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

Sponsors and Collaborators:	Washington University School of Medicine AstraZeneca
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00263185

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	Drug: Vitamin D Drug: Calcium carbonate Other: Vitamin D

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Calcium Cancer

Drug Information available for: Anastrozole Calcium gluconate Vitamin D Ergocalciferol Calcium carbonate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
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

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: 8 weeks ] [ 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: 8 weeks ] [ 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 ]

Estimated Enrollment:	60
Study Start Date:	November 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Active Treatment	Drug: Vitamin D Vitamin D 400 U/day for 8 weeks Drug: Calcium carbonate Calcium carbonate 1000 mg/day for 8 weeks
2: Placebo Comparator Placebo control	Drug: Calcium carbonate Calcium carbonate 1000 mg/day fo 8 weeks Drug: Vitamin D Vitamin D 400 U/Day for 8 weeks
3: No Intervention Observation	Other: Vitamin D Vitamin D 50,000 IU for 16 weeks

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

Contacts

Contact: Shohreh Jamalabadi-Majidi

314-362-2529

sjamalab@dom.wustl.edu

Locations

United States, Missouri
Washington University	Recruiting
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

Responsible Party:	Washington University ( Antonella Rastelli, M.D. )
Study ID Numbers:	05-0498
Study First Received:	December 6, 2005
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00263185
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Calcium, Dietary
Anastrozole
Vitamin D
Skin Diseases

Ergocalciferols
Breast Neoplasms
Calcium Carbonate
Breast Diseases

Additional relevant MeSH terms:

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

Neoplasms
Neoplasms by Site
Vitamins
Therapeutic Uses
Antacids
Micronutrients
Aromatase Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009