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

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ClinicalTrials.gov Identifier: NCT02355340
Recruitment Status : Recruiting
First Posted : February 4, 2015
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Lynda Vrooman, Dana-Farber Cancer Institute

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

Condition or disease Intervention/treatment
Bone Mineral Density Childhood Cancer Survivors Other: Dual energy x-ray absorptiometry (DXA) Other: Peripheral quantitative computed tomography (pQCT)

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).

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Mineral Density Status in Pediatric and Adolescent Survivors of Childhood Cancer With History of Bone Fracture
Study Start Date : May 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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

Other: Peripheral quantitative computed tomography (pQCT)
Subjects will undergo pQCT assessment of radius and tibia.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Childhood cancer survivors, currently age 8-20 with a history of bone fracture after completion of chemotherapy.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355340


Contacts
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Contact: Lynda Vrooman, MD (617) 632-2659 lynda_vrooman@dfci.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lynda Vrooman, MD    617-632-2659    lynda_vrooman@dfci.harvard.edu   
Principal Investigator: Lynda Vrooman, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lynda Vrooman, MD    617-632-2659    lynda_vrooman@dfci.harvard.edu   
Principal Investigator: Lynda Vrooman, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Lynda Vrooman, MD Dana-Farber Cancer Institute

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Responsible Party: Lynda Vrooman, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02355340     History of Changes
Other Study ID Numbers: 14-411
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Keywords provided by Lynda Vrooman, Dana-Farber Cancer Institute:
Bone mineral density
Childhood cancer survivors
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries