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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

For the primary efficacy endpoint, patients had to fulfill all 3 components of a 3-part response criterion:

For the primary efficacy endpoint, patients had to fulfill all 3 components of a 3-part response criterion:

1

≥50%

reduction from baseline oral calcium

achieved by 69% of NATPARA patients, vs 7.5% for placebo1

+

+

3

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-NPS Pharmaceuticals, Inc.

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