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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 28, 2001 | ||||||||
| Last Updated Date | October 9, 2009 | ||||||||
| Start Date ICMJE | September 2001 | ||||||||
| Estimated Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
Incidence of and mortality from lung cancer during intervention (ended April 1993) and post-intervention. | ||||||||
| Change History | Complete list of historical versions of study NCT00024804 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
Other cancers, Major coronary disease, Stroke, Diabetes, Dementia, Symptoms of angina pectoris, intermittent claudicatin and chronic obstructive pulmonary disease | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation and Treatment of Skeletal Diseases | ||||||||
| Official Title ICMJE | Evaluation and Treatment of Bone and Mineral Disorders | ||||||||
| Brief 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. |
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| Detailed Description | 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 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 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 and procedures. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE | Bone Disease | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 99999999 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
3.1 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. 3.2 Patients of any age, gender, or ethnicity may enroll. 3.3 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. 3.4 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: 3.4 Patients not able to give informed consent. 3.5 Patients unwilling or unable to abide by procedures of protocol. |
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00024804 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 010184, 01-D-0184 | ||||||||
| Study Sponsor ICMJE | National Institute of Dental and Craniofacial Research (NIDCR) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | July 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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