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Bone Health Referral for Joint Replacement Surgery

N/A

Recruiting

Led By Savyasachi Thakkar, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

>50 DEXA-confirmed diagnosis of osteoporosis

Be older than 18 years old

Must not have

Prior treatment for osteoporosis

Prior diagnosis of osteoporosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-years postoperatively

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two care pathways and observe if one leads to fewer implant-related complications & fragility fractures after lower extremity joint replacement surgery.

Who is the study for?

This trial is for individuals over 50 who have been diagnosed with osteoporosis through a DEXA scan and are undergoing lower extremity arthroplasty. It's not open to those who have already been diagnosed or treated for osteoporosis before.

What is being tested?

The study is testing if a bone health referral pathway initiated by surgeons can reduce complications and fragility fractures after joint replacement surgery, compared to the usual referrals made by primary care providers.

What are the potential side effects?

Since this trial involves a referral process rather than direct medical interventions, there are no direct side effects from medications or treatments being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with osteoporosis through a DEXA scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been treated for osteoporosis before.

Select...

I have been diagnosed with osteoporosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-years postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-years postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-years postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of All-Cause Revision following Lower Extremity Arthroplasty

Incidence of Fragility Fracture following Lower Extremity Arthroplasty

Secondary study objectives

Incidence of Aseptic Loosening following Lower Extremity Arthroplasty

Incidence of Periprosthetic Fracture following Lower Extremity Arthroplasty

Incidence of Periprosthetic Joint Infection following Lower Extremity Arthroplasty

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Surgeon-Initiated Bone Health Referral PathwayExperimental Treatment1 Intervention

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.

Group II: Standard of CareActive Control1 Intervention

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.

0 / 3Eligibility criteria met