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Recruiting

NCT Number: NCT06455085

RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

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.

Recruiting

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 50 years and older (no upper age limit)
  • Sustained a primary fragility fracture (hip/femur, pelvis, clinical spine, humerus, wrist) in the last 12 months
  • Participant must self-identify a regular primary care provider (PCP)
  • Participant must provide a mailing address
  • Participant must plan to remain geographically proximate (able to travel if necessary) to the site from which they are recruited over the next several months

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)
  • Duavee (bazedoxifene-conjugated estrogen)
  • Miacalcin (calcitonin)
  • Diagnosis of the following medical conditions;
  • CKD stage 4 or 5 or on dialysis
  • Multiple myeloma
  • Addison's disease
  • Adrenal insufficiency
  • Enrolled hospice care
  • Solid organ transplant, or expecting a solid organ transplant
  • Bone marrow transplant
  • History of metabolic bone disease (except osteoporosis) such as Paget's disease, osteomalacia, osteogenesis imperfecta, or Cushing's disease
  • Fractures resulting from severe trauma (e.g. motor vehicle accidents, a fall from 2 feet or higher elevation)
  • Pathologic fractures secondary to malignancy or infection
  • Scheduled appointment with a bone health specialist
  • Participant unable to consent on their own (cognitive impairment, dementia, etc.)
  • Currently enrolled in another research study that requires taking medication

Treatment and study plan

Augmented-Fracture Liaison Service Arm

Behavioral

Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.

Enhanced Usual Care Arm

Behavioral

Patients will be mailed education materials and encouraged to follow up with their primary care physician.

Primary outcomes

  1. Incidence of subsequent fracture

    Time frame: 24 months post randomization

    Incidence of fracture 24 months post randomization

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth M Dye, MSN

CONTACT

[email protected]

205-996-5025

Paolo Rusconi, PhD

CONTACT

[email protected]

205-975-2405

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: RESTORE

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 12, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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