CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
letrozole +8 moredrug
Likely dose
Letrozole dosage not specified in protocol; calcium and cholecalciferol (vitamin D) supplementation dosages not specifiedAI-extracted
Key inclusion· 4
  • ✓Histologically confirmed Stage I, II, or III breast carcinoma
  • ✓Prescribed letrozole for adjuvant breast cancer treatment
  • ✓Postmenopausal status, defined by bilateral oophorectomy, ≥12 months without menstrual bleeding, postmenopausal estradiol levels, age ≥60 with prior hysterectomy, or age <60 with prior hysterectomy and elevated FSH
  • ✓Prior adjuvant tamoxifen is permitted
Key exclusion· 6
  • ✕Stage IV breast carcinoma
  • ✕Pre-existing myalgias, arthralgias, and/or joint stiffness ≥ Grade 1 at baseline
  • ✕Serum calcium ≥14 mg/dL
  • ✕Renal dysfunction with glomerular filtration rate <10 mL/min by Cockroft-Gault equation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00416715
NCT00416715Phase 2Completed
CompareCT.gov

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

University of Washington·interventional·Posted Dec 28, 2006·Updated Jul 11, 2017

In Brief

A Phase 2 clinical trial evaluating letrozole, calcium carbonate, and 7 other interventions for Arthralgia and 8 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthralgia, 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
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 28, 2006
Enrollment StartOct 1, 2006
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 19.5 years ago

Interventions

letrozoledrug

Given PO

calcium carbonatedietary

Given PO

laboratory biomarker analysisother

Optional correlative studies

calcium citratedietary

Given PO

calcium glucaratedietary

Given PO

calcium gluconatedrug

Given PO

cholecalciferoldietary

Given PO

assessment of therapy complicationsprocedure

Ancillary studies

musculoskeletal complications management/preventionprocedure

Correlative studies