High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status
NCT ID: NCT00263185
Last Updated: 2014-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
63 participants
INTERVENTIONAL
2005-11-30
2009-11-30
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Active Treatment Group
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.
Vitamin D
Calcium carbonate
Vitamin D
Control Group
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.
Vitamin D
Calcium carbonate
Placebo
Observational Group
Patients with a baseline Vitamin D level below 10 ng/ml.
* Calcium carbonate 1000 mg/day
* Vitamin D 400 units daily.
Vitamin D
Calcium carbonate
Interventions
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Vitamin D
Calcium carbonate
Vitamin D
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Antonella Rastelli, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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05-0498 / 201012921
Identifier Type: -
Identifier Source: org_study_id
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