Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

Completed

• Conditions: Prodromal Bone Deterioration; Osteoporosis; Atypical Femoral Fractures
• Interventions: Other: 500 without BP treatment; Other: 500 with BP treatment

• Registration Number: NCT02155595
• Lead Sponsor: Henry Ford Health System

Brief 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."

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-29
• Study Start: 2014-05
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-04
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-28
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 738

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
500 without BP treatment	500 without BP treatment	patients will undergo lab tests, X-ray, bone scan or MRI, as needed
500 with BP treatment	500 with BP treatment	patients will undergo lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy)

Primary Outcome Measures

Name	Time	Method
Prodromal bone deterioration (PBD)	5 years	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

Secondary Outcome Measures

Name	Time	Method
Diagnosis of PBD	5 years	Refine diagnostic criteria for the diagnosis of PBD

Trial Locations

Locations (1)

Henry Ford Medical Center, New Center One; 🇺🇸 Detroit, Michigan, United States