Efficacy and safety of recombinant human parathyroid hormone (1–84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase.

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Efficacy and safety of recombinant human parathyroid hormone (1–84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study Dr Michael Mannstadt, MD, Bart L Clarke, MD, Tamara Vokes, MD, Prof Maria Luisa Brandi, MD, Lakshminarayan Ranganath, MD, Prof William D Fraser, MD, Peter Lakatos, MD, Laszlo Bajnok, MD, Roger Garceau, MD, Prof Leif Mosekilde, MD, Hjalmar Lagast, MD, Prof Dolores Shoback, MD, Prof John P Bilezikian, MD The Lancet Diabetes & Endocrinology Volume 1, Issue 4, Pages 275-283 (December 2013) DOI: 10.1016/S2213-8587(13)70106-2 Copyright © 2013 Elsevier Ltd Terms and Conditions

Figure 1 Trial profile rhPTH(1–84)=recombinant human parathyroid hormone 1–84. *Due to hypertension (n=1), stroke (n=1), and several events (n=1, including injection site erythema, arthralgia, asthenia, blepharospasm, decreased appetite, depression, headache, nausea, pain in extremity, and hypercalcaemia). The Lancet Diabetes & Endocrinology 2013 1, 275-283DOI: (10.1016/S2213-8587(13)70106-2) Copyright © 2013 Elsevier Ltd Terms and Conditions

Figure 2 Achievement of primary outcome and independence from active vitamin D and reduction in oral calcium during treatment period, according to patient diary data (A) Proportion of patients achieving the criteria for the primary endpoint throughout the 24 week treatment period. (B) Proportion of patients who were able to stop taking active vitamin D and to reduce their dose of oral calcium dose to ≤500 mg per day throughout the 24 week treatment period. rhPTH(1–84)=recombinant human parathyroid hormone 1–84. The Lancet Diabetes & Endocrinology 2013 1, 275-283DOI: (10.1016/S2213-8587(13)70106-2) Copyright © 2013 Elsevier Ltd Terms and Conditions

Figure 3 Changes in calcium and active vitamin D doses throughout treatment period, by treatment group Mean oral calcium dose (A) and mean active vitamin D dose (B) in the placebo group and rhPTH(1–84) group throughout the 24 week treatment period. Error bars show SD. rhPTH(1–84)=recombinant human parathyroid hormone 1–84. From weeks 3–24, each mean measurement of calcium dose and active vitamin D dose differed significantly between groups (all p<0·005). The Lancet Diabetes & Endocrinology 2013 1, 275-283DOI: (10.1016/S2213-8587(13)70106-2) Copyright © 2013 Elsevier Ltd Terms and Conditions

Figure 4 Changes in albumin-corrected total serum calcium concentrations and 24 h urine calcium excretion throughout treatment period, by treatment group Mean albumin-corrected serum calcium concentration and mean 24 hr urinary calcium excretion in the placebo group (A) and rhPTH(1–84) group (B) throughout the 24 week treatment period. Error bars show SD. Every measurement of serum calcium from week 1 to week 16 differed significantly between treatment groups (p=0·018). Each measurement of urine calcium excretion from week 3 to week 8 differed significantly between groups (p=0·015). rhPTH(1–84)=recombinant human parathyroid hormone 1–84. The Lancet Diabetes & Endocrinology 2013 1, 275-283DOI: (10.1016/S2213-8587(13)70106-2) Copyright © 2013 Elsevier Ltd Terms and Conditions