Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study

Michael Mannstadt; Bart L Clarke; Tamara Vokes; Maria Luisa Brandi; Lakshminarayan Ranganath; William D Fraser; Peter Lakatos; Laszlo Bajnok; Roger Garceau; Leif Mosekilde; Hjalmar Lagast; Dolores Shoback; John P Bilezikian

doi:10.1016/S2213-8587(13)70106-2

Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study

Michael Mannstadt, Bart L Clarke, Tamara Vokes, Maria Luisa Brandi, Lakshminarayan Ranganath, William D Fraser, Peter Lakatos, Laszlo Bajnok, Roger Garceau, Leif Mosekilde, Hjalmar Lagast, Dolores Shoback, John P Bilezikian

Research output: Contribution to journal › Article › peer-review

229 Citations (Scopus)

Abstract

Hypoparathyroidism results in impaired mineral homoeostasis, including hypocalcaemia and hyperphosphataemia. Treatment with high-dose oral calcium and active vitamin D does not provide adequate or consistent control of biochemical indices and can lead to serious long-term complications. We aimed to test the efficacy, safety, and tolerability of once-daily recombinant human parathyroid hormone 1-84 (rhPTH[1-84]) in adults with hypoparathyroidism.

Original language	English
Pages (from-to)	275-283
Number of pages	9
Journal	The Lancet Diabetes & Endocrinology
Volume	1
Issue number	4
Early online date	7 Oct 2013
DOIs	https://doi.org/10.1016/S2213-8587(13)70106-2
Publication status	Published - 1 Dec 2013

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10.1016/S2213-8587(13)70106-2

Cite this

Mannstadt, M., Clarke, B. L., Vokes, T., Brandi, M. L., Ranganath, L., Fraser, W. D., Lakatos, P., Bajnok, L., Garceau, R., Mosekilde, L., Lagast, H., Shoback, D., & Bilezikian, J. P. (2013). Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study. The Lancet Diabetes & Endocrinology, 1(4), 275-283. https://doi.org/10.1016/S2213-8587(13)70106-2

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abstract = "Hypoparathyroidism results in impaired mineral homoeostasis, including hypocalcaemia and hyperphosphataemia. Treatment with high-dose oral calcium and active vitamin D does not provide adequate or consistent control of biochemical indices and can lead to serious long-term complications. We aimed to test the efficacy, safety, and tolerability of once-daily recombinant human parathyroid hormone 1-84 (rhPTH[1-84]) in adults with hypoparathyroidism.",

author = "Michael Mannstadt and Clarke, {Bart L} and Tamara Vokes and Brandi, {Maria Luisa} and Lakshminarayan Ranganath and Fraser, {William D} and Peter Lakatos and Laszlo Bajnok and Roger Garceau and Leif Mosekilde and Hjalmar Lagast and Dolores Shoback and Bilezikian, {John P}",

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Mannstadt, M, Clarke, BL, Vokes, T, Brandi, ML, Ranganath, L, Fraser, WD, Lakatos, P, Bajnok, L, Garceau, R, Mosekilde, L, Lagast, H, Shoback, D & Bilezikian, JP 2013, 'Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study', The Lancet Diabetes & Endocrinology, vol. 1, no. 4, pp. 275-283. https://doi.org/10.1016/S2213-8587(13)70106-2

Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE) : a double-blind, placebo-controlled, randomised, phase 3 study. / Mannstadt, Michael; Clarke, Bart L; Vokes, Tamara et al.

In: The Lancet Diabetes & Endocrinology, Vol. 1, No. 4, 01.12.2013, p. 275-283.

Research output: Contribution to journal › Article › peer-review

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