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Completed

NCT Number: NCT02355340

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

This research study is evaluating bone mineral density in childhood cancer survivors who have a history of bone fracture.

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Key information

Age range

8 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital, Boston, Massachusetts, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Feb 4, 2015
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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