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Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

Information source: Henry Ford Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis; Atypical Femoral Fractures; Prodromal Bone Deterioration

Intervention: 500 without BP treatment (Other); 500 with BP treatment (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: Henry Ford Health System

Official(s) and/or principal investigator(s):
Sudhaker D. Rao, M.B;B.S., Principal Investigator, Affiliation: Henry Ford Health System

Overall contact:
Sudhaker D. Rao, M.B;B.S., Phone: 313-971-4984, Email: srao1@hfhs.org

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."

Clinical Details

Official title: Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Prodromal bone deterioration (PBD)

Secondary outcome: Diagnosis of PBD

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

Sudhaker D. Rao, M.B;B.S., Phone: 313-971-4984, Email: srao1@hfhs.org

Henry Ford Medical Center, New Center One, Detroit, Michigan 48202, United States; Recruiting
Sudhaker D. Rao, M.B;B.S., Phone: 313-971-4984, Email: srao1@hfhs.org
Sudhaker D. Rao, M.B;B.S., Principal Investigator
Additional Information

Starting date: May 2014
Last updated: March 17, 2015

Page last updated: August 23, 2015

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