Lower Limb Geometry in Individuals with Atypical Femoral Fractures

June 13, 2014

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.

For further information, see Understanding Clinical Trials/Research Studies.

Principal Investigator

Joseph M. Lane, MD

Co-Investigators

Marjolein van der Meulen, PhD
Jeri  W. Nieves, PhD
Felicia Cosman, MD
Alana Serota, MD, CCFP, CCD
Dean G. Lorich, MD
David L. Helfet, MD
Douglas N. Mintz, MD
Shari Jawetz
Jonathan Kazam
Roger Bartolotta
Michael Loftus
Libi Galmer
Melvin Rosenwasser
William Macaulay
Jeffrey Geller
Elizabeth Shane
Emily Stein
Abigail Campbell
Ayelet Evrony
Jonathan Jo

Summary

This is a study enrolling 100 patients on long-term bisphosphonate treatment. The whole bone geometry as well as cortical structure along the length of the diaphysis will be analyzed through plain radiographs and CT imaging. Femoral structure of individuals who have experienced atypical femur fracture will be compared to patients of similar demographic and osteoporosis management who have not experienced such fractures. Any differences in femoral geometry between groups in this study will be significant as there are currently no predictors available for likelihood of AFF. This study aims to elucidate the pathophysiology of atypical femur fractures and identify risk factors based on structural geometry of the femur. This may allow inference of an appropriate duration of treatment of bisphosphonates, minimizing likelihood of these debilitating fractures, as well as identification of "susceptible" patients early on and alter decision to start, change, or discontinue BP therapy.

Inclusion/Exclusion Criteria

Inclusion Criteria:   Group 1: AFF patients

•  Postmenopausal women (amenorrheic for >12 months)
•  BP treatment 5 or more years
•  Have been diagnosed with AFF in past 2 years as defined by all six ASBMR criteria [5):
  (7) location along the femur distal to the lesser trochanter and proximal to the supercondylar flare,
  (8) minimal or no trauma at fracture,
  (9) transverse or short oblique fracture configuration,
  (10) lack of or minimal comminution,
  (11) complete fractures that extend through both cortices and may be associated with a medial "spike" - or, incomplete fractures that involve only the lateral cortex, and (12) periosteal and/or endosteal lateral stress reaction at the fracture site.

Group 2: Nonfractured patients

• Postmenopausal women
• BP treatment 5 or more years
• Asymptomatic regarding thigh, hip, groin pain (negative screen for prodromal symptoms)
  Have not ever experienced femoral or pelvic fracture

Group 3: IT and FN fracture patients

• Postmenopausal women
• BP treatment 5 or more years
• Have never been diagnosed with an atypical femur fracture by above criteria
• Have been diagnosed with an intertrochanteric or femoral neck fracture in past 2 years

These groups have limitations in that we will only include AFFs in BP-treated individuals, and our focus is on females only. The low incidence of these fractures in the general population requires focusing on AFF and setting the inclusion window at 2 years. Second, women are at greater risk of AFF so we will not study AFFs in men.

Exclusion Criteria:

• Patients with prior use of strontium ranelate or denosumab
•  Patients with AFF due to high energy trauma (fall from greater than standing height, motor vehicle trauma)
• Patients with bilateral femur fractures
• Patients with comorbid conditions that may alter bone morphology: bone tumor, metastatic cancer, or history of osteomyelitis in the femur

Note: Use of teriparatide (Forteo) will be recorded for dates used and duration.

 

Contact Information

Abigail Campbell
campbellab@hss.edu
Ayelet Evrony
evronya@hss.edu
212.606.1172