Breast NeoplasmsEarly Phase 1NCT00263185
High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status
A Early Phase 1 study testing Vitamin D and Calcium carbonate in people with Breast Neoplasms, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Vitamin D supplementation reduces the symptoms of muscle stiffness and joint tenderness that some patients may develop after starting therapy with Anastrozole for breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Vitamin D and Calcium carbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Nov 2009
- Phase
- Early Phase 1
- 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
Who may be able to join
- Women with a diagnosis of hormone receptor positive invasive breast cancer (Stage I-IIIB) or ductal carcinoma in situ (DCIS)
- Postmenopausal status
- Completed at least 8 weeks of anastrozole as adjuvant therapy prior to study entry
- Completed systemic chemotherapy and radiation treatments when indicated
- Serum Calcium ≤ 10.3 mg/dL
- Patients with marginal 25 OH Vitamin D level (between 10 and 29 ng/ml) will be in the Randomized Group or Low 25 OH Vitamin D level (less than 10 ng/ml) will be in Observational Group
- 24-hour urine Calcium excretion ≤ 250 mg/g (calculated by dividing 24 hour calcium by 24 hour creatinine)
- A history of generalized musculoskeletal pain with or without localized regions or discomfort that has developed or worsened since starting adjuvant aromatase inhibitor therapy
Who cannot join
- Known metastatic disease
- History of kidney stones
- History of active primary hyperparathyroidism
- History of Paget's disease of the bone
- History of severe arthritis, rheumatoid arthritis, or severe neuropathy
- Normal 25 OH Vitamin D level (≥ 30 ng/ml)
- Medical or psychiatric condition which may preclude protocol compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo Controlled Trial of High Dose Vitamin D Therapy On Musculoskeletal Symptoms and Bone Mineral Density in Anastrozole-Treated Early Stage Breast Cancer Patients With Marginal Vitamin D Status
The purpose of this study is to determine whether Vitamin D supplementation reduces the symptoms of muscle stiffness and joint tenderness that some patients may develop after starting therapy with Anastrozole for breast cancer.
Read the detailed description
This is a pilot, double-blind, randomized, placebo-controlled study with the following aims:
- To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml).
- To evaluate the prevalence of vitamin D insufficiency/deficiency in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms versus those who are asymptomatic.
- To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms.
- To evaluate the effect of standard dose versus high dose Vitamin D replacement on bone density in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms.
- Conditions
- Breast Neoplasms
- Being tested
- Vitamin D, Calcium carbonate, Placebo
- Medical subject headings
- Breast Neoplasms
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 |
|---|---|---|
| Active Treatment Group | Experimental | Patients with baseline 25OH vitamin D level of 10-19 ng/ml.
* Calcium carbonate 1000 mg/day
* Vitamin D 400 units daily.
* Vitamin 50,000 IU/wk x 16 weeks and then once a month for a total of 6 months.
Patients with baseline 25OH vitamin D level of 20-29 ng/ml.
* Calcium carbonate 1000 mg/day
* Vitamin D 400 units daily.
* Vitamin 50,000 IU/wk x 8 weeks and then once a month for a total of 6 months. Receives: Dietary Supplement: Vitamin D; Dietary Supplement: Calcium carbonate; Drug: Vitamin D |
| Control Group | Placebo comparator | Patients with baseline 25OH vitamin D level of 10-19 ng/ml.
* Calcium carbonate 1000 mg/day
* Vitamin D 400 units daily.
* Placebo once per week x 16 weeks and then once a month for a total of 6 months.
Patients with baseline 25OH vitamin D level of 20-29 ng/ml.
* Calcium carbonate 1000 mg/day
* Vitamin D 400 units daily.
* Placebo once per week x 8 weeks and then once a month for a total of 6 months. Receives: Dietary Supplement: Vitamin D; Dietary Supplement: Calcium carbonate; Other: Placebo |
| Observational Group | Other | Patients with a baseline Vitamin D level below 10 ng/ml.
* Calcium carbonate 1000 mg/day
* Vitamin D 400 units daily. Receives: Dietary Supplement: Vitamin D; Dietary Supplement: Calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml).
