Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

Completed

Conditions studied: Osteoporosis, Atypical Femoral Fractures, Prodromal Bone Deterioration

In brief

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."

Key facts

Study ID

NCT02155595

Run by

Henry Ford Health System

People needed

738

Starts

2014-05-01

Expected to finish

2018-08-31

Last updated by the study team

2019-03-29

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Henry Ford Medical Center, New Center One — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.