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

NCT ID: NCT01277562

Last Updated: 2015-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Prostate Cancer Osteopenia Osteoporosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast Cancer

Non-metastatic breast cancer with recent diagnosis of osteopenia or osteoporosis

No interventions assigned to this group

Prostate Cancer

Non-metastatic prostate cancer with recent diagnosis of osteopenia or osteoporosis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arti Hurria, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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10005

Identifier Type: -

Identifier Source: org_study_id

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