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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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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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 UniversitySt. Louis, Missouri  63110