RECRUITING

RESTORE: REducing Future FractureS and Improving OuTcOmes of FRagility FracturE

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

RESTORE: REducing Future FractureS and Improving OuTcOmes of FRagility FracturE

Quick Facts

Study Start:2024-12-16
Study Completion:2029-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06455085

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.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 50 years and older (no upper age limit)
  2. * Sustained a primary fragility fracture (hip/femur/pelvis, clinical spine, humerus, wrist/forearm) in the last 6 months
  3. * Participant must self-identify a regular primary care provider (PCP)
  1. * Exposure to the following medications in the prior 12 months
  2. * Actonel or Atelvia (risedronate)
  3. * Fosamax or Binosto (alendronate)
  4. * Reclast, Zometa, or Aclasta (zoledronic acid, zoledronate)
  5. * Boniva or Bondronat (ibandronate)
  6. * Aredia (pamidronate)
  7. * Prolia (denosumab)
  8. * Evenity (romozosumab)
  9. * Tymlos (abaloparatide)
  10. * Forteo (teriparatide)
  11. * Natpara (parathyroid hormone)
  12. * Evista (raloxifene)
  13. * Miacalcin (calcitonin)
  14. * Diagnosis of the following medical conditions
  15. * CKD stage 4 and above
  16. * Paget's disease
  17. * Multiple myeloma
  18. * Osteomalacia
  19. * Addison's disease
  20. * Adrenal insufficiency
  21. * Enrolled hospice care
  22. * Solid organ transplant
  23. * Bone marrow transplant
  24. * Fractures resulting from severe trauma
  25. * Scheduled appointment with a bone health clinician

Contacts and Locations

Study Contact

Elizabeth M Dye, MSN
CONTACT
2059965025
emmills@uabmc.edu
Kate Bryan
CONTACT
205-934-0377
kbryan@uabmc.edu

Principal Investigator

Kenneth Saag, MD, MSc
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Maria Danila, MD, MSPH
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-16
Study Completion Date2029-06-01

Study Record Updates

Study Start Date2024-12-16
Study Completion Date2029-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Osteoporosis
  • Osteoporotic Fractures