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® )
Sponsor: National Cancer Institute (NCI)
This PHASE2 trial investigates Arthralgia and Musculoskeletal Complications and is currently completed. National Cancer Institute (NCI) leads this study, which shows 8 recorded versions since 2006 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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.
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.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
▶ Show 3 earlier versions
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Aug 2017 — Jun 2018 [monthly]
Completed PHASE2
-
Feb 2017 — Aug 2017 [monthly]
Completed PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
Oct 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Cancer Institute (NCI)
- University of Washington
For direct contact, visit the study record on ClinicalTrials.gov .