Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

Henry Ford Health System738 enrolled

Overview

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."

Study Type

OBSERVATIONAL

Enrollment

738

Conditions

Osteoporosis Atypical Femoral Fractures Prodromal Bone Deterioration

Interventions

500 without BP treatment

Eligibility

Sex: FEMALEMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Prodromal bone deterioration (PBD)

Determine the prevalence of PBD and/or Atypical Femoral Fractures (AFF) in patients with post-menopausal or glucocorticoid related osteoporosis, either treated with bisphosphonate (BP) for more than 2 years or never treated with a BP

Time frame: 5 years

Secondary Outcomes

Diagnosis of PBD

Refine diagnostic criteria for the diagnosis of PBD