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

Functional Outcomes Clinical Trial

Official title:

Investigation on the Prevention of Periprosthetic Bone Loss After Total Hip Replacement by Annual Bisphosphonate Therapy: A Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838121
• Other study ID #: 98-1150A3
• Status: Completed
• Phase: Phase 3
• First received: July 7, 2016
• Last updated: July 15, 2016
• Start date: December 2009
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2016
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Functional Outcomes
• Prevention of BMD Loss After THR
• Serum Markers of Bone Turnover

Intervention

Drug:
• Aclasta
Aclasta once annually for 2 years
• Placebo
No IV aclasta

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kweishan	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Mel Shiuann-Sheng Lee	Novartis

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mineral density [g/cm2] of the 7 Gruen zones	bone mineral density measured by dual energy x-ray absorptiometry	5 years	No
Primary	bone mineral density change relative to the baseline values of the 7 Gruen zones	bone mineral density measured by dual energy x-ray absorptiometry	5 years	No
Primary	implant loosening or migration	check the implant position by serial standard X ray follow-up	5 years	No
Secondary	serum alkaline phosphatase		5 years	No
Secondary	serum calcium level		5 years	No
Secondary	serum phosphate level		5 years	No
Secondary	serum osteocalcin level		5 years	No
Secondary	serum N-telopeptide procollagen level		5 years	No
Secondary	serum creatinine level	renal function and glomerular filtration rate	5 years	No
Secondary	serum alanine aminotransferase level	liver function	5 years	No
Secondary	serum aspartate aminotransferase level	liver function	5 years	No
Secondary	harris hip score	hip function measurement	5 years	No
Secondary	short form-12	life quality measurement	5 years	No
Secondary	University of California Los Angeles Activity Score	functional and activity evaluation, 10 point scale	5 years	No

External Links

•   American Academy of Orthopaedic Surgeons