Evaluation and Treatment of Skeletal Diseases

This study is currently recruiting participants.
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00024804
First received: September 28, 2001
Last updated: March 14, 2014
Last verified: December 2013

September 28, 2001
March 14, 2014
September 2001
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Complete list of historical versions of study NCT00024804 on ClinicalTrials.gov Archive Site
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Evaluation and Treatment of Skeletal Diseases
Evaluation and Treatment of Bone and Mineral Disorders

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.

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 bone and mineral disorders has increased 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 for the receipt of tissues and clinical specimens from investigators outside and inside the NIH, 2) to provide a protocol within which patients with common and rare disorders of bone and mineral metabolism can be studied, 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 therapies based on the best professional judgment of the investigators and treatment with medications commercially available under FDA law.

Observational
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Bone Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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  • INCLUSION CRITERIA:

    1. Specimens to be shipped will be either "surgical waste," or the harvesting of the specimen will be allowed for by an IRB-approved protocol at the sending institution. The specimen will be sent with a copy of the signed consent.
    2. Patients of any age, gender, or ethnicity may enroll.
    3. Patients with known or suspected bone disease, as demonstrated by any one of the following: a fracture, or abnormal bone findings on x-ray, CT scan, MRI, or bone densitometry.
    4. Patients with a known or suspected disorder of mineral metabolism, as demonstrated by any one of the following: laboratory measurement above or below the normal NIH laboratory reference values for either blood or urine calcium, phosphorus, magnesium, parathyroid hormone or vitamin D.

EXCLUSION CRITERIA:

  1. Patients not able to give informed consent.
  2. Patients unwilling or unable to abide by procedures of protocol.
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Contact: Michael T Collins, M.D. (301) 496-4913 mc247k@nih.gov
United States
 
NCT00024804
010184, 01-D-0184
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National Institute of Dental and Craniofacial Research (NIDCR)
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Principal Investigator: Michael T Collins, M.D. National Institute of Dental and Craniofacial Research (NIDCR)
National Institutes of Health Clinical Center (CC)
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP