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A phase 2 trial exploring the effects of high-dose (10,000 IU/day) Vitamin D3 in breast cancer patients with bone metastases
Cancer, 11/25/09
Amir E et al. – This study aimed to assess the effect of high dose of vitamin D3 in patients with bone metastases from breast cancer. Daily doses of 10,000 IU vitamin D3 for 4 months appear safe in patients without comorbid conditions causing hypersensitivity to vitamin D. Treatment reduced inappropriately elevated parathyroid hormone levels, presumably caused by long-term bisphosphonate use. There did not appear to be a significant palliative benefit nor any significant change in bone resorption.
Methods- Patients with bone metastases treated with bisphosphonates enrolled into single-arm phase 2 study
- Received 10,000 IU of vitamin D3 and 1000 mg of calcium supplementation each day for 4 months
- Effect of treatment on palliation, bone resorption markers, calcium metabolism, and toxicity evaluated at baseline and monthly thereafter
- 40 patients enrolled
- No significant changes in bone resorption markers seen
- Despite no change in global pain scales, there was significant reduction in number of sites of pain
- Small but statistically significant increase in serum calcium seen, as was significant decrease in serum parathyroid hormone
- Treatment unmasked 2 cases of primary hyperparathyroidism, but not associated with direct toxicity
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