Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer

June 3, 2015 updated by: City of Hope Medical Center
The investigators hypothesis is that secondary causes of bone loss are prevalent in patients with breast and prostate cancer, and those patients with secondary causes of bone loss are at higher risk for treatment related bone loss. The goals of this pilot study are to estimate the prevalence of secondary causes of osteoporosis in a cohort of patients with nonmetastatic breast and prostate cancer with osteopenia and osteoporosis.

Study Overview

Status

Completed

Conditions

Detailed Description

The interaction of aging, cancer, and bone loss is poorly understood. Cancer or cancer therapy could potentially accelerate bone loss and increase the risk for osteopenia or osteoporosis. The hypothesis of this observational study is that secondary causes of bone loss are prevalent in patients with breast and prostate cancer who are high risk for treatment related bone loss. In order to test this hypothesis, this prospective pilot study will systematically evaluate secondary causes of bone loss in a cohort of patients with nonmetastatic breast and prostate cancer with osteopenia/osteoporosis.

  1. Identify patients with nonmetastatic breast cancer newly diagnosed with osteopenia/osteoporosis (Dual Energy X-ray Absorptiometry Bone Density scan T-score average between hip (femoral neck) and spine (L1-L4) of less than -1.0 to -2.5/ less than -2.5, respectively).
  2. Identify patients with nonmetastatic prostate cancer newly diagnosed with osteopenia/osteoporosis (Dual Energy X-ray Absorptiometry Bone Density scan T-score average between hip (femoral neck) and spine (L1-L4) of less than -1.0 to -2.5/ less than -2.5, respectively).
  3. Refer patient to City of Hope Endocrinology Osteoporosis Clinic.
  4. Approach patient in consecutive order in which they have been referred to Endocrinology Osteoporosis Clinic.
  5. Describe the study to the patient: patient consents or refuses.
  6. Once consented, the patient's medical records are reviewed and Dual Energy X-ray Absorptiometry Bone Density reports are obtained from City of Hope records or the screening medical institution records to confirm diagnosis of osteopenia/osteoporosis or normal bone health.
  7. Study participants will undergo an evaluation for secondary causes of bone per standard of care with patient questionnaires.
  8. Furthermore, laboratory tests that support secondary causes of bone loss will be retrospectively collected via chart review.

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults with newly diagnosed osteopenia and osteoporosis with diagnosis of non-metastatic breast or prostate cancer

Description

Inclusion Criteria

  1. Diagnosis of nonmetastatic breast cancer or diagnosis of nonmetastatic prostate cancer
  2. Measurement of bone mineral density by Dual Energy X-ray Absorptiometry (DEXA) within 6 months of enrollment into study.
  3. Patients of all ages are eligible but need to qualify for standard DEXA screening
  4. Patients of all performance status are eligible
  5. Patients are able to give informed consent

Exclusion Criteria

  1. Patients previously diagnosed or treated for osteoporosis/osteopenia
  2. Stage IV cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast Cancer
Non-metastatic breast cancer with recent diagnosis of osteopenia or osteoporosis
Prostate Cancer
Non-metastatic prostate cancer with recent diagnosis of osteopenia or osteoporosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine prevalence of secondary causes of bone loss in patients with new diagnosis of osteopenia/o
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Arti Hurria, MD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 13, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (Estimate)

January 17, 2011

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10005 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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