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

Purpose

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.

Condition	Intervention
Breast Neoplasms	Dietary Supplement: Vitamin D Dietary Supplement: Calcium carbonate Drug: Vitamin D Other: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Bone Density Breast Cancer Calcium Cancer Vitamin D

Drug Information available for: Calcium Gluconate Calcium carbonate Vitamin D Anastrozole

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

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). [ Time Frame: 6 months for randomized phase, 12 months for open-label phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 6 months for randomized phase, 12 months for open-label phase ] [ Designated as safety issue: No ]
To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	63
Study Start Date:	November 2005
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 400 units/day Dietary Supplement: Calcium carbonate 1000 mg/day Drug: Vitamin D 50,000 IU/week
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.	Dietary Supplement: Vitamin D 400 units/day Dietary Supplement: Calcium carbonate 1000 mg/day Other: Placebo Once per week.
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 400 units/day Dietary Supplement: Calcium carbonate 1000 mg/day

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263185

Locations

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

Sponsors and Collaborators

Washington University School of Medicine

AstraZeneca

Investigators

Principal Investigator:

Antonella Rastelli, M.D.

Washington University School of Medicine

More Information

Additional Information:

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00263185 History of Changes
Other Study ID Numbers:	05-0498 / 201012921
Study First Received:	December 6, 2005
Last Updated:	May 6, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Calcium Carbonate
Vitamin D
Ergocalciferols
Vitamins
Anastrozole
Antacids

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Bone Density Conservation Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013