NCT01509079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 29, 2016

Completed
Last Updated

June 18, 2019

Status Verified

October 1, 2015

Enrollment Period

2.6 years

First QC Date

December 12, 2011

Results QC Date

August 15, 2016

Last Update Submit

May 28, 2019

Conditions

Muscle PainJoint Pain

Outcome Measures

Primary Outcomes (2)

  • 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

  • Change in Hand Grip Strength

    baseline to 6 months

Secondary Outcomes (6)

  • Change in PROMIS Physical Functioning Questionnaire

    baseline to 6 months

  • Average Percent Adherence to Vitamin D Interventio

    average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months

  • Serum Estradiol Concentrations

    baseline and 6 months

  • Change in Steady State Concentrations of Serum Anastrazole and Letrozole

    baseline to 6 months

  • Whole Body Bone Mineral Density

    From Baseline and 6 months of D3 supplementation

  • +1 more secondary outcomes

Study Arms (2)

Vitamin D3 4000 IU

EXPERIMENTAL
Drug: Vitamin D3

Vitamin D3 600 IU

ACTIVE COMPARATOR
Drug: Vitamin D3

Interventions

Vitamin D3DRUG

Cholecalciferol capsule, 4000IU, daily for 6 months

Vitamin D3 4000 IU

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Park Nicollet Frauenshuh Cancer Center

Minneapolis, Minnesota, 55416, United States

Location

Related Publications (1)

  • 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: 10.1007/s10549-016-3710-6. Epub 2016 Feb 11.

    PMID: 26868123RESULT

MeSH Terms

Conditions

MyalgiaArthralgia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsJoint Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Dr. Alice Shapiro
Organization
HealthPartnersInstitute
shapia@parknicollet.com
952-993-1704

Study Officials

  • Alice C. Shapiro, PhD RD

    Park Nicollet Health Services

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2011

First Posted

January 12, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2014

Study Completion

March 1, 2015

Last Updated

June 18, 2019

Results First Posted

November 29, 2016

Record last verified: 2015-10

Locations

US(1)