Bone Health in Patients With Overgrowth
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|ClinicalTrials.gov Identifier: NCT02561182|
Recruitment Status : Recruiting
First Posted : September 25, 2015
Last Update Posted : January 22, 2020
|Condition or disease|
|Bone Mineral Density Vascular Malformations|
It is known that patients with complex vascular malformation are at risk of decreased bone density and even vanishing bone disease. However, what is not known is if patients with OGS are at decreased bone density at locations that are distant from the vascular malformation.
This study will look at bone health in patient's with OGS in a cross sectional fashion. If they are found to be at a particular risk for decreased bone density then this can be addressed in early childhood, through nutrition and activity recommendations.
The study will consist of 15 participants, all who have a known clinical diagnosis of an overgrowth syndrome, and will be >5 years old so that they can co operate with a DEXA or Xtreme CT scan.
- They will be asked specific questions regarding medical and family history and an intake form will be filled out.
- The height, weight, body mass index and Tanner stage measurements will be recorded during this visit.
- Photos of the affected area(s) will be taken, however, this is optional.
- A urine pregnancy test will be done in all females of childbearing potential .
- Laboratory studies will be performed in all patients.
- A 24-hour urine sample will be collected from adults who are able and willing; in children and in those not able or unwilling to provide a 24-hour urine, a spot urine will be collected.
- Bone age will be assessed via plain film of the wrist
- Bone density will be assessed for each patient via DEXA scan
- Cortical and trabecular parameters and bone strength will be assessed by HRpQCT
|Study Type :||Observational|
|Estimated Enrollment :||15 participants|
|Official Title:||Bone Health in Patients With Overgrowth|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
|Patients aged 5 years old and with a known diagnosis of a OGS|
- Evidence of decreased bone density in patients with vascular malformations, confirmed by DEXA scans [ Time Frame: One year ]
- Evidence of decreased bone density in patients with vascular malformations, confirmed by serum specific bone markers [ Time Frame: One year ]Bone markers : Alkaline phosphatase; albumin; PTH; 1-25 dihydroxyvitamin D, 25- hydroxyvitamin D
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561182
|Contact: Henry Nguyen, MD||Nguyen.Henry@mayo.edu|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55901|
|Contact: Henry Nguyen, MD Nguyen.Henry@mayo.edu|
|Principal Investigator: Megha M Tollefson, MD|
|Principal Investigator:||Megha M Tollefson, MD||Mayo Clinic|