Bone Mineral DensityNCT02355340
Bone Mineral Density Status in Pediatric and Adolescent Survivors of Childhood Cancer With History of Bone Fracture
An observational study of Bone Mineral Density and Childhood Cancer Survivors, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This research study is evaluating bone mineral density in childhood cancer survivors who have a history of bone fracture. Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Bone Mineral Density, Childhood Cancer Survivors
- What is being tested?
- Dual energy x-ray absorptiometry (DXA) and Peripheral quantitative computed tomography (pQCT)
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to 7 Jun 2024
- 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 8 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Childhood cancer survivors, currently age 8-20 with a history of bone fracture after completion of chemotherapy.
Who may be able to join
- History of childhood cancer
- Age ≥ 8 years and < 20 years at time of enrollment
- ≥ 2 years since completion of cancer-directed therapy for first cancer
- Received chemotherapy for treatment of childhood cancer
- History of bone fracture after the conclusion of chemotherapy*
- Not currently receiving cancer-directed therapy
- Signed written informed consent (by parent if patient is < 18 years of age, or by patient, if he or she is ≥18 years of age)
- Patient assent for those ≥10 years of age and < 18 years of age for whom a parent provides informed consent (*History of bone fracture will be based on patient/parent report of fracture occurrence and will be confirmed in review of the medical record whenever feasible.)
Who cannot join
- Current treatment with bisphosphonates (as of time of enrollment)
- Current treatment with the anticonvulsant depakote (at time of enrollment)
- Currently pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
This research study is evaluating bone mineral density in childhood cancer survivors who have a history of bone fracture.
Read the detailed description
The purpose of this research study is to learn more about the status of bones in children and young-adults who have had bone fractures after treatment for childhood cancer. Bone complications including fracture can be important issues for some childhood cancer survivors. In this study we are measuring bone mineral density in children and young adults who have had bone fracture after treatment for childhood cancer. We will measure bone mineral density in two ways. We will use: 1) dual energy x-ray absorptiometry (also known as DXA), and 2) peripheral quantitative computed tomography (also known as pQCT).
- Conditions
- Bone Mineral Density, Childhood Cancer Survivors
- Being tested
- Dual energy x-ray absorptiometry (DXA), Peripheral quantitative computed tomography (pQCT)
- Keywords
- Bone mineral density, Childhood cancer survivors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual energy x-ray absorptiometry (DXA)Other
Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.
Peripheral quantitative computed tomography (pQCT)Other
Subjects will undergo pQCT assessment of radius and tibia.
| Study group | Role | What they receive |
|---|---|---|
| DXA and pQCT Scan | * Dual energy x-ray absorptiometry (DXA): Assessment of bone mineral density
* Peripheral quantitative computed tomography (pQCT): Assessment of bone mineral density Receives: Other: Dual energy x-ray absorptiometry (DXA); Other: Peripheral quantitative computed tomography (pQCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body BMD (total body less head) and lumbar spine BMD
DXA assessment (z-score)
Measured: Participants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy
Volumetric BMD of distal radius
pQCT assessment
Measured: Participants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy
Secondary outcomes (1)
25-hydroxy vitamin D level
Measured: Participants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2024
- Study completion7 Jun 2024
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 Dana-Farber Cancer InstituteThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynda Vrooman, MD, Dana-Farber Cancer Institute
- Investigators
- Lynda Vrooman, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355340
- Sponsor's protocol ID
- 14-411
- Status last verified
- Aug 2024
- First submitted
- 23 Jan 2015
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Density Status in Pediatric and Adolescent Survivors of Childhood Cancer With History of Bone Fracture
- ClinicalTrials.gov ID
- NCT02355340
- Acronym / sponsor ID
- 14-411
- Conditions
- Bone Mineral Density, Childhood Cancer Survivors
- Keywords
- Bone mineral density, Childhood cancer survivors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 4 Feb 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.
This research study is evaluating bone mineral density in childhood cancer survivors who have a history of bone fracture.
Detailed description
The purpose of this research study is to learn more about the status of bones in children and young-adults who have had bone fractures after treatment for childhood cancer. Bone complications including fracture can be important issues for some childhood cancer survivors. In this study we are measuring bone mineral density in children and young adults who have had bone fracture after treatment for childhood cancer. We will measure bone mineral density in two ways. We will use: 1) dual energy x-ray absorptiometry (also known as DXA), and 2) peripheral quantitative computed tomography (also known as pQCT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DXA and pQCT Scan | – | Other: Dual energy x-ray absorptiometry (DXA), Other: Peripheral quantitative computed tomography (pQCT)* Dual energy x-ray absorptiometry (DXA): Assessment of bone mineral density * Peripheral quantitative computed tomography (pQCT): Assessment of bone mineral density |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Childhood cancer survivors, currently age 8-20 with a history of bone fracture after completion of chemotherapy.
Key inclusion criteria (8 listed)
- History of childhood cancer
- Age ≥ 8 years and < 20 years at time of enrollment
- ≥ 2 years since completion of cancer-directed therapy for first cancer
- Received chemotherapy for treatment of childhood cancer
- History of bone fracture after the conclusion of chemotherapy*
Key exclusion criteria (3 listed)
- Current treatment with bisphosphonates (as of time of enrollment)
- Current treatment with the anticonvulsant depakote (at time of enrollment)
- Currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual energy x-ray absorptiometry (DXA)Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density. | Other | DXA and pQCT Scan |
| Peripheral quantitative computed tomography (pQCT)Subjects will undergo pQCT assessment of radius and tibia. | Other | DXA and pQCT Scan |
Primary outcome
Total body BMD (total body less head) and lumbar spine BMD
Time frame: Participants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy
DXA assessment (z-score)
Volumetric BMD of distal radius
Time frame: Participants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy
pQCT assessment
1 secondary outcome
25-hydroxy vitamin D level
Time frame: Participants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy
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 6 Aug 2024.
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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.
Lynda Vrooman, MD principal investigator
Dana-Farber Cancer Institute
2 sites 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 Childhood Cancer Survivors, run by Dana-Farber Cancer Institute at 2 sites 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 8 inclusion and 3 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Total body BMD (total body less head) and lumbar spine BMD (time frame: Participants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy). 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 6 Aug 2024.