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Study · Non-randomized trial · n = 44 · 2022

10 results

PaTH Forward: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of TransCon PTH in Adult Hypoparathyroidism.

Khan AA, Rejnmark L, Rubin M, Schwarz P, Vokes T, Clarke B, Ahmed I, Hofbauer L, Marcocci C, Pagotto U, Palermo A, Eriksen E and 7 more

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Brod M, Markova D, Smith A, Pihl S, Mourya S, Karpf DB, Shu AD

The Journal of clinical endocrinology and metabolism1 Jan 2022Cited by 48 (Europe PMC)

PMID34347093 (opens in a new tab)PMCIDPMC8684498 (opens in a new tab)DOI10.1210/clinem/dgab577 (opens in a new tab)PepBankPUB-34347093
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism receiving TransCon PTH, mean urine calcium decreased from 415 to 178 mg/24h by Week 26.

    In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, urine calcium decreased from baseline by Week 26.

    Peptide
    Palopegteriparatide
    Outcome
    DecreaseUrinary calcium
    Study

    n = 44

    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    15, 18, or 21 µg PTH(1-34)/day for 4 weeks, then titrated 6-60 µg PTH(1-34)/day in a 22-week extensionAs given in this study (human).

    Measurements

    Urine calcium
    415 mg/24h
    baseline
    Urine calcium
    178 mg/24h
    Week 26

    Source sentences

    Summary
    Mean 24-hour urine Ca (uCa) decreased from a baseline mean of 415 mg/24h to 178 mg/24h by Week 26 (n = 44) while normal serum Ca (sCa) was maintained and serum phosphate and serum calcium-phosphate product fell within the normal range.
    2 context sentences
    Summary · context
    This phase 2, randomized, double-blind, placebo-controlled 4-week trial with open-label extension enrolled 59 individuals with hypoparathyroidism.
    Summary · context
    Interventions included TransCon PTH 15, 18, or 21 µg PTH(1-34)/day or placebo for 4 weeks, followed by a 22-week extension during which TransCon PTH dose was titrated (6-60 µg PTH[1-34]/day).
  2. 02HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism, 91% receiving TransCon PTH needed no active vitamin D and ≤500 mg/day calcium by Week 26.

    In plain wordsIn adults with hypoparathyroidism, 91% receiving TransCon PTH needed no active vitamin D and ≤500 mg/day calcium by Week 26.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableIndependence from standard care
    Study

    n: not reported in source

    Outcome group
    Supplement Requirements · Endocrine and hormones
    Studied dose
    15, 18, or 21 µg PTH(1-34)/day for 4 weeks, then titrated 6-60 µg PTH(1-34)/day in a 22-week extensionAs given in this study (human).

    Measurements

    Independence
    91%
    Week 26

    Source sentences

    Summary
    By Week 26, 91% of participants treated with TransCon PTH achieved independence from standard of care (SoC, defined as active vitamin D = 0 μg/day and calcium [Ca] ≤ 500 mg/day).
    2 context sentences
    Summary · context
    This phase 2, randomized, double-blind, placebo-controlled 4-week trial with open-label extension enrolled 59 individuals with hypoparathyroidism.
    Summary · context
    Interventions included TransCon PTH 15, 18, or 21 µg PTH(1-34)/day or placebo for 4 weeks, followed by a 22-week extension during which TransCon PTH dose was titrated (6-60 µg PTH[1-34]/day).
  3. 03HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism receiving TransCon PTH, normal serum calcium was maintained by Week 26.

    In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, serum calcium remained normal by Week 26.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableSerum calcium maintenance
    Study

    n: not reported in source

    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    15, 18, or 21 µg PTH(1-34)/day for 4 weeks, then titrated 6-60 µg PTH(1-34)/day in a 22-week extensionAs given in this study (human).

    Source sentences

    Summary
    Mean 24-hour urine Ca (uCa) decreased from a baseline mean of 415 mg/24h to 178 mg/24h by Week 26 (n = 44) while normal serum Ca (sCa) was maintained and serum phosphate and serum calcium-phosphate product fell within the normal range.
    2 context sentences
    Summary · context
    This phase 2, randomized, double-blind, placebo-controlled 4-week trial with open-label extension enrolled 59 individuals with hypoparathyroidism.
    Summary · context
    Interventions included TransCon PTH 15, 18, or 21 µg PTH(1-34)/day or placebo for 4 weeks, followed by a 22-week extension during which TransCon PTH dose was titrated (6-60 µg PTH[1-34]/day).
  4. 04HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism receiving TransCon PTH, serum phosphate fell within the normal range by Week 26.

