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Study · Non-randomized trial · 2026

12 results

Palopegteriparatide for adults with chronic hypoparathyroidism: skeletal dynamics through 3 years of the phase 2 PaTH forward trial.

Rubin MR, Clarke BL, Hofbauer LC, Khan A, Schwarz P, Vokes T, Ahmed I, Palermo A, Cetani F, Pagotto U, Zhao C, Ominsky MS and 4 more

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Lai B, Ukena J, Shu AD, Rejnmark L

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research1 Sept 2026Cited by 7 (Europe PMC)

Summary

Hypoparathyroidism is an endocrine disease caused by insufficient levels of PTH, which acts directly on bone and kidney and indirectly on the intestine to regulate calcium and phosphate balance. In clinical trials, palopegteriparatide (TransCon PTH) treatment enabled independence from conventional therapy (no active vitamin D, ≤600 mg/d calcium) and maintained serum biochemistries within normal ranges. The current analyses describe patterns of change in BMD, serum bone turnover markers, and serum and urine calcium in adults with chronic hypoparathyroidism treated with palopegteriparatide through 3 years of the PaTH Forward trial. Baseline BMD Z-scores for the LS, TH, FN, and 1/3 distal radius were above zero, indicating bone mass exceeding age-adjusted normative values. BMD decreased from these elevated baseline levels with palopegteriparatide treatment, with larger reductions during the first 26 weeks and modest declines thereafter. Mean BMD Z-scores at week 162 remained above zero for all 4 sites. Participants with lower baseline BMD (Z-scores below -1 and T-scores below -2.5) generally exhibited lesser declines in BMD versus those with higher baseline BMD. Palopegteriparatide treatment was associated with early increases in bone resorption (serum C-terminal telopeptide of type I collagen, CTx) and bone formation (serum procollagen type 1 N-terminal propeptide, P1NP) that peaked at weeks 12 and 26, respectively, followed by declines to levels moderately higher than baseline at week 162. Mean CTx and P1NP in the overall population and the subgroup of postmenopausal women were below their upper limits of normal from weeks 58-162. At week 162, mean serum and median urine calcium remained within normal ranges and 91% of participants were independent from conventional therapy. These results suggest that long-term palopegteriparatide therapy in adults with chronic hypoparathyroidism gradually returns the skeleton toward its natural state thereby enhancing the skeleton's contribution to calcium homeostasis.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

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, BMD decreased during palopegteriparatide treatment, with larger reductions during the first 26 weeks and modest declines thereafter.

    In plain wordsIn adults with hypoparathyroidism, bone density decreased from elevated baseline levels during palopegteriparatide treatment.

    Outcome
    DecreaseBone mineral density change
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    BMD decreased from these elevated baseline levels with palopegteriparatide treatment, with larger reductions during the first 26 weeks and modest declines thereafter.
    1 context sentence
    Summary · context
    The current analyses describe patterns of change in BMD, serum bone turnover markers, and serum and urine calcium in adults with chronic hypoparathyroidism treated with palopegteriparatide through 3 years of the PaTH Forward trial.
  2. 02HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism receiving palopegteriparatide, mean BMD Z-scores remained above zero at all 4 sites at week 162.

    In plain wordsAt week 162, mean bone density remained above age-adjusted norms at all measured sites during palopegteriparatide treatment.

    Outcome
    Not applicableBMD Z-scores at week 162
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Mean BMD Z-scores at week 162 remained above zero for all 4 sites.
    2 context sentences
    Summary · context
    Baseline BMD Z-scores for the LS, TH, FN, and 1/3 distal radius were above zero, indicating bone mass exceeding age-adjusted normative values.
    Summary · context
    The current analyses describe patterns of change in BMD, serum bone turnover markers, and serum and urine calcium in adults with chronic hypoparathyroidism treated with palopegteriparatide through 3 years of the PaTH Forward trial.
  3. 03HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism, CTx increased during palopegteriparatide treatment, peaked at week 12, then declined but remained moderately above baseline at week 162.

    In plain wordsDuring palopegteriparatide treatment, bone resorption markers rose, peaked, then declined but remained above baseline.

