Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-29 @ 11:46 PM
Study NCT ID:
NCT00024804
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2001-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Natural History Study of Bone and Mineral Disorders
Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Organization:
Study Overview
Official Title:
A Natural History Study of Bone and Mineral Disorders
Status:
RECRUITING
Status Verified Date:
2025-12-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Study Description:
To evaluate participants with bone and mineral disorders at the NIH Clinical Center and obtain tissue and clinical specimens from outside institutions
Objectives:
Primary Objective:
Provide a protocol within which participants with common and rare disorders of bone and mineral metabolism can be studied, evaluated and treated at NIH.
Secondary Objectives:
To obtain tissue and clinical specimens (including but not limited to blood, urine, nucleic acids, skin and bone) and data collected at outside institutions and the NIH Clinical Center from participants with various bone and mineral disorders.
Tertiary/Exploratory Objective:
Generate a pool of participants with bone and mineral disorders, from which research questions could arise and future clinical research studies may be generated.
Endpoints:
Primary Endpoint:
Medical evaluation with clinical assessments performed at time points specific to each participant s diagnosis. Analysis of research and participant outcome data will be performed.
Secondary Endpoint:
Genetic and/or biochemical assessments of surgical waste material from the NIH Clinical Center or other medical facilities.
Tertiary/Exploratory Endpoint:
Development of a database containing information from enrolled participants with bone and mineral disorders and annotated specimens and data.
To evaluate participants with bone and mineral disorders at the NIH Clinical Center and obtain tissue and clinical specimens from outside institutions
Objectives:
Primary Objective:
Provide a protocol within which participants with common and rare disorders of bone and mineral metabolism can be studied, evaluated and treated at NIH.
Secondary Objectives:
To obtain tissue and clinical specimens (including but not limited to blood, urine, nucleic acids, skin and bone) and data collected at outside institutions and the NIH Clinical Center from participants with various bone and mineral disorders.
Tertiary/Exploratory Objective:
Generate a pool of participants with bone and mineral disorders, from which research questions could arise and future clinical research studies may be generated.
Endpoints:
Primary Endpoint:
Medical evaluation with clinical assessments performed at time points specific to each participant s diagnosis. Analysis of research and participant outcome data will be performed.
Secondary Endpoint:
Genetic and/or biochemical assessments of surgical waste material from the NIH Clinical Center or other medical facilities.
Tertiary/Exploratory Endpoint:
Development of a database containing information from enrolled participants with bone and mineral disorders and annotated specimens and data.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 01-D-0184 | None | None | View |