Bisphosphonates Use After Total Joint Arthroplasty

Postoperative Use of Bisphosphonates Reduces Adverse Outcome After Primary Total Joint Arthroplasty: A Nationwide Population-based Cohort Study

Background Bisphosphonates has been associated with a decreased risk of revision total joint replacements because of its effects on decreased periprosthetic bone loss and prosthetic migration. However, the results in the early literature are inconsistent and the influence of bisphosphonates on associated complications and subsequent total joint arthroplasty (TJA) remains unknown. This study is to investigate the association between the use of bisphosphonates and risk of adverse outcomes after primary TJA.

Materials and Methods This matched cohort study utilized National Health Insurance Research Database in Taiwan to identify patients who underwent primary TJA over a 15-year period (January 2000- December 2015 inclusive). Study participants were further categorized into two groups: bisphosphonates users and nonusers, using propensity score matching. The Kaplan-Meier curve analysis and adjusted hazard ratios (aHR) of revision surgery, adverse outcomes of primary surgery and undergoing subsequent TJA were calculated using Cox regression analysis.

Study Overview

• Status: Completed
• Conditions: Diphosphonates
• Intervention / Treatment: Drug: Bisphosphonates, Combinations

• Study Type: Observational
• Enrollment (Actual): 27405

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11472
    • Tri-Service General Hospital, National Defense Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) was used to identify diagnoses and related procedures. The target cohort in NHIRD were those who underwent primary total joint arthroplasty during the study period (January 1, 2000 to December 31, 2015).

Description

Inclusion Criteria:

1. Patients who underwent primary total joint arthroplasty during the study period (January 1, 2000 to December 31, 2015).

Exclusion Criteria:

1. Patients with total joint arthroplasty before the index date,
2. Patients with existing pathologic fracture, nonunion of fracture and partial joint replacement,
3. Patients who were lost to follow-up
4. Patients < 40 years old

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
bisphosphonates users; Patients who underwent primary total joint arthroplasty with bisphosphonates use	Drug: Bisphosphonates, Combinations
bisphosphonates nonusers; Patients who underwent primary total joint arthroplasty without bisphosphonates use	Drug: Bisphosphonates, Combinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
revision rate of joint arthroplasty	revision rate of joint arthroplasty after primary surgery	a 15-year period (January 2000- December 2015 inclusive)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of secondary total joint arthroplasty	The rate of secondary total joint arthroplasty	a 15-year period (January 2000- December 2015 inclusive)
The rate of periprosthetic joint infection	The rate of periprosthetic joint infection	a 15-year period (January 2000- December 2015 inclusive)
The rate of periprosthetic fracture	The rate of periprosthetic fracture	a 15-year period (January 2000- December 2015 inclusive)
Mortality rate	Mortality rate	a 15-year period (January 2000- December 2015 inclusive)

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2000
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): November 2, 2022

Study Registration Dates

• First Submitted: November 13, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 20, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Bisphosphonates; Periprosthetic fracture; Total joint arthroplasty; Revision surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Diphosphonates
• Other Study ID Numbers: TSGH-D-110103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plans to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No