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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01277562
First received: January 13, 2011
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition
Breast Cancer
Prostate Cancer
Osteopenia
Osteoporosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Determine prevalence of secondary causes of bone loss in patients with new diagnosis of osteopenia/o [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: November 2010
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast Cancer
Non-metastatic breast cancer with recent diagnosis of osteopenia or osteoporosis
Prostate Cancer
Non-metastatic prostate cancer with recent diagnosis of osteopenia or 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adults with newly diagnosed osteopenia and osteoporosis with diagnosis of non-metastatic breast or prostate cancer

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277562

Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Arti Hurria, MD City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01277562     History of Changes
Other Study ID Numbers: 10005
Study First Received: January 13, 2011
Last Updated: March 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
Breast Cancer
Prostate Cancer
Osteopenia
Osteoporosis
Secondary causes of bone loss

Additional relevant MeSH terms:
Breast Neoplasms
Bone Diseases, Metabolic
Osteoporosis
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Bone Diseases
Musculoskeletal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013