NCT00416715

Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer

A Pilot Study of Vitamin D Deficiency and Myalgias, Arthralgias and/or Joint Stiffness Associated With Letrozole (Femara® )

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying vitamin D deficiency, muscle pain, joint pain, and joint stiffness in postmenopausal women receiving letrozole for stage I-III breast cancer. Learning about vitamin D deficiency and muscle pain, joint pain, and joint stiffness in patients receiving letrozole for breast cancer may help doctors plan treatment and may help patients live more comfortably

Detailed description

PRIMARY OBJECTIVES: I. To assess the rate of vitamin D deficiency in breast cancer patients who experience myalgias, arthralgias and/or joint stiffness following initiation of adjuvant letrozole treatment. SECONDARY OBJECTIVES: I. To determine if there is a correlation between letrozole serum levels and the development of myalgias, arthralgias and/or joint stiffness. II. To assess if vitamin D supplementation may alleviate myalgias, arthralgias and/or joint stiffness associated with letrozole in those subjects with vitamin D deficiency. OUTLINE: Patients receive letrozole orally (PO) once daily (QD). Patients, who experience muscle pain, joint pain, or joint stiffness that requires an intervention and who are found to be vitamin D deficient, also receive calcium PO and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.

Conditions

• Arthralgia
• Musculoskeletal Complications
• Pain
• Recurrent Breast Cancer
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer

Interventions

Type	Name	Description
DRUG	letrozole	Given PO
DIETARY_SUPPLEMENT	calcium carbonate	Given PO
OTHER	laboratory biomarker analysis	Optional correlative studies
DIETARY_SUPPLEMENT	calcium citrate	Given PO
DIETARY_SUPPLEMENT	calcium glucarate	Given PO
DRUG	calcium gluconate	Given PO
DIETARY_SUPPLEMENT	cholecalciferol	Given PO
PROCEDURE	assessment of therapy complications	Ancillary studies
PROCEDURE	musculoskeletal complications management/prevention	Correlative studies

Timeline

• Start date: 2006-10-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2006-12-28
• Last updated: 2017-07-11
• Results posted: 2017-07-11

Locations

1 site across 1 country: United States