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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

January 13, 2011
March 25, 2013
November 2010
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01277562 on ClinicalTrials.gov Archive Site
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Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer
Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer

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.

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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

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

  • Breast Cancer
  • Prostate Cancer
  • Osteopenia
  • Osteoporosis
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  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
Not Provided
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01277562
10005
Yes
City of Hope Medical Center
City of Hope Medical Center
Not Provided
Principal Investigator: Arti Hurria, MD City of Hope Medical Center
City of Hope Medical Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP