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New treatment option for Osteoporosis
Official title RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE
ClinicalTrials.gov ID: NCT06455085
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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...
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- North Little Rock, Arkansas, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Maywood, Illinois, United States
- Iowa City, Iowa, United States
- Coon Rapids, Minnesota, United States
- Columbia, Missouri, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Lebanon, New Hampshire, United States
- New York, New York, United States
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Columbus, Ohio, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Scottsdale, Arizona, United States; North Little Rock, Arkansas, United States; Gainesville, Florida, United States; Jacksonville, Florida, United States; Atlanta, Georgia, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.