Bone Health in Patients With Overgrowth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-05-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Growth Hormone and Bone in Obesity

NCT01724489

Obesity Osteopenia

COMPLETED NA

Myeloproliferative Neoplasms and Bone Structure

NCT01816022

Polycythemia Vera Thrombocythemia, Essential Primary Myelofibrosis

UNKNOWN

Clinical Assessment of Patients With High Bone Mass Due to Mutation in Lrp5

NCT01199094

Osteopetrosis

COMPLETED

Bone to Skin Thickness Study: Obese Versus Normal Population

NCT01248182

Fracture

TERMINATED

Bone Structure in Patients With Adult Onset Growth Hormone Deficiency Assessed Using High Resolution Peripheral Quantitative Computed Tomography

NCT02218710

Adult Onset Growth Hormone Deficiency

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Mineral Density Vascular Malformations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No