Breast CancerPhase 1/2NCT00904423
Ph I/II of Vitamin D on Bone Mineral Density & Markers of Bone Resorption
A Phase 1/2 study testing Vitamin D in people with Breast Cancer and Bone Diseases, run by Mark Pegram at 1 site in United States.
Trial summary
Aromatase inhibitors are potent suppressors of breast cancer growth, but side effects include bone loss, fractures, arthralgias and myalgias. We hypothesize vitamin D administration might be beneficial in treating these symptoms and to protect bone. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer, Bone Diseases
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 3.1.1 All postmenopausal women with histology-confirmed invasive primary breast cancer, who have completed primary surgical or radiotherapy (XRT) with or without adjuvant chemotherapy and are candidates to receive adjuvant therapy with aromatase inhibitors will be screened for eligibility. Postmenopausal is defined as satisfying one or more of the following criteria: having had bilateral oophorectomy; aged more than 60 years; or aged 55-59 years with an intact uterus and amenorrheic for at least 12 months; or if amenorrheic for less than 12 months (after receiving hysterectomy, hormone therapy or chemotherapy).
- 3.1.2 At the time of study enrollment, participants will have completed primary surgical or XRT with or without adjuvant chemotherapy. Chemotherapy will be completed at least 28 days prior to enrollment.
- 3.1.4 Participants will be women between 18-85 years of age. Women and minorities will be actively recruited. Though breast cancer extremely rarely occurs in children and men, this study will only recruit adult females.
- 3.1.5 Participants will have a life expectancy of at least 5 years.
- 3.1.6 Participants will have Eastern Clinical Oncology Group (ECOG) performance status 0-2.
- 3.1.7 Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- 3.2.1 Medications affecting bone metabolism (bisphosphonates, anticonvulsants, chronic heparin therapy, chronic glucocorticoid use > 5 mg/day prednisone or equivalent, teriparatide).
- 3.2.2 Use of any investigational drug within past 90 days.
- 3.2.3 Metastatic breast cancer. High risk for osteoporosis/fractures (BMD < -2.0, history of non-traumatic fracture). Hyperparathyroidism Hypercalcemia Hypercalciuria (fasting spot urine calcium/creatinine ratio >0.20) History of renal stones Renal failure with creatinine over 2.0
- 3.2.4 Considering that vitamin D3 is produced by the human body, allergy to vitamin D3 is not expected to develop. Subjects with known history of allergic reaction to compounds used to manufacture capsules (rice powder) will be excluded form this study.
- 3.2.5 Recent history of excessive alcohol or drug use.
- 3.2.6 As this study will recruit post-menopausal patients, thus pregnant or nursing patients are not part of this investigation.
- 3.2.8 This study is designed to study women after completing primary therapy for breast cancer. Survivors of previous cancers and HIV-positive subjects will not be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase I/II Randomized, Double-blind, Controlled Study to Evaluate Efficacy and Safety of Vitamin D on Bone Mineral Density and Markers of Bone Resorption in Aromatase Inhibitor-induced Bone Loss in Women With Breast Cancer.
Aromatase inhibitors are potent suppressors of breast cancer growth, but side effects include bone loss, fractures, arthralgias and myalgias. We hypothesize vitamin D administration might be beneficial in treating these symptoms and to protect bone.
- Conditions
- Breast Cancer, Bone Diseases
- Being tested
- Vitamin D
- Medical subject headings
- Breast Neoplasms, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Vital nutrients
up to 2400 mg; oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Not described Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spine Bone Mineral Density T Score Change Over One Year
Measured: 1 year
Secondary outcomes (4)
Change in Hip Bone Mineral Density (BMD) T-score
Measured: one year
Bone Turnover Markers
Measured: months 4 and 12
Arthralgias and Myalgias
Measured: every 4 months
Serum Calcium and Fasting Spot Urine Calcium/Creatinine Ratio
Measured: every 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Pegram
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Mark Pegram, Stanford University
- Investigators
- Eva Balint, Principal investigator, Stanford UniversityRobert W Carlson, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904423
- Sponsor's protocol ID
- IRB-15005
- Other IDs
- SU-09232008-1302, BRSADJ0014
- Status last verified
- Dec 2016
- First submitted
- 13 May 2009
- Last updated
- 14 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized, Double-blind, Controlled Study to Evaluate Efficacy and Safety of Vitamin D on Bone Mineral Density and Markers of Bone Resorption in Aromatase Inhibitor-induced Bone Loss in Women With Breast Cancer.
