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

NCT02838121 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2016-07-20

No results posted yet for this study

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

Interventions

DRUG

Aclasta

Aclasta once annually for 2 years

DRUG

Placebo

No IV aclasta

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Mel Shiuann-Sheng Lee

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-01-31
Completion
2016-06-30

Countries

  • Taiwan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02838121 on ClinicalTrials.gov