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

NCT02355340 | Completed

• 1 other identifier: 14-411
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Bone Mineral Density; Childhood Cancer Survivors

Keywords

Bone mineral density; Childhood cancer survivors

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• 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

Study Arms (1)

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

Other: Dual energy x-ray absorptiometry (DXA); Other: Peripheral quantitative computed tomography (pQCT)

Interventions

Dual energy x-ray absorptiometry (DXA) OTHER

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

DXA and pQCT Scan

Peripheral quantitative computed tomography (pQCT) OTHER

Subjects will undergo pQCT assessment of radius and tibia.

DXA and pQCT Scan

Eligibility Criteria

• Age: 8 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Childhood cancer survivors, currently age 8-20 with a history of bone fracture after completion of chemotherapy.

You may qualify if:

• 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.)

You may not qualify if:

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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Lynda Vrooman, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: February 4, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2024
• Study Completion: June 7, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

US (2)