Participants
μg/d, hypoparathyroidism, idiopathic etiologies
HYPOPARATHYROIDISM
Eligible participants included men and nonpregnant women (≥18 years of age) with chronic hypoparathyroidism of postsurgical, autoimmune, genetic, or idiopathic etiologies for a duration of at least 26 weeks. Participants must have been treated with calcitriol ≥0.5 μg/d or alfacalcidol ≥1.0 μg/d in addition to elemental calcium ≥800 mg/d for at least 12 weeks before screening. Stable doses of conventional therapy (ie, active vitamin D and calcium) were required for at least 5 weeks before screening, not precluding occasional (≤2/week) pro re nata (PRN, as needed) doses of calcium and/or active vitamin D. To ensure safety for those who might be randomized to the placebo arm, participants were required to achieve an albumin‐adjusted or ionized serum calcium within the normal range or slightly below the normal range (albumin‐adjusted serum calcium 7.8–10.6 mg/dL [1.95–2.64 mmol/L] or ionized serum calcium 4.40–5.29 mg/dL [1.10–1.32 mmol/L]), 25(OH) vitamin D levels 20–80 ng/mL (49–200 nmol/L), and magnesium levels ≥1.3 mg/dL (0.53 mmol/L), as is currently the goal of conventional treatment.