    In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, serum phosphate fell within the normal range by Week 26.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableSerum phosphate
    Study

    n: not reported in source

    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    15, 18, or 21 µg PTH(1-34)/day for 4 weeks, then titrated 6-60 µg PTH(1-34)/day in a 22-week extensionAs given in this study (human).

    Source sentences

    Summary
    Mean 24-hour urine Ca (uCa) decreased from a baseline mean of 415 mg/24h to 178 mg/24h by Week 26 (n = 44) while normal serum Ca (sCa) was maintained and serum phosphate and serum calcium-phosphate product fell within the normal range.
    2 context sentences
    Summary · context
    This phase 2, randomized, double-blind, placebo-controlled 4-week trial with open-label extension enrolled 59 individuals with hypoparathyroidism.
    Summary · context
    Interventions included TransCon PTH 15, 18, or 21 µg PTH(1-34)/day or placebo for 4 weeks, followed by a 22-week extension during which TransCon PTH dose was titrated (6-60 µg PTH[1-34]/day).
  5. 05HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism receiving TransCon PTH, serum calcium-phosphate product fell within the normal range by Week 26.

    In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, the calcium-phosphate product fell within the normal range by Week 26.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableCalcium-phosphate product
    Study

    n: not reported in source

    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    15, 18, or 21 µg PTH(1-34)/day for 4 weeks, then titrated 6-60 µg PTH(1-34)/day in a 22-week extensionAs given in this study (human).

    Source sentences

    Summary
    Mean 24-hour urine Ca (uCa) decreased from a baseline mean of 415 mg/24h to 178 mg/24h by Week 26 (n = 44) while normal serum Ca (sCa) was maintained and serum phosphate and serum calcium-phosphate product fell within the normal range.
    2 context sentences
    Summary · context
    This phase 2, randomized, double-blind, placebo-controlled 4-week trial with open-label extension enrolled 59 individuals with hypoparathyroidism.
    Summary · context
    Interventions included TransCon PTH 15, 18, or 21 µg PTH(1-34)/day or placebo for 4 weeks, followed by a 22-week extension during which TransCon PTH dose was titrated (6-60 µg PTH[1-34]/day).
  6. 06HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism receiving TransCon PTH, mean SF-36 domain scores increased from below normal to normal by Week 26.

    In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, SF-36 domain scores increased from below normal to normal by Week 26.

    Peptide
    Palopegteriparatide
    Outcome
    IncreaseSF-36 domain scores
    Study

    n: not reported in source

    Outcome group
    Quality of life · Endocrine and hormones
    Studied dose
    15, 18, or 21 µg PTH(1-34)/day for 4 weeks, then titrated 6-60 µg PTH(1-34)/day in a 22-week extensionAs given in this study (human).

    Source sentences

    Summary
    By Week 26, mean scores on the generic 36-Item Short Form Health Survey domains increased from below normal at baseline to within the normal range.
    2 context sentences
    Summary · context
    This phase 2, randomized, double-blind, placebo-controlled 4-week trial with open-label extension enrolled 59 individuals with hypoparathyroidism.
    Summary · context
    Interventions included TransCon PTH 15, 18, or 21 µg PTH(1-34)/day or placebo for 4 weeks, followed by a 22-week extension during which TransCon PTH dose was titrated (6-60 µg PTH[1-34]/day).
  7. 07HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism receiving TransCon PTH, HPES symptom scores improved through 26 weeks.

    In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, symptom scores improved through 26 weeks.

    Peptide
    Palopegteriparatide
    Outcome
    Direction not reportedHPES symptom score
    Study

    n: not reported in source

    Outcome group
    Quality of life · Endocrine and hormones
    Studied dose
    15, 18, or 21 µg PTH(1-34)/day for 4 weeks, then titrated 6-60 µg PTH(1-34)/day in a 22-week extensionAs given in this study (human).

