In a cohort of patients screened to have osteoporosis via preoperative dual-energy x-ray
absorptiometry (DEXA), the research study coordinator would randomly select patients to
undergo the endocrinology bone health referral pathway (treatment arm) or the standard of
care pathway (control) and notify the surgeon.
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 (See Lab Section) 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.
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 the
patient is 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.
Randomization to the respective treatment arms will be independent of the patient's
osteoporosis screening, laboratory results, or any other patient factors. Patients will
not have any other research study visits with endocrinology following the initial visit.
Patients will follow the normal post-operative visits with the surgeon. The surgeon will
state any postoperative implant related findings in the patient's postoperative notes and
the research team will accumulate these findings for each patient. Following lower
extremity arthroplasty, there will be no study specific visits. To observe the efficacy
of these endocrinology treatment pathway, this will be conducted following
intention-to-treat. If patients randomized to the endocrinology cohort do not want to see
endocrinology or see endocrinology but do not want to start treatment, the patient will
still be included in the endocrinology pathway cohort.
The study will be at least 5-years long to have enough patients to enroll and follow
post-op up to 2-years. Treatment of osteoporosis is independent of this study. If the
study were to end prematurely, patients are to continue taking the assigned medication if
the patient is taking a medication based on endocrinology's recommendation.