Measured: 6 months for randomized phase, 12 months for open-label phase
Secondary outcomes (3)
To evaluate the prevalence of vitamin D insufficiency/deficiency in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms versus those who are asymptomatic.
Measured: 6 months for randomized phase, 12 months for open-label phase
To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms.
Measured: 6 months
To evaluate the effect of standard dose versus high dose Vitamin D replacement on bone density in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Antonella Rastelli, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263185
- Sponsor's protocol ID
- 05-0498 / 201012921
- Status last verified
- Sep 2014
- First submitted
- 6 Dec 2005
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo Controlled Trial of High Dose Vitamin D Therapy On Musculoskeletal Symptoms and Bone Mineral Density in Anastrozole-Treated Early Stage Breast Cancer Patients With Marginal Vitamin D Status
- ClinicalTrials.gov ID
- NCT00263185
- Acronym / sponsor ID
- 05-0498 / 201012921
- Conditions
- Breast Neoplasms
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Nov 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 7 Dec 2005 (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 purpose of this study is to determine whether Vitamin D supplementation reduces the symptoms of muscle stiffness and joint tenderness that some patients may develop after starting therapy with Anastrozole for breast cancer.
Detailed description
This is a pilot, double-blind, randomized, placebo-controlled study with the following aims:
- To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml).
- To evaluate the prevalence of vitamin D insufficiency/deficiency in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms versus those who are asymptomatic.
- To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms.
- To evaluate the effect of standard dose versus high dose Vitamin D replacement on bone density in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Group | Experimental | Dietary Supplement: Vitamin D, Dietary Supplement: Calcium carbonate, Drug: Vitamin DPatients with baseline 25OH vitamin D level of 10-19 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Vitamin 50,000 IU/wk x 16 weeks and then once a month for a total of 6 months. Patients with baseline 25OH vitamin D level of 20-29 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Vitamin 50,000 IU/wk x 8 weeks and then once a month for a total of 6 months. |
| Control Group | Placebo comparator | Dietary Supplement: Vitamin D, Dietary Supplement: Calcium carbonate, Other: PlaceboPatients with baseline 25OH vitamin D level of 10-19 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Placebo once per week x 16 weeks and then once a month for a total of 6 months. Patients with baseline 25OH vitamin D level of 20-29 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Placebo once per week x 8 weeks and then once a month for a total of 6 months. |
| Observational Group | Other | Dietary Supplement: Vitamin D, Dietary Supplement: Calcium carbonatePatients with a baseline Vitamin D level below 10 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women with a diagnosis of hormone receptor positive invasive breast cancer (Stage I-IIIB) or ductal carcinoma in situ (DCIS)
- Postmenopausal status
- Completed at least 8 weeks of anastrozole as adjuvant therapy prior to study entry
- Completed systemic chemotherapy and radiation treatments when indicated
- Serum Calcium ≤ 10.3 mg/dL
Key exclusion criteria (7 listed)
- Known metastatic disease
- History of kidney stones
- History of active primary hyperparathyroidism
- History of Paget's disease of the bone
- History of severe arthritis, rheumatoid arthritis, or severe neuropathy
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 D | Dietary supplement | Active Treatment Group, Control Group, Observational Group |
| Calcium carbonate | Dietary supplement | Active Treatment Group, Control Group, Observational Group |
| Vitamin D | Drug | Active Treatment Group |
| Placebo | Other | Control Group |
Primary outcome
To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml).
Time frame: 6 months for randomized phase, 12 months for open-label phase
3 secondary outcomes
To evaluate the prevalence of vitamin D insufficiency/deficiency in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms versus those who are asymptomatic.
Time frame: 6 months for randomized phase, 12 months for open-label phase
To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms.
Time frame: 6 months
To evaluate the effect of standard dose versus high dose Vitamin D replacement on bone density in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms.
Time frame: 6 months
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 22 Sep 2014.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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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.
Antonella Rastelli, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vitamin D and Calcium carbonate in people with Breast Neoplasms, run by Washington University School of Medicine 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 8 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: finished, as of the sponsor's last update on 22 Sep 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml). (time frame: 6 months for randomized phase, 12 months for open-label phase). 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 22 Sep 2014.