Improving outcomes for patients with fragility fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

RESTORE evaluates the effectiveness of an Augmented Fracture Liaison Service, where patients receive support from a navigator and are referred to bone health providers, compared to Enhanced Usual Care that focuses on education for patients and primary care providers. The study aims to assess how factors such as age, race, ethnicity, sex, poverty level, geographic region, and timing of entry after a fracture influence the success of these two approaches. Participants must be 50 years or older and have experienced a primary fragility fracture within the last six months.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic Arizona
  Scottsdale, Arizona, United States Recruiting
• UAMS Health
  North Little Rock, Arkansas, United States Recruiting
• University of Florida- Gainesville
  Gainesville, Florida, United States Recruiting
• University of Florida- Jacksonville
  Jacksonville, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Kenneth Saag, MD, MSc — University of Alabama at Birmingham
• Study coordinator: Elizabeth M Dye, MSN
• Email: emmills@uabmc.edu
• Phone: 205-996-5025

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using an osteoporotic fracture score to guide treatment for thoracic and lumbar spine fractures

  This study will try using the OF (osteoporotic fracture) score to help doctors decide between surgery and non-surgical care for older adults with painful thoracic or lumbar osteoporotic fractures.

  Recruiting at 3 sites AO Foundation, AO Spine · San Francisco, California and 14 other locations · NCT07027306

• Surgeon-driven bone health referral for patients having lower limb joint replacement

  This study is testing if sending patients with osteoporosis to a bone health specialist before getting lower limb joint replacement surgery can help reduce fractures and complications compared to regular care.

  Recruiting Johns Hopkins University · Columbia, Maryland · NCT05845021

• Preventing secondary hip fractures in postmenopausal women

  This study is testing if a new treatment can help prevent additional hip fractures in postmenopausal women who have already broken a hip and are having surgery to fix it.

  Recruiting at 48 sites AgNovos Healthcare, LLC · Innsbruck and 65 other locations · NCT04796350

• Analyzing bone damage in patients with osteoporosis and fragility fractures

  This study is testing how tiny changes in bones affect fracture risk in people with osteoporosis and fragility fractures who are having hip replacement surgery.

  Recruiting Politecnico di Milano · Miano, Milano · NCT04787679

• Role of LH and hCG in adults being evaluated for endocrine disorders

  This study looks at whether levels of luteinizing hormone (LH) and hCG in adults undergoing endocrine evaluation relate to their disease presence and outcomes.

  Recruiting Copenhagen University Hospital at Herlev · Herlev · NCT07824102

• Can a blood marker called lumican reveal hidden fragility in postmenopausal osteoporosis

  This study tests whether serum lumican levels can help identify hidden fragility risk in postmenopausal women beyond what bone density shows.

  Recruiting Kanuni Sultan Suleyman Training and Research Hospital · Küçükçekmece, Istanbul · NCT07677072

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.