Breast CancerNCT01277562
Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer
An observational study of Breast Cancer and Prostate Cancer, run by City of Hope Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Osteopenia
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2011to 4 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with newly diagnosed osteopenia and osteoporosis with diagnosis of non-metastatic breast or prostate cancer
Who may be able to join
- Diagnosis of nonmetastatic breast cancer or diagnosis of nonmetastatic prostate cancer
- Measurement of bone mineral density by Dual Energy X-ray Absorptiometry (DEXA) within 6 months of enrollment into study.
- Patients of all ages are eligible but need to qualify for standard DEXA screening
- Patients of all performance status are eligible
- Patients are able to give informed consent
Who cannot join
- Patients previously diagnosed or treated for osteoporosis/osteopenia
- Stage IV cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
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.
Read the 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.
- 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.
- Conditions
- Breast Cancer, Prostate Cancer, Osteopenia, Osteoporosis
- Keywords
- Breast Cancer, Prostate Cancer, Osteopenia, Osteoporosis, Secondary causes of bone loss
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine prevalence of secondary causes of bone loss in patients with new diagnosis of osteopenia/o
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study start20 Jan 2011
- Primary completion3 Dec 2012
- Study completion4 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arti Hurria, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277562
- Sponsor's protocol ID
- 10005
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2011
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer
- ClinicalTrials.gov ID
- NCT01277562
- Acronym / sponsor ID
- 10005
- Conditions
- Breast Cancer, Prostate Cancer, Osteopenia, Osteoporosis
- Keywords
- Breast Cancer, Prostate Cancer, Osteopenia, Osteoporosis, Secondary causes of bone loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 20 Jan 2011 (actual)
- Primary completion
- 3 Dec 2012 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with newly diagnosed osteopenia and osteoporosis with diagnosis of non-metastatic breast or prostate cancer
Key inclusion criteria (5 listed)
- Diagnosis of nonmetastatic breast cancer or diagnosis of nonmetastatic prostate cancer
- Measurement of bone mineral density by Dual Energy X-ray Absorptiometry (DEXA) within 6 months of enrollment into study.
- Patients of all ages are eligible but need to qualify for standard DEXA screening
- Patients of all performance status are eligible
- Patients are able to give informed consent
Key exclusion criteria (2 listed)
- Patients previously diagnosed or treated for osteoporosis/osteopenia
- Stage IV cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine prevalence of secondary causes of bone loss in patients with new diagnosis of osteopenia/o
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arti Hurria, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Prostate Cancer, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine prevalence of secondary causes of bone loss in patients with new diagnosis of osteopenia/o (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.