Clinical trial · Interventional
Vitamin D and Calcium Supplementation in Breast Cancer
Effect of Vitamin D and Calcium Supplementation on Letrozole-induced Musculoskeletal Side Effects in Breast Cancer Egyptian Patients
NCT05523609CI-TRIAL-00071888unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims at assessing the vitamin Dstatus in breast cancer patients who receive letrozole for more than two months and to evaluate effects of vitamin D3 and calcium supplementation on arthalgia caused by letrozole on these patients.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole 2.5mg | Drug | Letrozole | ALIAS |
| Letrozole + vitamin D3 and calcium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Control Group
- description
- 20 patients will receive Letrozole only for 12 weeks.
- interventionNames
- Drug: Letrozole 2.5mg
- type
- EXPERIMENTAL
- label
- VitD/Ca group
- description
- 20 patients will receive Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks.
- interventionNames
- Drug: Letrozole + vitamin D3 and calcium
Primary outcomes (1)
- measure
- Osteocalcin level
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed breast cancer patients. * Postmenopausal hormone receptor positive. * Patients receiving letrozole for more than two months * Gender: Female. * Age: ≥ 50 years old. Exclusion Criteria: * Patients with bone metastasis. * History of renal stones. * Serum calcium \>11mg/L. * Patients with renal insufficiency. * Patients taking steroid hormone replacement therapy. * Second Malignancy.
References
Publications (0)
Data not yet available
No reference posted for this study.