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CompletedNCT02561182Updated Jan 25, 2022

Bone Health in Patients With Overgrowth

An observational study in Bone Mineral Density and Vascular Malformations, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2022-01-25.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
5 Years and older
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Bone Mineral Density
  • Vascular Malformations

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03

In context

Vascular Malformations

83 studies on the registry are indexed under Vascular Malformations; 28 are open to participants now.

This study's enrollment of 30 is below the median of 120 across 31 observational studies indexed under Vascular Malformations.

Browse Vascular Malformations studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients aged 5 years old and with a known diagnosis of a OGS
06

What researchers measure

Primary outcomes

  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

    Bone markers : Alkaline phosphatase; albumin; PTH; 1-25 dihydroxyvitamin D, 25- hydroxyvitamin D

    Time frame: One year

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55901, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02561182
Lead sponsor
Mayo Clinic
Responsible party
Megha M. Tollefson, M.D. (PI, Mayo Clinic) — Principal investigator
First posted
Sep 25, 2015
Start date
Sep 2015
Primary completion
May 23, 2019
Completion
May 23, 2019
Last update
Jan 25, 2022

Study contacts

Megha M Tollefson, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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