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Purpose

RESTORE tests whether Augmented-FLS, where patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health provider, is better than Enhanced Usual Care, which includes patient and PCP education and activation. We also aim to determine the influence of age, race, ethnicity, sex, poverty level, geographic region, and timing of entry into the trial after a fracture on the effectiveness of the two strategies.

Conditions

Eligibility

Eligible Ages
Over 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 50 years and older (no upper age limit) - Sustained a primary fragility fracture (hip/femur/pelvis, clinical spine, humerus, wrist/forearm) in the last 6 months - Participant must self-identify a regular primary care provider (PCP)

Exclusion Criteria

  • Exposure to the following medications in the prior 12 months - Actonel or Atelvia (risedronate) - Fosamax or Binosto (alendronate) - Reclast, Zometa, or Aclasta (zoledronic acid, zoledronate) - Boniva or Bondronat (ibandronate) - Aredia (pamidronate) - Prolia (denosumab) - Evenity (romozosumab) - Tymlos (abaloparatide) - Forteo (teriparatide) - Natpara (parathyroid hormone) - Evista (raloxifene) - Miacalcin (calcitonin) - Diagnosis of the following medical conditions - CKD stage 4 and above - Paget's disease - Multiple myeloma - Osteomalacia - Addison's disease - Adrenal insufficiency - Enrolled hospice care - Solid organ transplant - Bone marrow transplant - Fractures resulting from severe trauma - Scheduled appointment with a bone health clinician

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Enhanced Usual Care Arm 		Participants will be mailed education materials and encouraged to follow up with their primary care physician.
  • Behavioral: Enhanced Usual Care Arm
    Patients will be mailed education materials and encouraged to follow up with their primary care physician.
Experimental
Augmented-Fracture Liaison Service Arm 		Participants will be mailed education materials. Participants will also be contacted by patient navigators who will guide participants through the process of getting a Bone Health Clinician appointment.
  • Behavioral: Augmented-Fracture Liaison Service Arm
    Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Elizabeth M Dye, MSN
2059965025
emmills@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Elizabeth M Dye, MSN
2059965025
emmills@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.