    Outcome
    MixedCTx trajectory
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Palopegteriparatide treatment was associated with early increases in bone resorption (serum C-terminal telopeptide of type I collagen, CTx) and bone formation (serum procollagen type 1 N-terminal propeptide, P1NP) that peaked at weeks 12 and 26, respectively, followed by declines to levels moderately higher than baseline at week 162.
    1 context sentence
    Summary · context
    The current analyses describe patterns of change in BMD, serum bone turnover markers, and serum and urine calcium in adults with chronic hypoparathyroidism treated with palopegteriparatide through 3 years of the PaTH Forward trial.
  4. 04HumanNon-randomized trialEfficacy outcome

    In adults with hypoparathyroidism, P1NP increased during palopegteriparatide treatment, peaked at week 26, then declined but remained moderately above baseline at week 162.

    In plain wordsDuring palopegteriparatide treatment, bone formation markers rose, peaked, then declined but remained above baseline.

    Outcome
    MixedP1NP trajectory
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Palopegteriparatide treatment was associated with early increases in bone resorption (serum C-terminal telopeptide of type I collagen, CTx) and bone formation (serum procollagen type 1 N-terminal propeptide, P1NP) that peaked at weeks 12 and 26, respectively, followed by declines to levels moderately higher than baseline at week 162.
    1 context sentence
    Summary · context
    The current analyses describe patterns of change in BMD, serum bone turnover markers, and serum and urine calcium in adults with chronic hypoparathyroidism treated with palopegteriparatide through 3 years of the PaTH Forward trial.
  5. 05HumanNon-randomized trialEfficacy outcome

    During palopegteriparatide treatment, mean CTx in adults with hypoparathyroidism stayed below its upper normal limit from weeks 58-162.

    In plain wordsDuring palopegteriparatide treatment, mean CTx remained below its upper normal limit from weeks 58-162.

    Outcome
    Not applicableCTx relative to normal limits
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Mean CTx and P1NP in the overall population and the subgroup of postmenopausal women were below their upper limits of normal from weeks 58-162.
    1 context sentence
    Summary · context
    The current analyses describe patterns of change in BMD, serum bone turnover markers, and serum and urine calcium in adults with chronic hypoparathyroidism treated with palopegteriparatide through 3 years of the PaTH Forward trial.
  6. 06HumanNon-randomized trialEfficacy outcome

    During palopegteriparatide treatment, mean P1NP in adults with hypoparathyroidism stayed below its upper normal limit from weeks 58-162.

    In plain wordsDuring palopegteriparatide treatment, mean P1NP remained below its upper normal limit from weeks 58-162.

    Outcome
    Not applicableP1NP relative to normal limits
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Mean CTx and P1NP in the overall population and the subgroup of postmenopausal women were below their upper limits of normal from weeks 58-162.
    1 context sentence
    Summary · context
    The current analyses describe patterns of change in BMD, serum bone turnover markers, and serum and urine calcium in adults with chronic hypoparathyroidism treated with palopegteriparatide through 3 years of the PaTH Forward trial.
  7. 07HumanNon-randomized trialEfficacy outcome

    During palopegteriparatide treatment, mean CTx in postmenopausal women stayed below its upper normal limit from weeks 58-162.

    In plain wordsDuring palopegteriparatide treatment, mean CTx in postmenopausal women remained below its upper normal limit.

    Outcome
    Not applicableCTx in postmenopausal women
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Mean CTx and P1NP in the overall population and the subgroup of postmenopausal women were below their upper limits of normal from weeks 58-162.
    1 context sentence
    Summary · context
    The current analyses describe patterns of change in BMD, serum bone turnover markers, and serum and urine calcium in adults with chronic hypoparathyroidism treated with palopegteriparatide through 3 years of the PaTH Forward trial.
  8. 08HumanNon-randomized trialEfficacy outcome

    During palopegteriparatide treatment, mean P1NP in postmenopausal women stayed below its upper normal limit from weeks 58-162.

