Clinical trial · Interventional
Placebo-controlled Trial With Vitamin D to Prevent Worsening/Relieve Aromatase Inhibitor-induced Musculoskeletal Symptoms in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inclusion problems
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Musculoskeletal Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Vitamin D3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- vitamin D3
- description
- 1000 mg Ca2+/800IU vitamin D3 daily + 25 000IU vitamin D3 weekly during 6 months
- interventionNames
- Drug: Vitamin D3
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 1000 mg Ca2+/ 800IU vitamin D3 daily + 25000IU placebo every week during 6 months
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Change from baseline in musculoskeletal pain and 250HD levels
- timeFrame
- 3 monthly during one year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRoberts 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 35005781