NATPARA Phase 3 Clinical Trial Results
The majority of NATPARA patients maintained serum calcium at lower doses of calcium and active vitamin D (P<0.001)1,a
55%
(46/84) of patients using NATPARA were able to meet the primary endpoint at the end of treatment (Week 24), vs 3% (1/40) of patients on placebo (P<0.001) N=124
≥50%
reduction from baseline oral calcium
achieved by 69% of NATPARA patients, vs 7.5% for placebo1
+
≥50%
reduction from baseline active vitamin D dose
achieved by 87% of NATPARA patients, vs 45% for placebo1
+
Normalized or maintained
albumin-corrected total serum calcium level (7.5–10.6 mg/dL)a
achieved by 87% of NATPARA patients, vs 87% for placebo1
There were no differences in the proportion of patients with a serum calcium level between 7.5 and 10.6 mg/dL at the end of treatment between subjects randomized to NATPARA (86.9%) and placebo (87.5%).1
Study details: A 24-week, randomized, multinational, double-blind, placebo-controlled phase 3 trial evaluated the efficacy and safety of NATPARA in 124 adults with hypoparathyroidism after an optimization period of up to 16 weeks.1 View additional study details.
42%
NATPARA helped 42% of patients eliminate active vitamin D and reduce oral calcium to 500 mg or less per day1
42% (35/84) of patients were taking ≤500 mg of calcium daily and no vitamin D at the end of treatment (Week 24), vs 3% (1/40) of patients on placebo (P<0.001)
52%
NATPARA demonstrated a 52% reduction in oral calcium1
Patients on NATPARA (n=84) experienced a 52% reduction in their dose of calcium from baseline compared with a 7% increase for patients on placebo (n=40) (P<0.001)
Reference: 1. NATPARA [package insert]. Shire Pharmaceuticals, Inc.