Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263185
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2005-12-06
Brief Title:
High Dose Vit D Musculoskeletal Symptoms Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ngml
To evaluate the prevalence of vitamin D insufficiencydeficiency 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
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 ngml
To evaluate the prevalence of vitamin D insufficiencydeficiency 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None