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Study · Non-randomized trial · n = 44 · 2021

12 results

TransCon PTH as a Hormone Replacement Therapy for Patients with Hypoparathyroidism: 6-Month Update from the PaTH Forward Open-Label Extension

Rubin M, Rejnmark L, Schwarz P, Vokes T, Clarke B, Ahmed I, Hofbauer L, Palermo A, Marcocci C, Pagotto U, Eriksen E, Mourya S and 4 more

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Markova D, Pihl S, Shu A, Khan A

Journal of the Endocrine Society3 May 2021

PMCIDPMC8090331 (opens in a new tab)PepBankPUB-99227949
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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 study12

12 results from studies that gave the peptide. 12 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
    titrated 6–30 µg PTH(1–34)/dayAs 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 uCa decreased from a baseline mean of 415 mg/24h to 178 mg/24h by Week 26 (n = 44) while maintaining sCa, and reducing sP and CaxP to fall within the normal range.
    2 context sentences
    Summary · context
    PaTH Forward is a phase 2, double-blind, placebo-controlled trial evaluating TransCon PTH in adult HP patients treated with SoC.
    Summary · context
    Subjects received fixed doses of TransCon PTH 15, 18, or 21 µg PTH(1–34)/day or placebo for 4 weeks, followed by an OLE period during which TransCon PTH dose was titrated (6–30 µg PTH[1–34]/day) per individual dosing requirement.
  2. 02HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism, TransCon PTH enabled standard-care independence in 82% versus 15% with placebo during the initial 4 weeks.

    In plain wordsIn adults with hypoparathyroidism, TransCon PTH enabled standard-care independence in 82% versus 15% with placebo during the initial 4 weeks.

    Peptide
    Palopegteriparatide
    Outcome
    IncreaseStandard-care independence at Week 4
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Supplement Requirements · Endocrine and hormones
    Studied dose
    15, 18, or 21 µg/day · 4 weeksAs given in this study (human).

    Measurements

    Independence
    82%
    TransCon PTH
    Independence
    15%
    placebo

    Source sentences

    Summary
    During the initial 4-week fixed-dose period of the PaTH Forward Trial, TransCon PTH enabled 82% of subjects to achieve independence from standard of care (SoC; no active vitamin D and Ca ≤ 500 mg/day) compared to 15% with placebo.
    2 context sentences
    Summary · context
    PaTH Forward is a phase 2, double-blind, placebo-controlled trial evaluating TransCon PTH in adult HP patients treated with SoC.
    Summary · context
    Subjects received fixed doses of TransCon PTH 15, 18, or 21 µg PTH(1–34)/day or placebo for 4 weeks, followed by an OLE period during which TransCon PTH dose was titrated (6–30 µg PTH[1–34]/day) per individual dosing requirement.
  3. 03HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism receiving TransCon PTH, 91% achieved standard-care independence by Week 26.

    In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, 91% achieved standard-care independence by Week 26.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableStandard-care independence at Week 26
    Study

    n: not reported in source

    Outcome group
    Supplement Requirements · Endocrine and hormones
    Studied dose
    titrated 6–30 µg PTH(1–34)/dayAs given in this study (human).

    Measurements

    Independence
    91%
    Week 26

    Source sentences

    Summary
    TransCon PTH enabled independence from SoC (no active vitamin D and Ca ≤ 500 mg/day) in 91% of subjects and independence from all supplements (no active vitamin D and no Ca) in 76% of subjects by Week 26.
    2 context sentences
    Summary · context
    PaTH Forward is a phase 2, double-blind, placebo-controlled trial evaluating TransCon PTH in adult HP patients treated with SoC.
    Summary · context
    Subjects received fixed doses of TransCon PTH 15, 18, or 21 µg PTH(1–34)/day or placebo for 4 weeks, followed by an OLE period during which TransCon PTH dose was titrated (6–30 µg PTH[1–34]/day) per individual dosing requirement.
  4. 04HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism receiving TransCon PTH, 76% achieved independence from active vitamin D and calcium by Week 26.

    In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, 76% needed neither active vitamin D nor calcium supplements by Week 26.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableIndependence from all supplements
    Study

    n: not reported in source

    Outcome group
    Supplement Requirements · Endocrine and hormones
    Studied dose
    titrated 6–30 µg PTH(1–34)/dayAs given in this study (human).

