Bone DensityNCT00603551
Screening of Bone Mineral Density in Women Who Have Received Chemotherapy
An observational study of Bone Density and Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The hypothesis is that postmenopausal women who have received chemotherapy have a greater bone loss than the same age controls. The aim of this study is to obtain baseline bone mineral density (BMD) data on women with breast and gynecological cancers who have received chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bone Density, Cancer
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Dec 2009
- 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
Study population: The study population consists of postmenopausal women with breast or gynecological cancers who were treated with chemotherapy. The subjects either received their chemotherapy or follow-up at the Hollings Cancer Center at the Medical University of South Carolina.
Who may be able to join
- Postmenopausal woman
- Diagnosed with breast or gynecological cancer
- Treated with chemotherapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
The hypothesis is that postmenopausal women who have received chemotherapy have a greater bone loss than the same age controls. The aim of this study is to obtain baseline bone mineral density (BMD) data on women with breast and gynecological cancers who have received chemotherapy. By comparing the Z scores of postmenopausal women who have received chemotherapy with age matched controls this hypothesis can be evaluated. Another goal of the study is to compare the T-score of a Heel Bone Density Scan to the T-score of the DXA Scan to see if there is a good correlation between peripheral and DXA scores.
Read the detailed description
It is generally accepted that women who develop breast cancer have an increased bone mineral density (BMD) probably due to endogenous estrogen production. After menopause, BMD decreases rather rapidly particularly during the first years after natural menopause. Bone loss typically is more rapid and severe in a premature induced menopause (surgical, chemotherapeutically, or hormonal). The bone loss appears to be more rapid and at an earlier age which advances bone age to a greater degree than actual age. Chemotherapeutically-induced menopause accelerates this process by an average of 10 years. GnRH agonist in premenopausal women causes amenorrhea in >95% with associated loss of both cortical and trabecular bone. In women undergoing ovarian ablation therapy, losses in bone mass as high as 13% have been reported in the first year of treatment. Premenopausal women who by treatment become amenorrheic remain amenorrheic posttreatment in the vast majority of cases. Adjuvant therapy for cancer can exaggerate bone mineral density loss. Chemotherapy may have an effect on estrogen levels but may also have an effect on bone loss via direct cytotoxic effect on bone cells.
Although there is data concerning BMD in patients who have received chemotherapy as children and in men with prostate cancer, there is very little data concerning BMD in gynecologic oncology patients who have received chemotherapy. Several different chemotherapeutic agents have been incriminated in their effects on the bone mineral density. The alkylating drugs, particularly Cytoxan, have been shown to decrease bone mineral density. Methotrexate and more recently the taxanes appear to have the same effect. Since most chemotherapy today is given as a combination, one or more of the cytoxic agents on the bone are included and therefore this study will evaluate any postmenopausal women who has received chemotherapy.
Data collection:
Women participating in this study will undergo two scans: a Heel Scan which measures the bone mineral density in the heel area and a DXA scan which measures bone mineral density in the lumbar region of the spine and the hip. Both scans provide a T-score and a Z-score for the subject.
- Conditions
- Bone Density, Cancer
- Keywords
- Osteoporosis, Cancer, Chemotherapy, Bone Density, DXA Scan, Heel Scan
- Medical subject headings
- Neoplasms, 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 |
|---|---|---|
| Chemotherapy | Postmenopausal women who have been diagnosed with a breast or gynecological cancer and who have undergone chemotherapy as a result of that diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Z-score of the DXA scan compared to age-matched controls
Measured: Once, at enrollment
Secondary outcomes (1)
The T-score of the Heel Scan compared to the T score of the DXA Scan
Measured: Once, at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startNov 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DensityStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer, National Center for Research Resources (NCRR)
- Investigators
- William Creasman, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603551
- Sponsor's protocol ID
- HR # 16417
- Other IDs
- Wyeth Protocol # 0713X-102016, GCRC Protocol # 744, HCC CTO # 101019
- Status last verified
- Jul 2008
- First submitted
- 17 Jan 2008
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Bone Mineral Density in Women Who Have Received Chemotherapy
- ClinicalTrials.gov ID
- NCT00603551
- Acronym / sponsor ID
- HR # 16417
- Conditions
- Bone Density, Cancer
- Keywords
- Osteoporosis, Cancer, Chemotherapy, Bone Density, DXA Scan, Heel Scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer, National Center for Research Resources (NCRR)
- Study start
- Nov 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Jan 2008 (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 hypothesis is that postmenopausal women who have received chemotherapy have a greater bone loss than the same age controls. The aim of this study is to obtain baseline bone mineral density (BMD) data on women with breast and gynecological cancers who have received chemotherapy. By comparing the Z scores of postmenopausal women who have received chemotherapy with age matched controls this hypothesis can be evaluated. Another goal of the study is to compare the T-score of a Heel Bone Density Scan to the T-score of the DXA Scan to see if there is a good correlation between peripheral and DXA scores.
