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

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Calcium carbonate
Vitamin D
Placebo
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Active Treatment Group

Control Group

Observational Group

Arm 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.

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.

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

Outcomes

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).

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.
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.

Full Information

First Posted
December 6, 2005
Last Updated
September 18, 2014
Sponsor
Washington University School of Medicine
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00263185
Brief Title
High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Observational Group
Arm Type
Other
Arm Description
Patients with a baseline Vitamin D level below 10 ng/ml. Calcium carbonate 1000 mg/day Vitamin D 400 units daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium carbonate
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonella Rastelli, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

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

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