    Measurements

    Independence
    76%
    all supplements at Week 26

    Source sentences

    Summary
    TransCon PTH enabled independence from SoC (no active vitamin D and Ca ≤ 500 mg/day) in 91% of subjects and independence from all supplements (no active vitamin D and no Ca) in 76% of subjects by Week 26.
    2 context sentences
    Summary · context
    PaTH Forward is a phase 2, double-blind, placebo-controlled trial evaluating TransCon PTH in adult HP patients treated with SoC.
    Summary · context
    Subjects received fixed doses of TransCon PTH 15, 18, or 21 µg PTH(1–34)/day or placebo for 4 weeks, followed by an OLE period during which TransCon PTH dose was titrated (6–30 µg PTH[1–34]/day) per individual dosing requirement.
  5. 05HumanNon-randomized trialEfficacy outcome

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

    In plain wordsIn adults with hypoparathyroidism receiving TransCon PTH, serum calcium was maintained 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
    titrated 6–30 µg PTH(1–34)/dayAs given in this study (human).

    Source sentences

    Summary
    Mean 24-hour uCa decreased from a baseline mean of 415 mg/24h to 178 mg/24h by Week 26 (n = 44) while maintaining sCa, and reducing sP and CaxP to fall within the normal range.
    2 context sentences
    Summary · context
    PaTH Forward is a phase 2, double-blind, placebo-controlled trial evaluating TransCon PTH in adult HP patients treated with SoC.
    Summary · context
    Subjects received fixed doses of TransCon PTH 15, 18, or 21 µg PTH(1–34)/day or placebo for 4 weeks, followed by an OLE period during which TransCon PTH dose was titrated (6–30 µg PTH[1–34]/day) per individual dosing requirement.
  6. 06HumanNon-randomized trialEfficacy outcome

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

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

    Peptide
    Palopegteriparatide
    Outcome
    DecreaseSerum phosphate
    Study

    n: not reported in source

    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    titrated 6–30 µg PTH(1–34)/dayAs given in this study (human).

    Source sentences

    Summary
    Mean 24-hour uCa decreased from a baseline mean of 415 mg/24h to 178 mg/24h by Week 26 (n = 44) while maintaining sCa, and reducing sP and CaxP to fall within the normal range.
    2 context sentences
    Summary · context
    PaTH Forward is a phase 2, double-blind, placebo-controlled trial evaluating TransCon PTH in adult HP patients treated with SoC.
    Summary · context
    Subjects received fixed doses of TransCon PTH 15, 18, or 21 µg PTH(1–34)/day or placebo for 4 weeks, followed by an OLE period during which TransCon PTH dose was titrated (6–30 µg PTH[1–34]/day) per individual dosing requirement.
  7. 07HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism receiving TransCon PTH, calcium-phosphate product decreased into the normal range by Week 26.

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

    Peptide
    Palopegteriparatide
    Outcome
    DecreaseCalcium-phosphate product
    Study

    n: not reported in source

    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    titrated 6–30 µg PTH(1–34)/dayAs given in this study (human).

    Source sentences

    Summary
    Mean 24-hour uCa decreased from a baseline mean of 415 mg/24h to 178 mg/24h by Week 26 (n = 44) while maintaining sCa, and reducing sP and CaxP to fall within the normal range.
    2 context sentences
    Summary · context
    PaTH Forward is a phase 2, double-blind, placebo-controlled trial evaluating TransCon PTH in adult HP patients treated with SoC.
    Summary · context
    Subjects received fixed doses of TransCon PTH 15, 18, or 21 µg PTH(1–34)/day or placebo for 4 weeks, followed by an OLE period during which TransCon PTH dose was titrated (6–30 µg PTH[1–34]/day) per individual dosing requirement.
  8. 08HumanNon-randomized trialEfficacy outcome

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

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

    Peptide
    Palopegteriparatide
    Outcome
    IncreaseSF-36 summary and domain scores
    Study

    n: not reported in source

    Outcome group
    Quality of life · Endocrine and hormones
    Studied dose
    titrated 6–30 µg PTH(1–34)/dayAs given in this study (human).

