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

NCT02838121 | Completed Phase 3

• 1 other identifier: 98-1150A3
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

bisphosphonate; Total hip replacement; functional outcomes; bone mineral density

Outcome Measures

Primary Outcomes (3)

• bone mineral density [g/cm2] of the 7 Gruen zones

  bone mineral density measured by dual energy x-ray absorptiometry

  5 years

• 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

• implant loosening or migration

  check the implant position by serial standard X ray follow-up

  5 years

Secondary Outcomes (11)

• serum alkaline phosphatase

  5 years

• serum calcium level

  5 years

• serum phosphate level

  5 years

• serum osteocalcin level

  5 years

• serum N-telopeptide procollagen level

  5 years

Study Arms (2)

Aclasta

EXPERIMENTAL

Aclasta IV once annual for 2 years

Drug: Aclasta

Placebo

PLACEBO COMPARATOR

Placebo group

Drug: Placebo

Interventions

Aclasta DRUG

Aclasta once annually for 2 years

Aclasta

Placebo DRUG

No IV aclasta

Placebo

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female,between 35 and 85 years of age
• Indicated for Total hip replacement for various hip diseases
• Has preoperative DXA study within 3 months before the total hip replacement procedure or willing to receive preoperative DXA study as a baseline comparison
• Signed written informed consent
• 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

You may not qualify if:

• Any prior use of intravenous bisphosphonate within the last 2 years
• Uncontrolled seizure disorders associated with falls
• 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
• Carcinoma in situ of the uterine cervix
• History of osteogenesis imperfecta, multiple myeloma, or Paget's disease
• Active primary hyperparathyroidism
• History of iritis or uveitis
• Self-reported history of diabetic nephropathy or retinopathy
• AST or ALT more than twice the upper limit of normal
• Alkaline phosphatase more than twice the upper limit of normal
• Serum calcium 2.75 mmol/L (11.0 mg/dL)
• Baseline renal insufficiency (calculated creatinine clearance 35 ml/min)
• History of hypersensitivity to bisphosphonates
• Use of any investigational drug(s) and/or devices within 30 days prior to randomization
• 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

Sponsors & Collaborators

• Mel Shiuann-Sheng Lee: lead
• Novartis: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Kweishan, Taoyuan, 333, Taiwan

Location

Related Links

• Chang Gung Memorial Hospital
• American Academy of Orthopaedic Surgeons

MeSH Terms

Interventions

Zoledronic Acid

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor, Chang Gung Memorial Hospital, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 20, 2016
• Study Start: December 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2016
• Last Updated: July 20, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)