Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy



Status:Completed
Conditions:Osteoporosis, Orthopedic, Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:50 - Any
Updated:3/31/2019
Start Date:May 2014
End Date:August 31, 2018

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Trial Summary
Trial Overview
Inclusion Criteria
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."


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
We found this trial at
1
site
Henry Ford Medical Center, New Center One
Detroit, Michigan 48202
Principal Investigator: Sudhaker D. Rao, M.B;B.S.
Phone: 313-971-4984
?
mi
from
Detroit, MI
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