Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT05845021

Conditions

Osteoporosis

Arthroplasty Complications

Fragility Fracture

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Surgeon-Initiated Bone Health Referral Pathway

Study Details

Brief summary:

The goal of this clinical trial is to observe the impact of a surgeon-driven bone health referral pathway following lower extremity arthroplasty. The main question this study aims to answer is:

1\) What is impact of a surgeon-driven bone health referral pathway on implant-related complications and fragility fractures when compared to standard of care primary care provider referral.

Researchers will compare the endocrinology referral pathway and standard of care to see if there is a difference in treatment rates, fragility fractures, and implant-related complications following lower extremity arthroplasty.

Conditions

Osteoporosis

Arthroplasty Complications

Fragility Fracture

Study ID

NCT05845021

Start date

Sep 27, 2023

Status verified date

Oct, 2025

Completion date

Jul, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • >50
  • DEXA-confirmed diagnosis of osteoporosis

Exclusion Criteria:

  • Prior diagnosis of osteoporosis
  • Prior treatment for osteoporosis

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Surgeon-Initiated Bone Health Referral Pathway

Patients assigned in the endocrinology bone health referral pathway would be formally referred by the surgeon to see endocrinology for clearance before undergoing lower extremity arthroplasty. In addition to normal labs, the surgeon will initiate additional bone health labs in these patients before consultation with endocrinology. Endocrinology providers will be available for a virtual consultation to review the patients DEXA and bone health labs; start the patient on the appropriate medication; and provide patient education regarding osteoporosis and bone health. For those undergoing evaluation by endocrinology, these providers will let the surgical team know when and whether the patient has initiated treatment.

no intervention: Standard of Care

The control arm will be composed of patients identified in the osteoporotic range like the endocrinology bone health referral pathway. These patients will be told by the surgeon that the patient has osteoporosis based on the DEXA scan and will be told to follow-up these results with the patient's primary care provider. These patients do not need bone health clearance before undergoing surgery. Only serum 25-hydroxyvitamin D levels will be added on to the patient's standard of care pre-operative labs. The control arm is the current standard of care. Comparing this pathway to the endocrinology referral pathway permits an assessment on the efficacy of the new pathway.

Interventions

Surgeon-Initiated Bone Health Referral Pathway

Described in arm description

Primary outcome measure

  • Incidence of All-Cause Revision following Lower Extremity Arthroplasty [ Time Frame: 2-years postoperatively ]
  • Incidence of Fragility Fracture following Lower Extremity Arthroplasty [ Time Frame: 2-years postoperatively ]

Central Contacts and Locations

Central contacts

Savyasachi C Thakkar, MD

443-997-2663sthakka2@jhmi.edu

Locations

Charter Professional Center

Recruiting

Columbia, Maryland, United States, 21044

More Information

Sponsor

Johns Hopkins University

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-10-14.