RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

Osteoporosis Clinical Trial

— RESTORE  

Official title:

RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

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
• 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
• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Osteoporotic Fractures

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