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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
City of Hope Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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