Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy (NIH fracture)

March 28, 2019 updated by: Sudhaker D Rao, MD, Henry Ford Health System

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

738

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Medical Center, New Center One

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients will be found within the Henry Ford Health System Division of Endocrinology, Diabetes, Bone & Mineral Disorders

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / 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)
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)
500 without BP treatment
patients will undergo lab tests, X-ray, bone scan or MRI, as needed
Other: 500 without BP treatment
lab tests, X-ray, bone scan or MRI, as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prodromal bone deterioration (PBD)
Time Frame: 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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of PBD
Time Frame: 5 years
Refine diagnostic criteria for the diagnosis of PBD
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osteocyte lacunae
Time Frame: 5 years
Determine the prevalence of osteocyte lacunae. In BP treated patients with Severely Suppressed Bone Turnover (SSBT), PBD, or AFF, or with none of these complications, determine the prevalence of osteocyte lacunae in osteonal and interstitial iliac cortical bone
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Collaborators

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

Investigators

  • Principal Investigator: Sudhaker D. Rao, M.B;B.S., Henry Ford Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

June 2, 2014

First Posted (Estimate)

June 4, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 28, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01AR062103-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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