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Trial record 21 of 101 for:    Risedronate

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
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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.

Condition or disease Intervention/treatment Phase
Osteoporotic Fractures Femoral Neck Fracture Drug: Risedronate Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Drug: Risedronate
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.




Primary Outcome Measures :
  1. de Morton Mobility Index [ Time Frame: 3 months after surgery ]

Secondary Outcome Measures :
  1. Barthel index [ Time Frame: 3 months after surgery ]
  2. Visual analog scale score [ Time Frame: 3 months after surgery ]
  3. Two minutes walking test [ Time Frame: 3 months after surgery ]
  4. Timed get up and go test [ Time Frame: 3 months after surgery ]
  5. EuroQoL-5D (EQ-5D) [ Time Frame: 3 months after surgery ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Aasis Unanantana, M.D. (66)24197968 uaasis@gmail.com
Contact: Panai Laohaprasitiporn, M.D. (66)24197968 p_you_n@hotmail.com

Locations
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Thailand
Siriraj Hospital Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Principal Investigator: Aasis Unnanantana, M.D.         
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Aasis Unnanuntana, MD Siriraj Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02148848     History of Changes
Other Study ID Numbers: 229/2556(EC4)
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016

Keywords provided by Mahidol University:
Osteoporosis
Femoral neck fracture
hemiarthroplasty

Additional relevant MeSH terms:
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Risedronic Acid
Fractures, Bone
Femoral Neck Fractures
Osteoporotic Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries
Etidronic Acid
Diphosphonates
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents