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Prevention of Periprosthetic Bone Loss After Total Hip Replacement by Annual Bisphosphonate Therapy

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ClinicalTrials.gov Identifier: NCT02838121
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : July 20, 2016
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Mel Shiuann-Sheng Lee, Chang Gung Memorial Hospital

Brief Summary:
Periprosthetic bone loss caused by stress-shielding effect, a phenomenon of bone atrophy under mechanical unloading after THR implantation, further compromises the longevity of implant. The prospective randomized study is aimed to investigate the periprosthetic bone loss after primary total hip replacements.

Condition or disease Intervention/treatment Phase
Prevention of BMD Loss After THR Serum Markers of Bone Turnover Functional Outcomes Drug: Aclasta Drug: Placebo Phase 3

Detailed Description:
This study is a prospective, randomized, open-label clinical trial. The study will be performed in patients after obtaining informed consent. Group assignment is by drawing a sealed envelops based on random table. (1) Group 1: Experimental group 30 cases, Aclasta® (Zoledronic acid 5mg/100ml) is given intravenously on the 4th postoperative day and one year after the total hip replacement, (2) Group 2: Control group, 30 cases, no bisphosphonate is given to the patients. Only the unilateral coxarthrosis will be recruited for the study. Patients will be analyzed with (1) DXA study (2) Clinical assessment (Harris hip score and SF-12) (3) X-ray (4) serum marker of bone turnover. Patients will be scheduled for specified examinations preoperatively, postoperatively 6 weeks, 3 months, 6 months, 12 months, and 24 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation on the Prevention of Periprosthetic Bone Loss After Total Hip Replacement by Annual Bisphosphonate Therapy: A Prospective Randomized Clinical Trial
Study Start Date : December 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Experimental: Aclasta
Aclasta IV once annual for 2 years
Drug: Aclasta
Aclasta once annually for 2 years

Placebo Comparator: Placebo
Placebo group
Drug: Placebo
No IV aclasta




Primary Outcome Measures :
  1. bone mineral density [g/cm2] of the 7 Gruen zones [ Time Frame: 5 years ]
    bone mineral density measured by dual energy x-ray absorptiometry

  2. bone mineral density change relative to the baseline values of the 7 Gruen zones [ Time Frame: 5 years ]
    bone mineral density measured by dual energy x-ray absorptiometry

  3. implant loosening or migration [ Time Frame: 5 years ]
    check the implant position by serial standard X ray follow-up


Secondary Outcome Measures :
  1. serum alkaline phosphatase [ Time Frame: 5 years ]
  2. serum calcium level [ Time Frame: 5 years ]
  3. serum phosphate level [ Time Frame: 5 years ]
  4. serum osteocalcin level [ Time Frame: 5 years ]
  5. serum N-telopeptide procollagen level [ Time Frame: 5 years ]
  6. serum creatinine level [ Time Frame: 5 years ]
    renal function and glomerular filtration rate

  7. serum alanine aminotransferase level [ Time Frame: 5 years ]
    liver function

  8. serum aspartate aminotransferase level [ Time Frame: 5 years ]
    liver function

  9. harris hip score [ Time Frame: 5 years ]
    hip function measurement

  10. short form-12 [ Time Frame: 5 years ]
    life quality measurement

  11. University of California Los Angeles Activity Score [ Time Frame: 5 years ]
    functional and activity evaluation, 10 point scale



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female,between 35 and 85 years of age
  2. Indicated for Total hip replacement for various hip diseases
  3. Has preoperative DXA study within 3 months before the total hip replacement procedure or willing to receive preoperative DXA study as a baseline comparison
  4. Signed written informed consent
  5. Standard transgluteal approach for total hip replacement using Zimmer Triology Cup and Versys Fiber Metal Taper Stem with metal to highly cross-linked polyethylene bearing surface

Exclusion Criteria:

  1. Any prior use of intravenous bisphosphonate within the last 2 years
  2. Uncontrolled seizure disorders associated with falls
  3. A history of invasive malignancy of any organ system, treated or untreated, within the past five years; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed
  4. Carcinoma in situ of the uterine cervix
  5. History of osteogenesis imperfecta, multiple myeloma, or Paget's disease
  6. Active primary hyperparathyroidism
  7. History of iritis or uveitis
  8. Self-reported history of diabetic nephropathy or retinopathy
  9. AST or ALT more than twice the upper limit of normal
  10. Alkaline phosphatase more than twice the upper limit of normal
  11. Serum calcium 2.75 mmol/L (11.0 mg/dL)
  12. Baseline renal insufficiency (calculated creatinine clearance 35 ml/min)
  13. History of hypersensitivity to bisphosphonates
  14. Use of any investigational drug(s) and/or devices within 30 days prior to randomization
  15. Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the participant from adhering to the Protocol or completing the trial per protocol
  16. Use of hip protectors
  17. With implant or prosthesis on the contralateral hip joint

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): NCT02838121


Locations
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Taiwan
Chang Gung Memorial Hospital
Kweishan, Taoyuan, Taiwan, 333
Sponsors and Collaborators
Mel Shiuann-Sheng Lee
Novartis

Additional Information:
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Responsible Party: Mel Shiuann-Sheng Lee, Clinical Professor, Chang Gung Memorial Hospital, Department of Orthopaedic Surgery, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02838121     History of Changes
Other Study ID Numbers: 98-1150A3
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mel Shiuann-Sheng Lee, Chang Gung Memorial Hospital:
bisphosphonate
Total hip replacement
functional outcomes
bone mineral density

Additional relevant MeSH terms:
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Diphosphonates
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs