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Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors

This study has been completed.
University of Minnesota - Clinical and Translational Science Institute
University of Southern California
Information provided by (Responsible Party):
HealthPartners Institute Identifier:
First received: December 12, 2011
Last updated: November 10, 2016
Last verified: October 2015
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.

Condition Intervention Phase
Muscle Pain
Joint Pain
Drug: Vitamin D3
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Phase 2 Study Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors

Resource links provided by NLM:

Further study details as provided by HealthPartners Institute:

Primary Outcome Measures:
  • Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale [ Time Frame: baseline to 6 months ]
    The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia

  • Change in Hand Grip Strength [ Time Frame: baseline to 6 months ]

Secondary Outcome Measures:
  • Change in PROMIS Physical Functioning Questionnaire [ Time Frame: baseline to 6 months ]
    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).

  • Average Percent Adherence to Vitamin D Interventio [ Time Frame: average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months ]
    adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months

  • Serum Estradiol Concentrations [ Time Frame: baseline and 6 months ]
  • Change in Steady State Concentrations of Serum Anastrazole and Letrozole [ Time Frame: baseline to 6 months ]
    Difference in steady state concentrations in plasma from baseline to 6 months

  • Bone Mineral Density [ Time Frame: Change from screen to 6 months ]
  • Vitamin D Binding Protein Genotype [ Time Frame: Baseline ]

Enrollment: 116
Study Start Date: March 2012
Study Completion Date: March 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D3 4000 IU Drug: Vitamin D3
Cholecalciferol capsule, 4000IU, daily for 6 months
Active Comparator: Vitamin D3 600 IU Drug: Vitamin D3
cholecalciferol capsule, 600 IU, daily for 6 months

Detailed Description:
This project will determine the efficacy of vitamin D3 supplements for reducing side effects of treatment with aromatase inhibitors in women with a history of breast cancer that have no evidence of current disease. The aromatase inhibitors (AI) have become a critical component of adjuvant therapy for this population, but they cause bone pain, joint pain, joint stiffness, and muscle weakness in approximately 40% of patients. These symptoms, referred to as aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), decrease quality of life and medication adherence. Identifying effective ways to decrease these symptoms may allow for longer and more adherent medication use and thus may improve disease-free survival. We hypothesize that vitamin D3 may decrease symptoms associated with the use of aromatase inhibitors.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01509079

United States, Minnesota
Park Nicollet Frauenshuh Cancer Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
HealthPartners Institute
University of Minnesota - Clinical and Translational Science Institute
University of Southern California
Principal Investigator: Alice C. Shapiro, PhD RD Park Nicollet Health Services
  More Information

Responsible Party: HealthPartners Institute Identifier: NCT01509079     History of Changes
Other Study ID Numbers: 03962-10C
Study First Received: December 12, 2011
Results First Received: August 15, 2016
Last Updated: November 10, 2016

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Pain
Neuromuscular Diseases
Vitamin D
Aromatase Inhibitors
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on March 28, 2017