High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status

The Washington University

Status and phase

Completed

Early Phase 1

Conditions

Breast Neoplasms

Treatments

Other: Placebo

Dietary Supplement: Calcium carbonate

Drug: Vitamin D

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00263185

05-0498 / 201012921

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

63 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

63 participants in 3 patient groups, including a placebo group

Active Treatment Group

Experimental group

Description:

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.

Treatment:

Drug: Vitamin D

Dietary Supplement: Calcium carbonate

Drug: Vitamin D

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Calcium carbonate

Other: Placebo

Observational Group

Other group

Description:

Patients with a baseline Vitamin D level below 10 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily.

Treatment:

Dietary Supplement: Calcium carbonate