Placebo-controlled trial with vitamin D to prevent worsening/relieve aromatase inhibitor-induced musculoskeletal symptoms in breast cancer patients

Phase 1

• Conditions: aromatase inhibitor-induced musculoskeletal symptoms in postmenopausal breast cancer patients; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-001064-27-BE
• Lead Sponsor: niversity Hospitals Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-26
• Last Update Posted: 3 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

Caucasian vitamin D deficient (<30ng/ml) postmenopausal breast cancer patients treated with an aromatase inhibitor (for minimum 8 weeks) and experiencing musculoskeletal symptoms

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

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
Serum 25OHD levels < 10ng/ml

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate effect of high dose vitamin D supplementation on aromatase inhibitor-induced musculoskeletal symptoms (with questionnaire, grip strength and MRI).;Secondary Objective: Effect of high dose vitamin D supplementation on bone parameters and estrogen levels.<br>;Primary end point(s): Change from baseline in musculoskeletal pain <br>Change from baseline in 250HD levels <br>;Timepoint(s) of evaluation of this end point: baseline<br>3 months<br>6 months<br>9 months<br>12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change from baseline in bone parameters<br>Change from baseline in estrogen levels<br>Change from baseline in fluid accumulation and tendon abnormalities, as seen on MRI;Timepoint(s) of evaluation of this end point: baseline<br>3 months (MRI)<br>6 months<br>9 months<br>12 months