Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01277562|
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : June 8, 2015
|Condition or disease|
|Breast Cancer Prostate Cancer Osteopenia Osteoporosis|
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.
- 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).
- 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).
- Refer patient to City of Hope Endocrinology Osteoporosis Clinic.
- Approach patient in consecutive order in which they have been referred to Endocrinology Osteoporosis Clinic.
- Describe the study to the patient: patient consents or refuses.
- 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.
- Study participants will undergo an evaluation for secondary causes of bone per standard of care with patient questionnaires.
- Furthermore, laboratory tests that support secondary causes of bone loss will be retrospectively collected via chart review.
|Study Type :||Observational|
|Actual Enrollment :||56 participants|
|Observational Model:||Case Control|
|Official Title:||Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Non-metastatic breast cancer with recent diagnosis of osteopenia or osteoporosis
Non-metastatic prostate cancer with recent diagnosis of osteopenia or osteoporosis
- Determine prevalence of secondary causes of bone loss in patients with new diagnosis of osteopenia/o [ Time Frame: 2 years ]
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): NCT01277562
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Arti Hurria, MD||City of Hope Medical Center|