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Protocol Details

A Natural History Study of Bone and Mineral Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

01-D-0184

Sponsoring Institute

National Institute of Dental And Craniofacial Research (NIDCR)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 1 days
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Natural History;
skeletal diseases

Recruitment Keyword(s)

Osteoporosis;
Dysplasia;
Osteomalacia;
Bone Diseases;
Skeletal Disease

Condition(s)

Tumor Induced Osteomalcia;
Osteomalacia;
Familial Tumoral Calcinosis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Dental and Craniofacial Research

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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Eligibility

INCLUSION CRITERIA:

The study population will include participants with known or suspected bone disease and/or with a known or suspected disorder of mineral metabolism. To be eligible to participate in this study, an individual must meet all of the following criteria:

1. Age 1 day of life or older

2. Have a 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, and/or a medical or family history consistent with or suggestive of a bone disease.

3. Have a known or suspected disorder of mineral metabolism, as demonstrated by any one of the following: laboratory measurement above or below the reference values for either blood or urine calcium, phosphorus, magnesium, parathyroid hormone or vitamin D, or other measures of mineral metabolism, and/or a medical or family history consistent with or suggestive of a disorder of mineral metabolism.

EXCLUSION CRITERIA:

1. Subjects unwilling or unable to abide by procedures of protocol.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Rachel I. Gafni, M.D.
National Institute of Dental And Craniofacial Research (NIDCR)
NIHBC 30 BG RM 218
30 CONVENT DR
BETHESDA MD 20892
(301) 594-9924
gafnir@mail.nih.gov

Karen A. Pozo, R.N.
National Institute of Dental And Craniofacial Research (NIDCR)
National Institutes of Health
Building 10
Room 1N103
10 Center Drive
Bethesda, Maryland 20892
(301) 827-1138
karen.pozo@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00024804

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