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


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Prostate Cancer, Osteopenia, Osteoporosis

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Determine prevalence of secondary causes of bone loss in patients with new diagnosis of osteopenia/o

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Arti Hurria, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Institutional Review Board

Study ID:

10005

NCT ID:

NCT01277562

Start Date:

November 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Prostate Cancer
  • Osteopenia
  • Osteoporosis
  • Breast Cancer
  • Prostate Cancer
  • Osteopenia
  • Osteoporosis
  • Secondary causes of bone loss
  • Breast Neoplasms
  • Bone Diseases, Metabolic
  • Osteoporosis
  • Prostatic Neoplasms

Name

Location

City of Hope Medical CenterDuarte, California  91010