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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Other: Placebo; Dietary supplement: Vitamin D; Drug: Vitamin D; Dietary supplement: Calcium carbonate

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 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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment Group; 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.	Dietary supplement: Vitamin D; Drug: Vitamin D; Dietary supplement: Calcium carbonate
Placebo Comparator: Control Group; 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.	Other: Placebo; Dietary supplement: Vitamin D; Dietary supplement: Calcium carbonate
Other: Observational Group; Patients with a baseline Vitamin D level below 10 ng/ml.; Calcium carbonate 1000 mg/day; Vitamin D 400 units daily.	Dietary supplement: Vitamin D; Dietary supplement: Calcium carbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	6 months for randomized phase, 12 months for open-label phase

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	6 months for randomized phase, 12 months for open-label phase
To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms.	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Antonella Rastelli, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: December 6, 2005
• First Submitted That Met QC Criteria: December 6, 2005
• First Posted (Estimate): December 7, 2005

Study Record Updates

• Last Update Posted (Estimate): September 22, 2014
• Last Update Submitted That Met QC Criteria: September 18, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Antacids; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols; Calcium Carbonate
• Other Study ID Numbers: 05-0498 / 201012921