Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy
- Conditions
- Prodromal Bone DeteriorationOsteoporosisAtypical Femoral Fractures
- Registration Number
- NCT02155595
- Lead Sponsor
- Henry Ford Health System
- Brief Summary
The purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone) fractures after long term fracture prevention therapy with a class of drugs called "bisphosphonates", colloquially referred to as Alendronate, risedronate, Ibandronate, and Zoledronate.
In addition, the study is designed to find out which patient is most likely to develop this potential life changing complication and why. Finally, the results of this study will help clinicians to better understand the reason and thus tailor patient specific treatments...i.e., "the right treatment for the right patient for right duration."
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 738
- women with a diagnosis of osteopenia or osteoporosis as defined by Bone Mineral density (BMD)
- patient treated with BPs for >5 years
- patients treated with non-BP anti-fracture medications such as...
- estrogens, raloxifene, calcitonin
- treatment naive patients
- all men regardless of BMD result
- patients with obvious traumatic AFF
- patients with normal BMD (better than -1.0 T-score at spine or proximal hip)
- unable to take tetracycline
- previous use of teriparatide
- known allergies to the following:
- tetracycline antibiotics
- meperidine
- midazolam
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prodromal bone deterioration (PBD) 5 years Determine the prevalence of PBD and/or Atypical Femoral Fractures (AFF) in patients with post-menopausal or glucocorticoid related osteoporosis, either treated with bisphosphonate (BP) for more than 2 years or never treated with a BP
- Secondary Outcome Measures
Name Time Method Diagnosis of PBD 5 years Refine diagnostic criteria for the diagnosis of PBD
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (1)
Henry Ford Medical Center, New Center One
🇺🇸Detroit, Michigan, United States
Henry Ford Medical Center, New Center One🇺🇸Detroit, Michigan, United States