Breast CancerNCT00873808
S0307A, Long-Term Bone Quality in Women With Breast Cancer Enrolled on Clinical Trial SWOG-S0307
An observational study of Breast Cancer, run by SWOG Cancer Research Network at 1 site in United States.
Trial summary
RATIONALE: Gathering information over time from imaging and laboratory tests of women receiving bisphosphonates for breast cancer may help doctors learn more about long-term bone quality and plan the best treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- clodronate disodium, demeclocycline hydrochloride and ibandronate sodium
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Feb 2010
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Concurrently enrolled on clinical trial SWOG-S0307 and receiving bisphosphonates as adjuvant therapy for primary breast cancer
- No rickets, osteogenesis imperfecta, osteosclerosis, or osteomalacia
- No bone fracture since the age of 21 years unless it was caused by trauma
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Weight < 300 lbs
- No hyperparathyroidism
- No serious concurrent or prior anorexia nervosa diagnosed by a physician and causing abnormal menstruation
- No history of hypersensitivity to tetracycline or demeclocycline
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 10 years since prior prednisone at a dose above 5 mg/day for ≥ 3 months
- No prior prednisone before diagnosis of breast cancer
- No prior bisphosphonate therapy
- No concurrent anticonvulsant medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195-6043
About this study
Official title: Long-Term Bone Quality in Women With Breast Cancer (A Companion Study to S0307)
RATIONALE: Gathering information over time from imaging and laboratory tests of women receiving bisphosphonates for breast cancer may help doctors learn more about long-term bone quality and plan the best treatment. Tetracycline hydrochloride and demeclocycline hydrochloride can mark the new growth of the bone, so it may be seen better under a microscope.
PURPOSE: This clinical trial is studying long-term bone quality in women with breast cancer enrolled on clinical trial SWOG-S0307.
Read the detailed description
OBJECTIVES:
- To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the histomorphometry of bone biopsies after tetracycline hydrochloride labeling to calculate eroded and osteoid surfaces, mineralization surface, bone formation rate, wall width, and activation frequency.
- To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the backscattered electron imaging of bone to measure average mineralization density as well as distribution of density values.
- To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the micro-computed tomography of bone biopsy specimens to measure bone structure, including bone volume, connectivity, trabecular width, and cortical width.
- To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the biomechanical testing of bone biopsy samples loaded in compression to measure stress-strain relationships, including Young's modulus, yield point, ultimate strain, and work to failure (toughness).
- To characterize bone using classical, non-invasive techniques (i.e., measurement of bone mineral density of spine and hip using dual energy x-ray absorptiometry and analysis of serum biochemical markers of bone formation [i.e., bone specific alkaline phosphatase] and resorption [i.e., N-telopeptide]) after long-term, high-dose bisphosphonates.
OUTLINE: This is a multicenter study.
At baseline (prior to initiating bisphosphonate therapy on SWOG-S0307), patients receive oral tetracycline hydrochloride twice daily on days 1 and 2 and oral demeclocycline hydrochloride twice daily on days 11 and 12. Patients undergo a tetracycline hydrochloride-labeled bone biopsy from the anterior ilium on day 14. At 36 months (for patients who have completed bisphosphonate therapy) or after 30 months of concurrent bisphosphonate therapy, patients receive oral demeclocycline twice daily on days 1 and 2 and oral tetracycline hydrochloride twice daily on days 11 and 12. Patients undergo a demeclocycline hydrochloride-labeled bone biopsy from the anterior ilium on day 14.
Patients undergo dual energy x-ray absorptiometry measurements of the hip and spine at the time of biopsy or within the next 10 weeks. Blood samples are collected for analysis of bone specific alkaline phosphatase and N-telopeptide before and after treatment on the clinical trial.
After completion of study treatment, patients are followed for up to 10 years.
