RESTORE: REducing Future FractureS and Improving OuTcOmes of FRagility FracturE

Description

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

Osteoporosis, Osteoporotic Fractures

Study Overview

Study Details

Study overview

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.

RESTORE: REducing Future FractureS and Improving OuTcOmes of FRagility FracturE

RESTORE: REducing Future FractureS and Improving OuTcOmes of FRagility FracturE

Condition
Osteoporosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Kenneth Saag, MD, MSc, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Maria Danila, MD, MSPH, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2029-06-01