Protocol Number: 01-D-0184

Title:

Evaluation and Treatment of Skeletal Diseases

Number:

01-D-0184

Summary:

This study has four objectives: 1) to provide investigators the opportunity to study bone specimens from patients with various skeletal diseases; 2) to treat patients with skeletal diseases at the NIH; 3) to expose NIH trainees to certain skeletal diseases; and 4) to gain more knowledge about skeletal diseases and stimulate further study of bone biology.

Anyone with a disease that affects the skeleton may be eligible for this study.

All evaluations, tests, procedures and treatments given study participants are used in the standard care of skeletal diseases. No experimental evaluations or treatments are offered. Patient evaluations include a medical history, review of medical records and routine physical examination. Based on the findings, other procedures may be recommended, including blood tests, urine tests, and imaging tests, such as X-rays, bone densitometry, bone scan, computed tomography (CT) and magnetic resonance imaging (MRI).

Bone specimens from participants will be collected for research use. Specimens will be obtained from bone removed during a patient's planned surgical procedure performed for medical care, or patients may be requested to have a bone biopsy-removal of a small piece of bone tissue-as part of the patient evaluation procedure.

Sponsoring Institute:

National Institute of Dental And Craniofacial Research (NIDCR)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Specimens to be shipped will be considered either "surgical waste" or the harvesting of the specimen will be approved by an IRB-approved protocol at the sending institution. The specimen will be sent with a copy of the signed consent.

Patients of any age, gender, or ethnicity with skeletal diseases who are not enrolled in other protocols which otherwise allow for the evaluation and treatment of these diseases.

Women of childbearing age or lactating will have pregnancy ruled-out with a serum pregnancy test and/or not undergo testing involving radiation or receive medications without demonstrated safety in pregnancy.

Patients must be referred from a practitioner who will continue their care/evaluation upon discharge, or in tandem with this protocol.

EXCLUSION CRITERIA:

Patients with significant cognitive impairment who are unable to give informed consent. Patients with achondroplasias are often mentally compromised.

Patients with serious, uncontrolled metabolic organ system dysfunction (decompensated heart failure, diabetes, etc.).

Special Instructions: Currently Not Provided

Keywords:

Bone

Dysplasia

Fragility

Osteomalacia

Recruitment Keywords:

Osteoporosis

Dysplasia

Osteomalacia

Bone Diseases

Skeletal Disease

Conditions:

Bone Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations: Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/16/2004