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

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: NCT01809171
Recruitment Status : Terminated (Inclusion problems)
First Posted : March 12, 2013
Last Update Posted : October 21, 2015
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Musculoskeletal Disease Drug: Vitamin D3 Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-controlled Trial With Vitamin D to Prevent Worsening/Relieve Aromatase Inhibitor-induced Musculoskeletal Symptoms in Breast Cancer Patients
Study Start Date : October 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: vitamin D3
1000 mg Ca2+/800IU vitamin D3 daily + 25 000IU vitamin D3 weekly during 6 months
Drug: Vitamin D3

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

Primary Outcome Measures :
  1. Change from baseline in musculoskeletal pain and 250HD levels [ Time Frame: 3 monthly during one year ]

Secondary Outcome Measures :
  1. Change from baseline in bone parameters, estrogen and IGF-I levels and fluid accumulation and tendon pathologies, as seen on MRI [ Time Frame: 3 monthly during 1 year, MRI at baseline and 3 months ]

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:

  • 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

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): NCT01809171

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University Hospitals Leuven
Leuven, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01809171    
Other Study ID Numbers: s55283
2013-001064-27 ( EudraCT Number )
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Breast Neoplasms
Musculoskeletal Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents