Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy (NIH fracture)
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Treatments
Details and patient eligibility
About
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."
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
738 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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