A Natural History Study of Bone and Mineral Disorders (NCT00024804) | Clinical Trial Compass
RecruitingNot Applicable
A Natural History Study of Bone and Mineral Disorders
United States1,000 participantsStarted 2001-11-19
Plain-language 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.
Who can participate
Age range
1 Day – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 1 day of life or older
. 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a natural history study focused on collecting clinical and research specimens rather than testing a treatment, what does participation actually involve day-to-day, and would it change any of my current care for my bone or mineral disorder?
2This study covers several different conditions including tumor-induced osteomalacia, osteomalacia, and familial tumoral calcinosis — can you help me understand whether my specific diagnosis is a good fit for what researchers are trying to learn here?
3What kinds of specimens or data would be collected from me, how often would I need to come in, and are there any risks or burdens associated with the collection process that I should weigh before deciding?
4Since this is listed as a natural history study with no assigned phase, it's designed to observe rather than treat — does joining this study mean I might delay or miss out on standard treatments that could help me now?
5Are there other treatment trials or standard-of-care options for my condition that my care team thinks I should consider alongside or before enrolling in an observational study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Collection of clinical and research specimens
Timeframe: 10 years
Trial details
NCT IDNCT00024804
SponsorNational Institute of Dental and Craniofacial Research (NIDCR)