NCT02155595

Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 738 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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."

Conditions

• Osteoporosis
• Atypical Femoral Fractures
• Prodromal Bone Deterioration

Interventions

Type	Name	Description
OTHER	500 without BP treatment	lab tests, X-ray, bone scan or MRI, as needed
OTHER	500 with BP treatment	lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy)

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-08-31
• Completion: 2018-08-31
• First posted: 2014-06-04
• Last updated: 2019-03-29

Locations

1 site across 1 country: United States