This study will look at the effect of 2 treatment regimens that contain vitamin D in a six-month treatment trial of patients with PHPT who are vitamin D deficient. Patients will be assigned randomly to one of 2 regimens, and will be followed with tests of their blood, urine and bones. This study should provide important information on the effect of vitamin D therapy in patients with PHPT. In addition, data from this study will guide physicians as to how best to treat their patients who have PHPT and vitamin D deficiency.
Primary hyperparathyroidism (PHPT) is a common disease in which the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. In primary hyperparathyroidism, high levels of PTH remove too much calcium from bones and deposit the excess calcium in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened by the excess calcium loss which weakens the structure of the bones. Many patients with primary hyperparathyroidism also have low vitamin D (25OHD) levels which is thought to further impair bone health. Recent medical guidelines recommend treating patients with primary hyperparathyroidism who have low vitamin D levels with oral vitamin D but the optimal vitamin D dose and rate of repletion is unclear. It is, therefore, important to determine if replenishing Vitamin D will improve bone health in primary hyperparathyroidism, and if so, to assess the impact of the rate of vitamin D repletion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
9
Columbia University Medical Center
New York, New York, United States
Serum Parathyroid Hormone (PTH) Level
This is designed to measure how many participants will achieve PTH \> 65 pg/mL.
Time frame: 6 months
Areal Bone Mineral Density of the Lumbar Spine
Measured by dual-energy x-ray absorptiometry (DEXA) scan
Time frame: 6 months
Trabecular Bone Density at the Forearm
Measured by high resolution peripheral quantitative computed tomography
Time frame: 6 months
Change in Urinary Calcium Level
This is designed to measure how the study treatment will affect urinary calcium level over time.
Time frame: 1 month, 3 months, 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.