Detailed description
It is generally accepted that women who develop breast cancer have an increased bone mineral density (BMD) probably due to endogenous estrogen production. After menopause, BMD decreases rather rapidly particularly during the first years after natural menopause. Bone loss typically is more rapid and severe in a premature induced menopause (surgical, chemotherapeutically, or hormonal). The bone loss appears to be more rapid and at an earlier age which advances bone age to a greater degree than actual age. Chemotherapeutically-induced menopause accelerates this process by an average of 10 years. GnRH agonist in premenopausal women causes amenorrhea in >95% with associated loss of both cortical and trabecular bone. In women undergoing ovarian ablation therapy, losses in bone mass as high as 13% have been reported in the first year of treatment. Premenopausal women who by treatment become amenorrheic remain amenorrheic posttreatment in the vast majority of cases. Adjuvant therapy for cancer can exaggerate bone mineral density loss. Chemotherapy may have an effect on estrogen levels but may also have an effect on bone loss via direct cytotoxic effect on bone cells.
Although there is data concerning BMD in patients who have received chemotherapy as children and in men with prostate cancer, there is very little data concerning BMD in gynecologic oncology patients who have received chemotherapy. Several different chemotherapeutic agents have been incriminated in their effects on the bone mineral density. The alkylating drugs, particularly Cytoxan, have been shown to decrease bone mineral density. Methotrexate and more recently the taxanes appear to have the same effect. Since most chemotherapy today is given as a combination, one or more of the cytoxic agents on the bone are included and therefore this study will evaluate any postmenopausal women who has received chemotherapy.
Data collection:
Women participating in this study will undergo two scans: a Heel Scan which measures the bone mineral density in the heel area and a DXA scan which measures bone mineral density in the lumbar region of the spine and the hip. Both scans provide a T-score and a Z-score for the subject.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | – | –Postmenopausal women who have been diagnosed with a breast or gynecological cancer and who have undergone chemotherapy as a result of that diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of postmenopausal women with breast or gynecological cancers who were treated with chemotherapy. The subjects either received their chemotherapy or follow-up at the Hollings Cancer Center at the Medical University of South Carolina.
Key inclusion criteria (3 listed)
- Postmenopausal woman
- Diagnosed with breast or gynecological cancer
- Treated with chemotherapy
Key exclusion criteria (0 listed)
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
The Z-score of the DXA scan compared to age-matched controls
Time frame: Once, at enrollment
1 secondary outcome
The T-score of the Heel Scan compared to the T score of the DXA Scan
Time frame: Once, at enrollment
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 19 Jun 2018.
Related trials for Bone Density
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Recruiting
Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates
Mandibular Fractures
Recruiting
Digital Eye®-Assisted Bone Density Classification and Primary Dental Implant Stability.
Bone Mineral Density, Primary Implant Stability
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.
William Creasman, MD principal investigator
Medical University of South Carolina
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 Bone Density and Cancer, run by Medical University of South Carolina 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 3 inclusion and 0 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 19 Jun 2018. 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?
The Z-score of the DXA scan compared to age-matched controls (time frame: Once, at enrollment). 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 19 Jun 2018.