Phase 2
N=160
Vitamin D3 for Aromatase Inhibitor Induced Arthralgias
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00867217 ↗Enrolled (actual)
160
Serious AEs
3.8%
Results posted
Feb 2018
Primary outcome: Primary: Number of Participants With Worsening of Musculoskeletal Symptoms (MS) — 23; 18; 24; 18 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- High Dose Vitamin D (Dietary_supplement); Placebo (Dietary_supplement); Standard Dose Vitamin D3 (Dietary_supplement); Letrozole 2.5mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Qamar Khan
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Worsening of Musculoskeletal Symptoms (MS) |
23; 18; 24; 18; 3; 0 | — |
Summary
The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.
Eligibility Criteria
Inclusion Criteria
- Post-menopausal women newly diagnosed with early stage breast cancer, who would be treated with an aromatase inhibitor
- Serum 25OHD levels < 40 ng/ml
Exclusion Criteria
- Severe or debilitating musculoskeletal pain
- Known metastatic disease
- History of renal stones
- History of hypercalcemia or hyperthyroidism
- Currently receiving adjuvant or neoadjuvant chemotherapy
- Currently receiving other investigational agents
Data sourced from ClinicalTrials.gov (NCT00867217). 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.