Phase 2
N=116
Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
Muscle Pain · Joint Pain
Bottom Line
View on ClinicalTrials.gov: NCT01509079 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale — -0.2; -0.5 units on a scale — p=0.38
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vitamin D3 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- HealthPartners Institute
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale |
-0.2; -0.5 | 0.38 |
| PRIMARY Change in Hand Grip Strength |
1.8; 1.0 | — |
| SECONDARY Change in PROMIS Physical Functioning Questionnaire |
0.6; 1.7 | — |
| SECONDARY Average Percent Adherence to Vitamin D Interventio |
95; 95 | — |
| SECONDARY Serum Estradiol Concentrations |
2.83; 2.77; 2.94; 3.0 | — |
| SECONDARY Change in Steady State Concentrations of Serum Anastrazole and Letrozole |
-1.31; 2.4; 2.16; -0.83 | — |
| SECONDARY Whole Body Bone Mineral Density |
1.1; 1.12 | — |
| SECONDARY Vitamin D Binding Protein Genotype |
— | — |
Summary
The Purpose of this study is to determine whether vitamin D3 supplements will decrease the muscle and bone pain that are reported by women who take Aromatase Inhibitors.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Women with a history of stage I-IIIa invasive breast cancer
- History of hormone-receptor positive cancer (either ER + or PR + or both)
- Are prescribed and are taking anastrozole, letrozole or exemestane for at least one month and have at least 7 months of AI treatment remaining
- Are experiencing AIMSS
Exclusion Criteria
- Unable to read or understand English
- History of psychiatric disability affecting informed consent or compliance with drug intake
- Malabsorption syndrome or inability to take oral medication
- Has less than 7 months of AI therapy remaining
Data sourced from ClinicalTrials.gov (NCT01509079). 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.