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Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01509079
Recruitment Status : Completed
First Posted : January 12, 2012
Results First Posted : November 29, 2016
Last Update Posted : June 18, 2019
University of Minnesota
University of Southern California
Information provided by (Responsible Party):
HealthPartners Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Muscle Pain Joint Pain Drug: Vitamin D3 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Phase 2 Study Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
Study Start Date : March 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

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

Secondary Outcome Measures :
  1. 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).

  2. 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

  3. Serum Estradiol Concentrations [ Time Frame: baseline and 6 months ]
  4. 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

  5. Whole Body Bone Mineral Density [ Time Frame: From Baseline and 6 months of D3 supplementation ]
    GLM Mean and standard deviation of Whole Body Bone Mineral Density (grams/cm2) of Trial Participants by Treatment Arm after controlling for bisphosphonate use

  6. Vitamin D Binding Protein Genotype [ Time Frame: Baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01509079

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

Publications of Results:
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Responsible Party: HealthPartners Institute Identifier: NCT01509079     History of Changes
Other Study ID Numbers: 03962-10C
First Posted: January 12, 2012    Key Record Dates
Results First Posted: November 29, 2016
Last Update Posted: June 18, 2019
Last Verified: October 2015
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Vitamin D
Aromatase Inhibitors
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists