Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty
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|ClinicalTrials.gov Identifier: NCT02148848|
Recruitment Status : Unknown
Verified September 2016 by Mahidol University.
Recruitment status was: Recruiting
First Posted : May 28, 2014
Last Update Posted : September 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Osteoporotic Fractures Femoral Neck Fracture||Drug: Risedronate||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||June 2013|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||October 2017|
Active Comparator: 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
Take risedronate 35 mg orally every week
Other Name: Actonel
No Intervention: 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.
- de Morton Mobility Index [ Time Frame: 3 months after surgery ]
- Barthel index [ Time Frame: 3 months after surgery ]
- Visual analog scale score [ Time Frame: 3 months after surgery ]
- Two minutes walking test [ Time Frame: 3 months after surgery ]
- Timed get up and go test [ Time Frame: 3 months after surgery ]
- EuroQoL-5D (EQ-5D) [ Time Frame: 3 months after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148848
|Contact: Aasis Unanantana, M.D.||(66)email@example.com|
|Contact: Panai Laohaprasitiporn, M.D.||(66)firstname.lastname@example.org|
|Bangkoknoi, Bangkok, Thailand, 10700|
|Principal Investigator: Aasis Unnanantana, M.D.|
|Principal Investigator:||Aasis Unnanuntana, MD||Siriraj Hospital|