    In plain wordsDuring palopegteriparatide treatment, mean P1NP in postmenopausal women remained below its upper normal limit.

    Outcome
    Not applicableP1NP in postmenopausal women
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Mean CTx and P1NP in the overall population and the subgroup of postmenopausal women were below their upper limits of normal from weeks 58-162.
    1 context sentence
    Summary · context
    The current analyses describe patterns of change in BMD, serum bone turnover markers, and serum and urine calcium in adults with chronic hypoparathyroidism treated with palopegteriparatide through 3 years of the PaTH Forward trial.
  9. 09HumanNon-randomized trialEfficacy outcome

    At week 162, mean serum calcium remained normal in adults with hypoparathyroidism receiving palopegteriparatide.

    In plain wordsAt week 162, mean blood calcium remained normal during palopegteriparatide treatment.

    Outcome
    Not applicableSerum calcium at week 162
    Study

    n: not reported in source

    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    Dose not stated

    Source sentences

    Summary
    At week 162, mean serum and median urine calcium remained within normal ranges and 91% of participants were independent from conventional therapy.
    1 context sentence
    Summary · context
    The current analyses describe patterns of change in BMD, serum bone turnover markers, and serum and urine calcium in adults with chronic hypoparathyroidism treated with palopegteriparatide through 3 years of the PaTH Forward trial.
  10. 10HumanNon-randomized trialEfficacy outcome

    At week 162, median urine calcium remained normal in adults with hypoparathyroidism receiving palopegteriparatide.

    In plain wordsAt week 162, median urine calcium remained normal during palopegteriparatide treatment.

    Outcome
    Not applicableUrine calcium at week 162
    Study

    n: not reported in source

    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    Dose not stated

    Source sentences

    Summary
    At week 162, mean serum and median urine calcium remained within normal ranges and 91% of participants were independent from conventional therapy.
    1 context sentence
    Summary · context
    The current analyses describe patterns of change in BMD, serum bone turnover markers, and serum and urine calcium in adults with chronic hypoparathyroidism treated with palopegteriparatide through 3 years of the PaTH Forward trial.
  11. 11HumanNon-randomized trialEfficacy outcome

    At week 162, 91% of participants receiving palopegteriparatide were independent from conventional therapy, defined as no active vitamin D and ≤600 mg/d calcium.

    In plain wordsAt week 162, 91% of participants receiving palopegteriparatide needed no active vitamin D and ≤600 mg/d calcium.

    Outcome
    Not applicableIndependence from conventional therapy
    Study

    n: not reported in source

    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    Dose not stated

    Measurements

    Independent participants
    91%
    week 162

    Source sentences

    Summary
    At week 162, mean serum and median urine calcium remained within normal ranges and 91% of participants were independent from conventional therapy.
    2 context sentences
    Summary · context
    In clinical trials, palopegteriparatide (TransCon PTH) treatment enabled independence from conventional therapy (no active vitamin D, ≤600 mg/d calcium) and maintained serum biochemistries within normal ranges.
    Summary · context
    The current analyses describe patterns of change in BMD, serum bone turnover markers, and serum and urine calcium in adults with chronic hypoparathyroidism treated with palopegteriparatide through 3 years of the PaTH Forward trial.
  12. 12HumanObservational studyEfficacy outcome

    During palopegteriparatide treatment, participants with baseline BMD Z-scores below -1 and T-scores below -2.5 generally showed smaller declines than those with higher BMD.

    In plain wordsDuring palopegteriparatide treatment, lower starting bone density was linked to smaller declines than higher starting bone density.

    Outcome
    DecreaseBaseline BMD and subsequent decline
    Study

    n: not reported in source

    Comparator
    Higher baseline BMD
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Participants with lower baseline BMD (Z-scores below -1 and T-scores below -2.5) generally exhibited lesser declines in BMD versus those with higher baseline BMD.
    1 context sentence
    Summary · context
    The current analyses describe patterns of change in BMD, serum bone turnover markers, and serum and urine calcium in adults with chronic hypoparathyroidism treated with palopegteriparatide through 3 years of the PaTH Forward trial.

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

Registered trials1

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

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

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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