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.

Condition	Treatment or Intervention
Bone Disease	Drug: Standard of care treatment

Human diseases are commonly manifested in the skeletal system. The skeleton may be the primary or secondary target of the disease and the disease may be congenital or acquired. While understanding of the molecular and cellular biology of the bone has blossomed in the last several years, much remains to be understood about the underlying biology of the skeleton. The gaps in the understanding of skeletal biology are evident in the paucity of tissue-specific therapies for skeletal diseases.

The objectives of this protocol are fourfold: 1) to allow us to receive bone specimens from investigators outside the NIH, 2) to provide a protocol within which patients with skeletal disease can be evaluated and treated here at NIH, 3) to provide a protocol under which trainees can evaluate patients with skeletal diseases and 4) to provide a pool of patients with skeletal diseases from which questions of basic pathogenetic mechanisms may serve as the basis for future studies.

Within this study, bone formation will be assessed using cell and molecular biological approaches when specimens are sent from outside of NIH, and when recruited to NIH, patients will undergo clinically-indicated testing and possibly receive treatment which will be limited to approved medications.

Genders Eligible for Study:  Both

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.).

Maryland
      National Institute of Dental And Craniofacial Research (NIDCR), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  010184; 01-D-0184
Record last reviewed:  August 3, 2003
Last Updated:  August 3, 2003
Record first received:  September 28, 2001
ClinicalTrials.gov Identifier:  NCT00024804
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08