- Conditions
- Breast Cancer
- Being tested
- clodronate disodium, demeclocycline hydrochloride, ibandronate sodium, tetracycline hydrochloride, zoledronic acid
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clodronate disodiumDrug
demeclocycline hydrochlorideDrug
ibandronate sodiumDrug
tetracycline hydrochlorideDrug
zoledronic acidDrug
laboratory biomarker analysisOther
adjuvant therapyProcedure or surgery
computed tomographyProcedure or surgery
dual x-ray absorptiometryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone quality after long-term high-dose bisphosphonates as measured by histomorphometry, mineralization density, micro-computed tomography, and biomechanics of bone biopsy samples
Secondary outcomes (2)
Comparison of the potency of bisphosphonates as measured by changes in bone quality in each treatment group
Correlations among measures of bone formation, structure, mineralization, and strength
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startOct 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: lack of accrual
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 SWOG Cancer Research NetworkThe 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dawn Hershman, MD, Study chair, Herbert Irving Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873808
- Sponsor's protocol ID
- CDR0000614118
- Other IDs
- S0307A, U10CA032102
- Status last verified
- Apr 2013
- First submitted
- 1 Apr 2009
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Bone Quality in Women With Breast Cancer (A Companion Study to S0307)
- ClinicalTrials.gov ID
- NCT00873808
- Acronym / sponsor ID
- CDR0000614118
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 2 Apr 2009 (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.
RATIONALE: Gathering information over time from imaging and laboratory tests of women receiving bisphosphonates for breast cancer may help doctors learn more about long-term bone quality and plan the best treatment. Tetracycline hydrochloride and demeclocycline hydrochloride can mark the new growth of the bone, so it may be seen better under a microscope.
PURPOSE: This clinical trial is studying long-term bone quality in women with breast cancer enrolled on clinical trial SWOG-S0307.
Detailed description
OBJECTIVES:
- To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the histomorphometry of bone biopsies after tetracycline hydrochloride labeling to calculate eroded and osteoid surfaces, mineralization surface, bone formation rate, wall width, and activation frequency.
- To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the backscattered electron imaging of bone to measure average mineralization density as well as distribution of density values.
- To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the micro-computed tomography of bone biopsy specimens to measure bone structure, including bone volume, connectivity, trabecular width, and cortical width.
- To assess if long-term high-dose bisphosphonates alter bone quality as measured by change in the biomechanical testing of bone biopsy samples loaded in compression to measure stress-strain relationships, including Young's modulus, yield point, ultimate strain, and work to failure (toughness).
- To characterize bone using classical, non-invasive techniques (i.e., measurement of bone mineral density of spine and hip using dual energy x-ray absorptiometry and analysis of serum biochemical markers of bone formation [i.e., bone specific alkaline phosphatase] and resorption [i.e., N-telopeptide]) after long-term, high-dose bisphosphonates.
OUTLINE: This is a multicenter study.
At baseline (prior to initiating bisphosphonate therapy on SWOG-S0307), patients receive oral tetracycline hydrochloride twice daily on days 1 and 2 and oral demeclocycline hydrochloride twice daily on days 11 and 12. Patients undergo a tetracycline hydrochloride-labeled bone biopsy from the anterior ilium on day 14. At 36 months (for patients who have completed bisphosphonate therapy) or after 30 months of concurrent bisphosphonate therapy, patients receive oral demeclocycline twice daily on days 1 and 2 and oral tetracycline hydrochloride twice daily on days 11 and 12. Patients undergo a demeclocycline hydrochloride-labeled bone biopsy from the anterior ilium on day 14.
Patients undergo dual energy x-ray absorptiometry measurements of the hip and spine at the time of biopsy or within the next 10 weeks. Blood samples are collected for analysis of bone specific alkaline phosphatase and N-telopeptide before and after treatment on the clinical trial.
After completion of study treatment, patients are followed for up to 10 years.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clodronate disodium | Drug | – |
| demeclocycline hydrochloride | Drug | – |
| ibandronate sodium | Drug | – |
| tetracycline hydrochloride | Drug | – |
| zoledronic acid | Drug | – |
| laboratory biomarker analysis | Other | – |
| adjuvant therapy | Procedure or surgery | – |
| computed tomography | Procedure or surgery | – |
| dual x-ray absorptiometry | Procedure or surgery | – |
Primary outcome
Change in bone quality after long-term high-dose bisphosphonates as measured by histomorphometry, mineralization density, micro-computed tomography, and biomechanics of bone biopsy samples
2 secondary outcomes
Comparison of the potency of bisphosphonates as measured by changes in bone quality in each treatment group
Correlations among measures of bone formation, structure, mineralization, and strength
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
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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.
Dawn Hershman, MD study chair
Herbert Irving Comprehensive Cancer 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, run by SWOG Cancer Research Network 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?
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: withdrawn, as of the sponsor's last update on 10 Apr 2013. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in bone quality after long-term high-dose bisphosphonates as measured by histomorphometry, mineralization density, micro-computed tomography, and biomechanics of bone biopsy samples. 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 10 Apr 2013.