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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00263185
First received: December 6, 2005
Last updated: August 9, 2013
Last verified: August 2013
  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:


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 Dietary Supplement: Calcium carbonate Drug: Vitamin D
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 Dietary Supplement: Calcium carbonate Other: Placebo
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

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:
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: August 9, 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 April 17, 2014