Clinical trial NCT02355340: Bone Mineral Density Status in Pediatric and Adolescent Survivors of Childhood Cancer With History of Bone Fracture
Official title: Bone Mineral Density Status in Pediatric and Adolescent Survivors of Childhood Cancer With History of Bone Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Mineral Density
Childhood Cancer Survivors
Keywords: Bone mineral density
Childhood cancer survivors
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Childhood cancer survivors, currently age 8-20 with a history of bone fracture after completion of chemotherapy.

Brief summary: 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).

Eligibility criteria: Inclusion Criteria:

* 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.)

Exclusion Criteria:

* Current treatment with bisphosphonates (as of time of enrollment)
* Current treatment with the anticonvulsant depakote (at time of enrollment)
* Currently pregnant

Primary outcomes:
measure: Total body BMD (total body less head) and lumbar spine BMD
timeFrame: Participants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy
measure: Volumetric BMD of distal radius
timeFrame: Participants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy
Secondary outcomes:
measure: 25-hydroxy vitamin D level
timeFrame: Participants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Lynda Vrooman, MD
role: PRINCIPAL_INVESTIGATOR
References: