NCT02561182

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2019

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

3.7 years

First QC Date

September 23, 2015

Last Update Submit

January 23, 2022

Conditions

Bone Mineral DensityVascular Malformations

Outcome Measures

Primary Outcomes (2)

  • Evidence of decreased bone density in patients with vascular malformations, confirmed by DEXA scans

    One year

  • 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

    One year

Study Arms (1)

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

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Vascular Malformations

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Megha M Tollefson, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 25, 2015

Study Start

September 1, 2015

Primary Completion

May 23, 2019

Study Completion

May 23, 2019

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

US(1)