Placebo-controlled Trial With Vitamin D to Prevent Worsening/Relieve Aromatase Inhibitor-induced Musculoskeletal Symptoms in Breast Cancer Patients

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01809171

Enrollment

Registered

2013-03-12

Start date

2013-10-31

Completion date

2015-08-31

Last updated

2015-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Musculoskeletal Disease

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.

Interventions

DRUGVitamin D3

ampoule

DRUGPlacebo

ampoule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Change from baseline in musculoskeletal pain and 250HD levels	3 monthly during one year

Secondary

Measure	Time frame
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026