Joint Pain Clinical Trial
Official title:
Phase 2 Study Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
NCT number | NCT01509079 |
Other study ID # | 03962-10C |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2012 |
Est. completion date | March 2015 |
Verified date | October 2015 |
Source | HealthPartners Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 116 |
Est. completion date | March 2015 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Park Nicollet Frauenshuh Cancer Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
HealthPartners Institute | University of Minnesota - Clinical and Translational Science Institute, University of Southern California |
United States,
Shapiro AC, Adlis SA, Robien K, Kirstein MN, Liang S, Richter SA, Lerner RE. Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Breast Cancer Res Treat. 2016 Feb;155(3):501-12. doi: 10.100 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale | The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia | baseline to 6 months | |
Primary | Change in Hand Grip Strength | baseline to 6 months | ||
Secondary | Change in PROMIS Physical Functioning Questionnaire | PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst). | baseline to 6 months | |
Secondary | Average Percent Adherence to Vitamin D Interventio | adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months | average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months | |
Secondary | Serum Estradiol Concentrations | baseline and 6 months | ||
Secondary | Change in Steady State Concentrations of Serum Anastrazole and Letrozole | Difference in steady state concentrations in plasma from baseline to 6 months | baseline to 6 months | |
Secondary | Whole Body Bone Mineral Density | GLM Mean and standard deviation of Whole Body Bone Mineral Density (grams/cm2) of Trial Participants by Treatment Arm after controlling for bisphosphonate use | From Baseline and 6 months of D3 supplementation | |
Secondary | Vitamin D Binding Protein Genotype | Baseline |
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