Status:
COMPLETED
High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
AstraZeneca
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
Brief 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 Ana...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00263185
Start Date
November 1 2005
End Date
November 1 2009
Last Update
September 22 2014
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110