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| Sponsored by: |
National Institute of Dental and Craniofacial Research (NIDCR) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00024804 |
Purpose
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 |
|---|
|
Bone Disease |
| Study Type: | Observational |
| Official Title: | Evaluation and Treatment of Bone and Mineral Disorders |
| Study Start Date: | September 2001 |
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 and mineral disorders 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 tissue specimens from investigators outside and inside the NIH, 2) to provide a protocol within which patients with disorders of bone and mineral metabolism can be evaluated and treated, 3) to provide a protocol under which trainees can evaluate patients with bone and mineral disorders 4) to provide a pool of patients with bone and mineral disorders, questions about which may serve as the basis for future studies.
Within this study patients will undergo clinically-indicated testing and possibly receive treatment which will be limited to FDA-approved medications.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 who will help fulfill the objectives laid out in the protocol.
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 and not able to give informed consent.
Patients with serious, uncontrolled metabolic organ system dysfunction (decompensated heart failure, diabetes, etc.).
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 010184, 01-D-0184 |
| Study First Received: | September 28, 2001 |
| Last Updated: | October 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00024804 History of Changes |
| Health Authority: | United States: Federal Government |
|
Bone Dysplasia Fragility Osteomalacia Osteoporosis |
Dysplasia Osteomalacia Bone Diseases Skeletal Disease |
|
Musculoskeletal Diseases Osteoporosis Osteomalacia Bone Diseases |
|
Musculoskeletal Diseases Bone Diseases |
