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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277562
• Other study ID #: 10005
• Status: Completed
• Phase: N/A
• First received: January 13, 2011
• Last updated: June 3, 2015
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Osteopenia
• Osteoporosis
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
City of Hope Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine prevalence of secondary causes of bone loss in patients with new diagnosis of osteopenia/o		2 years	No