Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

738 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-08-31

Brief Summary

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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."

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Detailed Description

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Conditions

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Osteoporosis Atypical Femoral Fractures Prodromal Bone Deterioration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

500 with BP treatment

Intervention Type OTHER

lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy)

500 without BP treatment

patients will undergo lab tests, X-ray, bone scan or MRI, as needed

500 without BP treatment

Intervention Type OTHER

lab tests, X-ray, bone scan or MRI, as needed

Interventions

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500 without BP treatment

lab tests, X-ray, bone scan or MRI, as needed

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No