657-017-0321-8. Epub 2017 Mar 10.
Results Reference
derived

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

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