REducing future fractureS and improving ouTcOmes of fRagility fracturE
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StatusAccepting Candidates
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Age50 Years - 100 Years
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SexesAll
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Healthy Volunteers
Description
The purpose of the Fracture Prevention Program is to evaluate methods for
caring for patients after a recent bone break or fracture. Participants with a recent bone break, who have a regular doctor, and who do not have certain medical
conditions (cancer, severe kidney disease, or other bone diseases) and who don’t take certain medications will be asked to be part of the research study.
This is Fracture Prevention Program for up to 24 months (2 years).
Participants will be contacted via telephone to complete a baseline survey. After
completing the baseline survey, you will be contacted 12 and 24 months later to
complete another survey. Each survey will take 15-20 minutes to complete.
Details
| Protocol number | RESTORE |
Eligibility
Inclusion:
• 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
o Hip/femur includes femoral head, trochanter, femoral neck, proximal femur (excludes distal femur, middle femur, femoral shaft, supracondylar fracture, “closer to the knee”)
o Pelvis includes ischium, ilium, acetabulum, sacrum (excludes coccyx, tailbone)
o Clinical spine includes thoracic or lumbar vertebrae compression fractures or burst fractures (excludes cervical spine, coccyx)
o Humerus includes proximal humerus, upper arm (excludes distal humerus, middle humerus, humeral shaft, collar bone, elbow)
o Wrist includes distal radius, distal ulna, radial styloid, ulnar styloid, colles fracture (excludes proximal ulna, proximal radius, scaphoid, hand, carpals, boxer fracture, elbow)
• Participant must self-identify a regular primary care provider (PCP)
• Participant must provide a mailing address
Exclusion:
• 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)
- Conbriza or Viviant (bazedoxifene)
- 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
Lead researcher
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Porter F Young, MDOrthopaedic Surgeon
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
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Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.