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
18 Years
N/A
Female
Breast Neoplasms
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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).
Outcome Time Frame:
6 months for randomized phase, 12 months for open-label phase
Safety Issue:
No
Principal Investigator
Antonella Rastelli, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Washington University School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
05-0498 / 201012921
NCT ID:
NCT00263185
Start Date:
November 2005
Completion Date:
November 2009
Related Keywords:
- Breast Neoplasms
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Washington University | St. Louis, Missouri 63110 |