    Source sentences

    Summary
    The Hypoparathyroidism Patient Experience Scale symptom and impact scores improved through 26 weeks.
    2 context sentences
    Summary · context
    This phase 2, randomized, double-blind, placebo-controlled 4-week trial with open-label extension enrolled 59 individuals with hypoparathyroidism.
    Summary · context
    Interventions included TransCon PTH 15, 18, or 21 µg PTH(1-34)/day or placebo for 4 weeks, followed by a 22-week extension during which TransCon PTH dose was titrated (6-60 µg PTH[1-34]/day).
  8. 08HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism receiving TransCon PTH, HPES impact scores improved through 26 weeks.

    In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, impact scores improved through 26 weeks.

    Peptide
    Palopegteriparatide
    Outcome
    Direction not reportedHPES impact score
    Study

    n: not reported in source

    Outcome group
    Quality of life · Endocrine and hormones
    Studied dose
    15, 18, or 21 µg PTH(1-34)/day for 4 weeks, then titrated 6-60 µg PTH(1-34)/day in a 22-week extensionAs given in this study (human).

    Source sentences

    Summary
    The Hypoparathyroidism Patient Experience Scale symptom and impact scores improved through 26 weeks.
    2 context sentences
    Summary · context
    This phase 2, randomized, double-blind, placebo-controlled 4-week trial with open-label extension enrolled 59 individuals with hypoparathyroidism.
    Summary · context
    Interventions included TransCon PTH 15, 18, or 21 µg PTH(1-34)/day or placebo for 4 weeks, followed by a 22-week extension during which TransCon PTH dose was titrated (6-60 µg PTH[1-34]/day).
  9. 09HumanNon-randomized trialSafety outcome

    In adults with hypoparathyroidism receiving TransCon PTH, no treatment-related serious adverse events occurred.

    In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, no treatment-related serious adverse events occurred.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableTreatment-related serious adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    15, 18, or 21 µg PTH(1-34)/day for 4 weeks, then titrated 6-60 µg PTH(1-34)/day in a 22-week extensionAs given in this study (human).

    Source sentences

    Summary
    TransCon PTH was well tolerated with no treatment-related serious or severe adverse events.
    2 context sentences
    Summary · context
    This phase 2, randomized, double-blind, placebo-controlled 4-week trial with open-label extension enrolled 59 individuals with hypoparathyroidism.
    Summary · context
    Interventions included TransCon PTH 15, 18, or 21 µg PTH(1-34)/day or placebo for 4 weeks, followed by a 22-week extension during which TransCon PTH dose was titrated (6-60 µg PTH[1-34]/day).
  10. 10HumanNon-randomized trialSafety outcome

    In adults with hypoparathyroidism receiving TransCon PTH, no treatment-related severe adverse events occurred.

    In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, no treatment-related severe adverse events occurred.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableTreatment-related severe adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    15, 18, or 21 µg PTH(1-34)/day for 4 weeks, then titrated 6-60 µg PTH(1-34)/day in a 22-week extensionAs given in this study (human).

    Source sentences

    Summary
    TransCon PTH was well tolerated with no treatment-related serious or severe adverse events.
    2 context sentences
    Summary · context
    This phase 2, randomized, double-blind, placebo-controlled 4-week trial with open-label extension enrolled 59 individuals with hypoparathyroidism.
    Summary · context
    Interventions included TransCon PTH 15, 18, or 21 µg PTH(1-34)/day or placebo for 4 weeks, followed by a 22-week extension during which TransCon PTH dose was titrated (6-60 µg PTH[1-34]/day).

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

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 1 not yet recruiting · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Not yet recruitingPhase not statedNCT07160348

Translation and Validation of the Hypoparathyroidism Patient Experience Scales (HPES) Questionnaire in Greek

Aristotle University Of Thessalonikin = 200est. 1 Oct 2025 to est. 1 Apr 2026

Hypoparathyroidism

Trial pageClinicalTrials.govUpdated 8 Sept 2025
CompletedPhase 2Results postedNCT04009291

A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism

Ascendis Pharma A/Sn = 5927 Aug 2019 to 17 Apr 2025

Hypoparathyroidism · Endocrine System Diseases · Parathyroid Diseases

Trial pageClinicalTrials.govUpdated 18 Jun 2026

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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