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Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

NCT02155595 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 738

Last updated 2019-03-29

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Sudhaker D. Rao, M.B;B.S. · Henry Ford Health System

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02155595 on ClinicalTrials.gov