Research

Fragile Bone Registry

IRB Number: 27041

Institutional Review Board, Hospital for Special Surgery

May 24, 2007

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an 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, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Joseph M. Lane, MD

Co-Investigators

Dean G. Lorich, MD
Anas Saleh, MD
Jin Chen, BA (Research Coordinator)   

Summary

The purpose of the Fragile Bone Registry is to gather as much information as we can about patients as possible who have osteopenia, osteoporosis, or a history of a low energy fracture.  This will facilitate investigators in developing a better understanding of the clinical features, pathobiology, and genetic links associated with fragile bones. With this increased knowledge, investigators hope to identify the unmet needs of patients with fragile bones and develop new and better treatments to improve disease outcomes and quality of life. Patients will be asked to allow researchers to gather information about their background and medical history, and gather clinical information on them. Approximately 600 patients will be enrolled during the course of this registry. Patients will be followed-up on a yearly basis

Inclusion/Exclusion Criteria

Inclusion criteria:

  • Only adult patients (=18 years of age) will be included
  • Patients diagnosed with “fragile bones” will be requested to enroll in the registry. The determination of “fragile bone” will be made based on the patient’s DEXA score and/or fracture history
  • DEXA Z-score less than -1.0 in patients 35 years of age or under (defines patients with low bone density)
  • DEXA T-score less than -1.0 in patients over 35 years of age (defines patients with low bone density)
  • History of low energy fracture. Low energy fractures will be defined by a fracture sustained by a fall from standing height or less
  • A history of hip fracture at any age. Majority of hip fractures have been associated with underlying bone disease

Exclusion criteria:

  • Subjects with cognitive impairment or other factors that would seriously affect the individual’s ability to complete the questionnaire or provide consent will be excluded from the registry.

Contact Information

Joseph M.Lane, MD
212.606.1172
lanej@hss.edu

Jin Chen  (Research Coordinator)
212.606.1604
ChenJin@hss.edu



Request an Appointment