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Bone Mineral Density Status in Pediatric and Adolescent Survivors of Childhood Cancer With History of Bone Fracture

Bone Mineral Density Status in Pediatric and Adolescent Survivors of Childhood Cancer With History of Bone Fracture

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02355340
Enrollment
22
Registered
2015-02-04
Start date
2015-05-31
Completion date
2024-06-07
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Mineral Density, Childhood Cancer Survivors

Keywords

Bone mineral density, Childhood cancer survivors

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).

Interventions

Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.

Subjects will undergo pQCT assessment of radius and tibia.

Sponsors

Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 20 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total body BMD (total body less head) and lumbar spine BMDParticipants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapyDXA assessment (z-score)
Volumetric BMD of distal radiusParticipants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapypQCT assessment

Secondary

MeasureTime frame
25-hydroxy vitamin D levelParticipants to undergo a single baseline assessment on day 1; to be measured at ≥ 2 years since completion of cancer-directed therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026