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

Bone Mineral Density Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02355340
• Other study ID #: 14-411
• Status: Recruiting
• Start date: May 2015
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: Dana-Farber Cancer Institute
• Contact: Lynda Vrooman, MD
• Phone: (617) 632-2659
• Email: lynda_vrooman[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Mineral Density
• Childhood Cancer Survivors
• Fractures, Bone

Intervention

Other:
• Dual energy x-ray absorptiometry (DXA)
Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.
• Peripheral quantitative computed tomography (pQCT)
Subjects will undergo pQCT assessment of radius and tibia.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total body BMD (total body less head) and lumbar spine BMD	DXA assessment (z-score)	Participants to undergo a single baseline assessment on day 1; to be measured at = 2 years since completion of cancer-directed therapy
Primary	Volumetric BMD of distal radius	pQCT assessment	Participants to undergo a single baseline assessment on day 1; to be measured at = 2 years since completion of cancer-directed therapy
Secondary	25-hydroxy vitamin D level		Participants to undergo a single baseline assessment on day 1; to be measured at = 2 years since completion of cancer-directed therapy