Clinical trial · Interventional
High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status
A Double-Blind, Randomized, Placebo Controlled Trial of High Dose Vitamin D Therapy On Musculoskeletal Symptoms and Bone Mineral Density in Anastrozole-Treated Early Stage Breast Cancer Patients With Marginal Vitamin D Status
NCT00263185CI-TRIAL-00015673completedEarly Phase 1ClinicalTrials.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)
The purpose of this study is to determine whether Vitamin D supplementation reduces the symptoms of muscle stiffness and joint tenderness that some patients may develop after starting therapy with Anastrozole for breast cancer.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcium carbonate | Dietary Supplement | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Vitamin D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Active Treatment Group
- description
- Patients with baseline 25OH vitamin D level of 10-19 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Vitamin 50,000 IU/wk x 16 weeks and then once a month for a total of 6 months. Patients with baseline 25OH vitamin D level of 20-29 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Vitamin 50,000 IU/wk x 8 weeks and then once a month for a total of 6 months.
- interventionNames
- Dietary Supplement: Vitamin D
- Dietary Supplement: Calcium carbonate
- Drug: Vitamin D
- type
- PLACEBO_COMPARATOR
- label
- Control Group
- description
- Patients with baseline 25OH vitamin D level of 10-19 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Placebo once per week x 16 weeks and then once a month for a total of 6 months. Patients with baseline 25OH vitamin D level of 20-29 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Placebo once per week x 8 weeks and then once a month for a total of 6 months.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Women with a diagnosis of hormone receptor positive invasive breast cancer (Stage I-IIIB) or ductal carcinoma in situ (DCIS) * Postmenopausal status * Completed at least 8 weeks of anastrozole as adjuvant therapy prior to study entry * Completed systemic chemotherapy and radiation treatments when indicated * Serum Calcium ≤ 10.3 mg/dL * Patients with marginal 25 OH Vitamin D level (between 10 and 29 ng/ml) will be in the Randomized Group or Low 25 OH Vitamin D level (less than 10 ng/ml) will be in Observational Group * 24-hour urine Calcium excretion ≤ 250 mg/g (calculated by dividing 24 hour calcium by 24 hour creatinine) * A history of generalized musculoskeletal pain with or without localized regions or discomfort that has developed or worsened since starting adjuvant aromatase inhibitor therapy Exclusion Criteria * Known metastatic disease * History of kidney stones * History of active primary hyperparathyroidism * History of Paget's disease of the bone * History of severe arthritis, rheumatoid arthritis, or severe neuropathy * Normal 25 OH Vitamin D level (≥ 30 ng/ml) * Medical or psychiatric condition which may preclude protocol compliance
References
Publications (0)
Data not yet available
No reference posted for this study.