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 30, 2015
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
Endpoint Classification: Efficacy Study
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:
  • Musculoskeletal symptom sub-scale on the Breast Cancer Prevention Trial symptom scale [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
  • Hand Grip Strength [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
  • PROMIS Physical Functioning Questionnaire [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medication adherence [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
  • Serum Hormones [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
  • Serum AI concentrations [ Time Frame: AUC for 0, 2, 4 hours post-dose, change from baseline to 6 months ] [ Designated as safety issue: No ]
  • Bone Mineral Density [ Time Frame: Change from screen to 6 months ] [ Designated as safety issue: No ]
  • Vitamin D binding protein genotype [ Time Frame: Baseline ] [ Designated as safety issue: No ]

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
Genders 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
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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
Last Updated: November 30, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Aromatase Inhibitors
Vitamin D
Bone Density Conservation Agents
Enzyme Inhibitors
Estrogen Antagonists
Growth Substances
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Steroid Synthesis Inhibitors processed this record on May 26, 2016