    Source sentences

    Summary
    The mean scores for all SF-36 summary and domains increased from below normal at baseline to within the normal range by Week 26.
    2 context sentences
    Summary · context
    PaTH Forward is a phase 2, double-blind, placebo-controlled trial evaluating TransCon PTH in adult HP patients treated with SoC.
    Summary · context
    Subjects received fixed doses of TransCon PTH 15, 18, or 21 µg PTH(1–34)/day or placebo for 4 weeks, followed by an OLE period during which TransCon PTH dose was titrated (6–30 µg PTH[1–34]/day) per individual dosing requirement.
  9. 09HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism, HPES symptom scores improved through 26 weeks in TransCon PTH recipients and placebo recipients switching to TransCon PTH.

    In plain wordsIn adults with hypoparathyroidism, symptom scores improved through 26 weeks in TransCon PTH recipients and those switching from placebo.

    Peptide
    Palopegteriparatide
    Outcome
    Direction not reportedHPES symptom score
    Study

    n: not reported in source

    Outcome group
    Quality of life · Endocrine and hormones
    Studied dose
    titrated 6–30 µg PTH(1–34)/dayAs given in this study (human).

    Source sentences

    Summary
    The HPES Symptom and Impact scores continuously improved through 26 weeks for TransCon PTH and placebo subjects switching to TransCon PTH.
    2 context sentences
    Summary · context
    PaTH Forward is a phase 2, double-blind, placebo-controlled trial evaluating TransCon PTH in adult HP patients treated with SoC.
    Summary · context
    Subjects received fixed doses of TransCon PTH 15, 18, or 21 µg PTH(1–34)/day or placebo for 4 weeks, followed by an OLE period during which TransCon PTH dose was titrated (6–30 µg PTH[1–34]/day) per individual dosing requirement.
  10. 10HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism, HPES impact scores improved through 26 weeks in TransCon PTH recipients and placebo recipients switching to TransCon PTH.

    In plain wordsIn adults with hypoparathyroidism, impact scores improved through 26 weeks in TransCon PTH recipients and those switching from placebo.

    Peptide
    Palopegteriparatide
    Outcome
    Direction not reportedHPES impact score
    Study

    n: not reported in source

    Outcome group
    Quality of life · Endocrine and hormones
    Studied dose
    titrated 6–30 µg PTH(1–34)/dayAs given in this study (human).

    Source sentences

    Summary
    The HPES Symptom and Impact scores continuously improved through 26 weeks for TransCon PTH and placebo subjects switching to TransCon PTH.
    2 context sentences
    Summary · context
    PaTH Forward is a phase 2, double-blind, placebo-controlled trial evaluating TransCon PTH in adult HP patients treated with SoC.
    Summary · context
    Subjects received fixed doses of TransCon PTH 15, 18, or 21 µg PTH(1–34)/day or placebo for 4 weeks, followed by an OLE period during which TransCon PTH dose was titrated (6–30 µg PTH[1–34]/day) per individual dosing requirement.
  11. 11HumanNon-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
    titrated 6–30 µg PTH(1–34)/dayAs given in this study (human).

    Source sentences

    Summary
    TransCon PTH continued to be well-tolerated with no treatment-related serious or severe adverse events.
    2 context sentences
    Summary · context
    PaTH Forward is a phase 2, double-blind, placebo-controlled trial evaluating TransCon PTH in adult HP patients treated with SoC.
    Summary · context
    Subjects received fixed doses of TransCon PTH 15, 18, or 21 µg PTH(1–34)/day or placebo for 4 weeks, followed by an OLE period during which TransCon PTH dose was titrated (6–30 µg PTH[1–34]/day) per individual dosing requirement.
  12. 12HumanNon-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
    titrated 6–30 µg PTH(1–34)/dayAs given in this study (human).

    Source sentences

    Summary
    TransCon PTH continued to be well-tolerated with no treatment-related serious or severe adverse events.
    2 context sentences
    Summary · context
    PaTH Forward is a phase 2, double-blind, placebo-controlled trial evaluating TransCon PTH in adult HP patients treated with SoC.
    Summary · context
    Subjects received fixed doses of TransCon PTH 15, 18, or 21 µg PTH(1–34)/day or placebo for 4 weeks, followed by an OLE period during which TransCon PTH dose was titrated (6–30 µg PTH[1–34]/day) per individual dosing requirement.

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.

Publication types

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