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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 9, 2019
Sponsor:
Information provided by (Responsible Party):
Megha M. Tollefson, M.D., Mayo Clinic

Brief Summary:
The goal of this study is to determine whether or not patients with overgrowth syndromes have decreased bone density.

Condition or disease
Bone Mineral Density Vascular Malformations

Detailed Description:

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.

Study specifics:

  • 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

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort
Patients aged 5 years old and with a known diagnosis of a OGS



Primary Outcome Measures :
  1. Evidence of decreased bone density in patients with vascular malformations, confirmed by DEXA scans [ Time Frame: One year ]
  2. 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
whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 5 years old and over with a known clinical diagnosis of an overgrowth syndrome such as Klippel-Trenaunay Syndrome, CLOVE syndrome, Proteus syndrome, diffuse capillary malformation with overgrowth, or other unspecified OGS.
Criteria

Inclusion Criteria:

  • Age > 5 years such that the patient is able to cooperate with the DXA scan or Xtreme CT
  • Known clinical diagnosis of an overgrowth syndrome such as Klippel-Trenaunay Syndrome, CLOVE syndrome, Proteus syndrome, diffuse capillary malformation with overgrowth, or other unspecified OGS.

Exclusion Criteria:

  • Age < 5 years
  • Inability to comply with the scan
  • No or uncertain diagnosis of an OGS.
  • Prior bisphosphonate use
  • Systemic steroids in the past 6 months
  • Pregnant women

Information from the National Library of Medicine

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


Contacts
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Contact: Henry Nguyen, MD Nguyen.Henry@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Henry Nguyen, MD       Nguyen.Henry@mayo.edu   
Principal Investigator: Megha M Tollefson, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Megha M Tollefson, MD Mayo Clinic

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Responsible Party: Megha M. Tollefson, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02561182     History of Changes
Other Study ID Numbers: 15-002284
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Vascular Malformations
Congenital Abnormalities
Cardiovascular Abnormalities
Cardiovascular Diseases