NCT01809171

Brief Summary

The third generation oral aromatase inhibitors (AIs) are increasingly being used in the management of estrogen receptor positive breast cancer. One of the issues related with administration of oral AIs is their side effects, particularly on the musculoskeletal system. Although the prevalence and importance of arthralgia and myalgia occurring in BC patients receiving adjuvant AIs are evident, the mechanisms clearly explaining these invalidating symptoms are unknown. In this project, we aim to unravel the interaction between vitamin D and musculoskeletal adverse events experienced by AI users. We will also evaluate how vitamin D supplementation affects AI-induced musculoskeletal symptoms in breast cancer patients, by means of a randomized placebo-controlled double blind clinical trial. We will assess changes in the musculoskeletal system by using magnetic resonance imaging of joints, hand grip strength and also monitor serum IGF-I and estrogen levels together with bone resorption and formation markers.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

March 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 21, 2015

Status Verified

October 1, 2015

Enrollment Period

1.8 years

First QC Date

March 8, 2013

Last Update Submit

October 20, 2015

Conditions

Breast CancerMusculoskeletal Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in musculoskeletal pain and 250HD levels

    3 monthly during one year

Secondary Outcomes (1)

  • Change from baseline in bone parameters, estrogen and IGF-I levels and fluid accumulation and tendon pathologies, as seen on MRI

    3 monthly during 1 year, MRI at baseline and 3 months

Study Arms (2)

vitamin D3

EXPERIMENTAL

1000 mg Ca2+/800IU vitamin D3 daily + 25 000IU vitamin D3 weekly during 6 months

Drug: Vitamin D3

Placebo

PLACEBO COMPARATOR

1000 mg Ca2+/ 800IU vitamin D3 daily + 25000IU placebo every week during 6 months

Drug: Placebo

Interventions

Vitamin D3DRUG

ampoule

vitamin D3
PlaceboDRUG

ampoule

Placebo

Eligibility Criteria

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

You may qualify if:

  • Postmenopausal status
  • Currently being treated with an AI in the adjuvant setting (minimum for 8 weeks)
  • AIMSS as determined by new or worsened musculoskeletal complaints following AI therapy
  • Vitamin D deficiency (\<30ng/ml)
  • Caucasian

You may not qualify if:

  • Hormone replacement therapy last 6 months
  • Current use or in the last 12 months of bisphosphonates
  • Tamoxifen use in last 6 months
  • History of kidney stones
  • History of hypercalcemia/hypercalciuria or hyperthyroidism
  • Paget's disease of the bone
  • Current use of Digitalis/digoxin or thiazide diuretics
  • Current use of vitamin D (or multivitamin) supplementation should be stopped

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Belgium

Location

Related Publications (1)

  • Roberts KE, Adsett IT, Rickett K, Conroy SM, Chatfield MD, Woodward NE. Systemic therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer. Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD013167. doi: 10.1002/14651858.CD013167.pub2.

    PMID: 35005781DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMusculoskeletal Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

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

Study Record Dates

First Submitted

March 8, 2013

First Posted

March 12, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 21, 2015

Record last verified: 2015-10

Locations

BE(1)