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NATPARA Phase 3 Study Design

NATPARA was studied in a 24-week, randomized, double-blind, placebo-controlled trial in 124 adults with hypoparathyroidism1

Study design

OPTIMIZATION

Run-in
2-16 WEEKS

Calcium supplements and active vitamin D doses were adjusted to target an albumin-corrected serum calcium concentration between 8.0 and 9.0 mg/dL, and 25-hydroxyvitamin D was replaced in patients with insufficient stores.

BASELINE

Randomization

Patients were randomized to either 50 mcg of NATPARA (n=84) or placebo (n=40).

At randomization, active forms of vitamin D were reduced by 50%.

TREATMENT
NATPARA or Placebo

Titration
12 WEEKS

NATPARA was increased by 25 mcg increments every 4 weeks up to a maximum of 100 mcg, as indicated for patients who could not achieve independence from active vitamin D and who could not reduce oral calcium to 500 mcg or less per day.

Maintenance
12 WEEKS

The daily dose of NATPARA established during titration could be reduced, but not increased, in this phase2.

Doses of co-administered active forms of vitamin D and calcium were adjusted to maintain albumin-corrected serum calcium within a desired target range (8.0-9.0 mg/dL) in both arms.

Study population1 (NATPARA and Placebo Combined N=124 Patients)

Demographics

Mean Age

47 (range of 19 to 74 years)

Gender

79% female, 21% male

Race

96% White

Duration of hypoparathyroidism (mean)

15 years

Etiology

Post-surgical

71%

Idiopathic

25%

DiGeorge syndrome

3%

Autoimmune

1%

Renal impairment

Mild

45%

Moderate

10%

At baseline after optimization with oral calcium and active vitamin D

Daily oral calcium (median)

2000 (1250, 3000) mg

Daily oral vitamin D (median)

0.75 (0.5, 1) mcg calcitrol equivalent

Albumin-correct serum calcium (mean)

8.6 mg/dL

Representation of how study participants may have taken oral calcium and active vitamin D throughout the day

Learn About Dosing & Titration

References: 1. NATPARA [package insert]. Shire-NPS Pharmaceuticals, Inc. 2. Mannstadt M, Clarke BL, Vokes T, et al. Efficacy and safety of recombinant human parathyroid hormone (1–84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study. Lancet Diabetes Endocrinol. 2013;1(4):275-283. 3. National Institutes of Health. Calcium fact sheet for consumers. https://ods.od.nih.gov/factsheets/Calcium-Consumer/. Updated November 17, 2016. Accessed March 28, 2017.

NATPARA® is a registered trademark of Shire-NPS Pharmaceuticals, Inc.

OnePath® is a registered trademark of Shire or its affiliates.

Q-Cliq is a trademark of Shire-NPS Pharmaceuticals, Inc.