Phase 2
Completed N=100
Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer
Arthralgia · Musculoskeletal Complications · Postoperative Pain · Recurrent Breast Cancer
Source: ClinicalTrials.gov NCT00416715 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness — 12; 1 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness |
12; 1 | — |
| SECONDARY Letrozole Serum Levels Before and After Vitamin D Repletion |
85; 70 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have a histologically confirmed diagnosis of Stage I, II or III breast carcinoma
- Patients must be prescribed letrozole for adjuvant breast cancer treatment
- Prior adjuvant tamoxifen is permitted
- Patients must be postmenopausal; for study purposes, postmenopausal is defined as: a prior documented bilateral oophorectomy, or a history of at least 12 months without spontaneous menstrual bleeding, or have a persistently postmenopausal estradiol in the past 6 months without menses, and clinically in menopause at the judgment of the treating physician, or age 60 or older with a prior hysterectomy without oophorectomy, or age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented FSH level demonstrating confirmatory elevation in the postmenopausal range for the lab
Exclusion Criteria
- Diagnosis of Stage IV breast carcinoma
- Pre-existing myalgias, arthralgias and/or joint stiffness >= Grade 1, as defined using CTEP CTC identified during baseline physical exam
- Inability to understand or cooperate with study procedures
- Receipt of investigational drug within 30 days before study entry
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- Unwillingness to give informed consent
- Unwillingness to participate or inability to comply with the protocol for the duration of the study
- Patients with serum calcium >= 14 mg/dL
- Patients with renal dysfunction defined as glomerular filtration rate <10ml/min calculated using Cockroft-Gault equation
Data sourced from ClinicalTrials.gov (NCT00416715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.