Clinical trial NCT01277562: Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer
Official title: Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Prostate Cancer
Osteopenia
Osteoporosis
Keywords: Breast Cancer
Prostate Cancer
Osteopenia
Osteoporosis
Secondary causes of bone loss
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with newly diagnosed osteopenia and osteoporosis with diagnosis of non-metastatic breast or prostate cancer

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Determine prevalence of secondary causes of bone loss in patients with new diagnosis of osteopenia/o
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Arti Hurria, MD
role: PRINCIPAL_INVESTIGATOR
References: