Bone Mineral DensityNCT02561182
Bone Health in Patients With Overgrowth
An observational study of Bone Mineral Density and Vascular Malformations, run by Mayo Clinic at 1 site in United States.
Trial summary
The goal of this study is to determine whether or not patients with overgrowth syndromes have decreased bone density. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Bone Mineral Density, Vascular Malformations
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 23 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Bone Mineral Density, Vascular Malformations
- Medical subject headings
- Vascular Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients aged 5 years old and with a known diagnosis of a OGS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of decreased bone density in patients with vascular malformations, confirmed by DEXA scans
Measured: 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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion23 May 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Mineral DensityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megha M. Tollefson, M.D., Mayo Clinic
- Investigators
- Megha M Tollefson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561182
- Sponsor's protocol ID
- 15-002284
- Status last verified
- Jan 2022
- First submitted
- 23 Sep 2015
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Health in Patients With Overgrowth
- ClinicalTrials.gov ID
- NCT02561182
- Acronym / sponsor ID
- 15-002284
- Conditions
- Bone Mineral Density, Vascular Malformations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine whether or not patients with overgrowth syndromes have decreased bone density.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged 5 years old and with a known diagnosis of a OGS | – | – |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megha M Tollefson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Mineral Density and Vascular Malformations, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of decreased bone density in patients with vascular malformations, confirmed by DEXA scans (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.