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Study · Randomized controlled trial · n = 124 · 2017

6 results

Effects of parathyroid hormone rhPTH(1-84) on phosphate homeostasis and vitamin D metabolism in hypoparathyroidism: REPLACE phase 3 study.

Clarke BL, Vokes TJ, Bilezikian JP, Shoback DM, Lagast H, Mannstadt M

Endocrine12 Oct 2016Cited by 44 (Europe PMC)

PMID27734257 (opens in a new tab)PMCIDPMC5225224 (opens in a new tab)DOI10.1007/s12020-016-1141-0 (opens in a new tab)PepBankPUB-27734257
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Summary

In hypoparathyroidism, inappropriately low levels of parathyroid hormone lead to unbalanced mineral homeostasis. The objective of this study was to determine the effect of recombinant human parathyroid hormone, rhPTH(1-84), on phosphate and vitamin D metabolite levels in patients with hypoparathyroidism. Following pretreatment optimization of calcium and vitamin D doses, 124 patients in a phase III, 24-week, randomized, double-blind, placebo-controlled study of adults with hypoparathyroidism received subcutaneous injections of placebo or rhPTH(1-84) (50 µg/day, titrated to 75 and then 100 µg/day, to permit reductions in oral calcium and active vitamin D doses while maintaining serum calcium within 2.0-2.2 mmol/L). Predefined endpoints related to phosphate homeostasis and vitamin D metabolism were analyzed. Serum phosphate levels decreased rapidly from the upper normal range and remained lower with rhPTH(1-84) (P < 0.001 vs. placebo). At week 24, serum calcium-phosphate product was lower with rhPTH(1-84) vs. placebo (P < 0.001). rhPTH(1-84) treatment resulted in significant reductions in oral calcium dose compared with placebo (P < 0.001) while maintaining serum calcium. After pretreatment optimization, baseline serum 25-hydroxyvitamin D (25[OH]D) and 1,25-dihydroxyvitamin D (1,25[OH]2D) levels were within the normal range in both groups. After 24 weeks, 1,25(OH)2D levels were unchanged in both treatment groups, despite significantly greater reductions in active vitamin D dose in the rhPTH(1-84) group. In hypoparathyroidism, rhPTH(1-84) reduces serum phosphate levels, improves calcium-phosphate product, and maintains 1,25(OH)2D and serum calcium in the normal range while allowing significant reductions in active vitamin D and oral calcium doses.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In hypoparathyroidism, PTH reduced serum phosphate versus placebo (P < 0.001).

    In plain wordsIn hypoparathyroidism, PTH reduced blood phosphate versus placebo.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    DecreaseSerum phosphate
    Study

    n = 124

    Comparator
    Placebo
    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    50 µg/day titrated to 75 and then 100 µg/day · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Serum phosphate levels decreased rapidly from the upper normal range and remained lower with rhPTH(1-84) (P < 0.001 vs. placebo).
    1 context sentence
    Summary · context
    Following pretreatment optimization of calcium and vitamin D doses, 124 patients in a phase III, 24-week, randomized, double-blind, placebo-controlled study of adults with hypoparathyroidism received subcutaneous injections of placebo or rhPTH(1-84)
  2. 02HumanRandomized controlled trialEfficacy outcome

    In hypoparathyroidism, PTH lowered calcium-phosphate product versus placebo at week 24 (P < 0.001).

    In plain wordsIn hypoparathyroidism, PTH lowered calcium-phosphate product versus placebo at week 24.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    DecreaseSerum calcium-phosphate product
    Study

    n = 124

    Comparator
    Placebo
    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    50 µg/day titrated to 75 and then 100 µg/day · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    At week 24, serum calcium-phosphate product was lower with rhPTH(1-84) vs. placebo (P < 0.001).
    1 context sentence
    Summary · context
    Following pretreatment optimization of calcium and vitamin D doses, 124 patients in a phase III, 24-week, randomized, double-blind, placebo-controlled study of adults with hypoparathyroidism received subcutaneous injections of placebo or rhPTH(1-84)
  3. 03HumanRandomized controlled trialEfficacy outcome

    In hypoparathyroidism, PTH reduced oral calcium dose versus placebo (P < 0.001).

    In plain wordsIn hypoparathyroidism, PTH reduced calcium supplement doses versus placebo.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    DecreaseOral calcium dose
    Study

    n = 124

    Comparator
    Placebo
    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    50 µg/day titrated to 75 and then 100 µg/day · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    rhPTH(1-84) treatment resulted in significant reductions in oral calcium dose compared with placebo (P < 0.001) while maintaining serum calcium.
    1 context sentence
    Summary · context
    Following pretreatment optimization of calcium and vitamin D doses, 124 patients in a phase III, 24-week, randomized, double-blind, placebo-controlled study of adults with hypoparathyroidism received subcutaneous injections of placebo or rhPTH(1-84)
  4. 04HumanRandomized controlled trialEfficacy outcome

    In hypoparathyroidism, active vitamin D dose reductions were significantly greater with PTH than placebo.

    In plain wordsIn hypoparathyroidism, PTH reduced active vitamin D doses more than placebo.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    DecreaseActive vitamin D dose
    Study

    n = 124

    Comparator
    Placebo
    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    50 µg/day titrated to 75 and then 100 µg/day · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    After 24 weeks, 1,25(OH)2D levels were unchanged in both treatment groups, despite significantly greater reductions in active vitamin D dose in the rhPTH(1-84) group.
    1 context sentence
    Summary · context
    Following pretreatment optimization of calcium and vitamin D doses, 124 patients in a phase III, 24-week, randomized, double-blind, placebo-controlled study of adults with hypoparathyroidism received subcutaneous injections of placebo or rhPTH(1-84)
  5. 05HumanNon-randomized trialEfficacy outcome

    In hypoparathyroidism, PTH maintained serum calcium despite reduced calcium supplementation.

    In plain wordsIn hypoparathyroidism, PTH maintained blood calcium despite reduced calcium supplementation.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    Direction not reportedSerum calcium maintenance
    Study

    n: not reported in source

    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    50 µg/day titrated to 75 and then 100 µg/day · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    rhPTH(1-84) treatment resulted in significant reductions in oral calcium dose compared with placebo (P < 0.001) while maintaining serum calcium.
    1 context sentence
    Summary · context
    Following pretreatment optimization of calcium and vitamin D doses, 124 patients in a phase III, 24-week, randomized, double-blind, placebo-controlled study of adults with hypoparathyroidism received subcutaneous injections of placebo or rhPTH(1-84)
  6. 06HumanNon-randomized trialEfficacy outcome

    In hypoparathyroidism, 1,25-dihydroxyvitamin D remained unchanged after 24 weeks in both PTH and placebo groups.

    In plain wordsIn hypoparathyroidism, active vitamin D levels remained unchanged after 24 weeks in both PTH and placebo groups.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    No significant change1,25-dihydroxyvitamin D
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    50 µg/day titrated to 75 and then 100 µg/day · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    After 24 weeks, 1,25(OH)2D levels were unchanged in both treatment groups, despite significantly greater reductions in active vitamin D dose in the rhPTH(1-84) group.
    1 context sentence
    Summary · context
    Following pretreatment optimization of calcium and vitamin D doses, 124 patients in a phase III, 24-week, randomized, double-blind, placebo-controlled study of adults with hypoparathyroidism received subcutaneous injections of placebo or rhPTH(1-84)

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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