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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06455085
Other study ID # IRB-300012444
Secondary ID OFP-2022C3-30386
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2024
Est. completion date June 1, 2029

Study information

Verified date June 2024
Source University of Alabama at Birmingham
Contact Brianna M Holder, MBA
Phone 2059345097
Email bholder@uabmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2634
Est. completion date June 1, 2029
Est. primary completion date June 1, 2029
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 - Hyperparathyroidism - History of hyperthyroidism (stable on antithyroid therapy is allowed) - History of hypothyroidism (stable on thyroid replacement therapy is allowed) - Addison's disease - Adrenal insufficiency - Enrolled hospice care - Solid organ transplant - Bone marrow transplant - Active malignancy undergoing treatment, hospice

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Augmented-Fracture Liaison Service Arm
Patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health clinician.
Enhanced Usual Care Arm
Patients will be mailed education materials and encouraged to follow up with their primary care physician.

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of subsequent fracture Incidence of fracture 24 months post randomization 24 months post randomization
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