- ClinicalTrials.gov ID
- NCT00904423
- Acronym / sponsor ID
- IRB-15005
- Conditions
- Breast Cancer, Bone Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mark PegramUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Posted 14 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aromatase inhibitors are potent suppressors of breast cancer growth, but side effects include bone loss, fractures, arthralgias and myalgias. We hypothesize vitamin D administration might be beneficial in treating these symptoms and to protect bone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin D |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 3.1.1 All postmenopausal women with histology-confirmed invasive primary breast cancer, who have completed primary surgical or radiotherapy (XRT) with or without adjuvant chemotherapy and are candidates to receive adjuvant therapy with aromatase inhibitors will be screened for eligibility. Postmenopausal is defined as satisfying one or more of the following criteria: having had bilateral oophorectomy; aged more than 60 years; or aged 55-59 years with an intact uterus and amenorrheic for at least 12 months; or if amenorrheic for less than 12 months (after receiving hysterectomy, hormone therapy or chemotherapy).
- 3.1.2 At the time of study enrollment, participants will have completed primary surgical or XRT with or without adjuvant chemotherapy. Chemotherapy will be completed at least 28 days prior to enrollment.
- 3.1.4 Participants will be women between 18-85 years of age. Women and minorities will be actively recruited. Though breast cancer extremely rarely occurs in children and men, this study will only recruit adult females.
- 3.1.5 Participants will have a life expectancy of at least 5 years.
- 3.1.6 Participants will have Eastern Clinical Oncology Group (ECOG) performance status 0-2.
Key exclusion criteria (7 listed)
- 3.2.1 Medications affecting bone metabolism (bisphosphonates, anticonvulsants, chronic heparin therapy, chronic glucocorticoid use > 5 mg/day prednisone or equivalent, teriparatide).
- 3.2.2 Use of any investigational drug within past 90 days.
- 3.2.3 Metastatic breast cancer. High risk for osteoporosis/fractures (BMD < -2.0, history of non-traumatic fracture). Hyperparathyroidism Hypercalcemia Hypercalciuria (fasting spot urine calcium/creatinine ratio >0.20) History of renal stones Renal failure with creatinine over 2.0
- 3.2.4 Considering that vitamin D3 is produced by the human body, allergy to vitamin D3 is not expected to develop. Subjects with known history of allergic reaction to compounds used to manufacture capsules (rice powder) will be excluded form this study.
- 3.2.5 Recent history of excessive alcohol or drug use.
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 |
|---|---|---|
| Vitamin DAlso: Vital nutrientsup to 2400 mg; oral tablet | Drug | Vitamin D |
Primary outcome
Spine Bone Mineral Density T Score Change Over One Year
Time frame: 1 year
4 secondary outcomes
Change in Hip Bone Mineral Density (BMD) T-score
Time frame: one year
Bone Turnover Markers
Time frame: months 4 and 12
Arthralgias and Myalgias
Time frame: every 4 months
Serum Calcium and Fasting Spot Urine Calcium/Creatinine Ratio
Time frame: every 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Eva Balint principal investigator
Stanford University
Robert W Carlson principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin D in people with Breast Cancer and Bone Diseases, run by Mark Pegram 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Feb 2017. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Spine Bone Mineral Density T Score Change Over One Year (time frame: 1 year). 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 14 Feb 2017.