| High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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No phase specified
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Supportive care
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Active
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Postmenopausal
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05-0498
NCT00263185
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Trial Description
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. Further Study Information 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.
Eligibility Criteria Inclusion Criteria - Women with a diagnosis of hormone receptor positive invasive breast cancer (Stage I-IIIB) or ductal carcinoma in situ (DCIS)
- 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 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 Contact Information
Trial Lead Organizations/Sponsors Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis AstraZeneca Pharmaceuticals LP
| Antonella Rastelli, M.D. | | Principal Investigator |
Trial Sites
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| U.S.A. |
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| Missouri |
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St. Louis |
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| | | | | | | | | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00263185
Information obtained from ClinicalTrials.gov on August 25, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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