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Study · Animal study (in vivo) · rat · 2017

13 results

Comparing the incidence of bone tumors in rats chronically exposed to the selective PTH type 1 receptor agonist abaloparatide or PTH(1-34).

Jolette J, Attalla B, Varela A, Long GG, Mellal N, Trimm S, Smith SY, Ominsky MS, Hattersley G

Regulatory toxicology and pharmacology : RTP4 Apr 2017Cited by 68 (Europe PMC)

PMID28389324 (opens in a new tab)DOI10.1016/j.yrtph.2017.04.001 (opens in a new tab)PepBankPUB-28389324
Publisher pagePubMedAsk about this study
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Summary

Prolonged treatment with human parathyroid hormone (hPTH) in rats results in development of bone tumors, though this finding has not been supported by clinical experience. The PTH type 1 receptor agonist abaloparatide, selected for its bone anabolic activity, is under clinical development to treat postmenopausal women with osteoporosis. To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years. Robust increases in bone density were achieved at all abaloparatide doses and with hPTH(1-34). Comprehensive histopathological analysis reflected a comparable continuum of proliferative changes in bone, mostly osteosarcoma, in both abaloparatide and hPTH(1-34) treated rats. Comparing the effects of abaloparatide and hPTH(1-34) at the 25 and 30 μg/kg respective doses, representing similar exposure multiples to the human therapeutic doses, revealed similar osteosarcoma-associated mortality, tumor incidence, age at first occurrence, and metastatic potential. There were no increases in the incidence of non-bone tumors with abaloparatide compared to vehicle. Thus, near life-long treatment with abaloparatide in rats resulted in dose and time dependent formation of osteosarcomas, with a comparable response to hPTH(1-34) at similar exposure.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study13

13 results from studies that gave the peptide. No result from this study comes from people.

  1. 01AnimalAnimal study (in vivo)Efficacy outcome

    In Fischer rats, abaloparatide robustly increased bone density at all tested doses.

    In plain wordsIn rats, abaloparatide increased bone density at all tested doses compared with vehicle.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseBone density
    Study

    ratn: not reported in source

    Fischer F344 rats
    Comparator
    vehicle
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    10, 25, and 50 μg/kg daily · subcutaneous · up to 2 yearsAs given in this study (rat).

    Source sentences

    Summary
    Robust increases in bone density were achieved at all abaloparatide doses and with hPTH(1-34).
    1 context sentence
    Summary · context
    To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years.
  2. 02AnimalAnimal study (in vivo)Efficacy outcome

    In Fischer rats, hPTH(1-34) robustly increased bone density.

    In plain wordsIn rats, hPTH(1-34) increased bone density compared with vehicle.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseBone density
    Study

    ratn: not reported in source

    Fischer F344 rats
    Comparator
    vehicle
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    30 μg/kg daily · subcutaneous · up to 2 yearsAs given in this study (rat).

    Source sentences

    Summary
    Robust increases in bone density were achieved at all abaloparatide doses and with hPTH(1-34).
    1 context sentence
    Summary · context
    To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years.
  3. 03AnimalAnimal study (in vivo)Safety outcome

    In Fischer rats, abaloparatide produced a continuum of proliferative bone changes, mostly osteosarcoma, comparable to hPTH(1-34).

    In plain wordsIn rats, abaloparatide produced bone lesions, mostly osteosarcoma, comparable to hPTH(1-34).

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    Not applicableProliferative bone lesions
    Study

    ratn: not reported in source

    Fischer F344 rats
    Comparator
    hPTH(1-34)
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    10, 25, and 50 μg/kg daily · subcutaneous · up to 2 yearsAs given in this study (rat).

    Source sentences

    Summary
    Comprehensive histopathological analysis reflected a comparable continuum of proliferative changes in bone, mostly osteosarcoma, in both abaloparatide and hPTH(1-34) treated rats.
    1 context sentence
    Summary · context
    To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years.
  4. 04AnimalAnimal study (in vivo)Safety outcome

    In Fischer rats, hPTH(1-34) produced a continuum of proliferative bone changes, mostly osteosarcoma, comparable to abaloparatide.

    In plain wordsIn rats, hPTH(1-34) produced bone lesions, mostly osteosarcoma, comparable to abaloparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    Not applicableProliferative bone lesions
    Study

    ratn: not reported in source

    Fischer F344 rats
    Comparator
    abaloparatide
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    30 μg/kg daily · subcutaneous · up to 2 yearsAs given in this study (rat).

    Source sentences

    Summary
    Comprehensive histopathological analysis reflected a comparable continuum of proliferative changes in bone, mostly osteosarcoma, in both abaloparatide and hPTH(1-34) treated rats.
    1 context sentence
    Summary · context
    To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years.
  5. 05AnimalAnimal study (in vivo)Safety outcome

    In Fischer rats, osteosarcoma-associated mortality was similar with exposure-matched abaloparatide and hPTH(1-34).

    In plain wordsIn rats, osteosarcoma-related mortality was similar with exposure-matched abaloparatide and hPTH(1-34).

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changeOsteosarcoma-associated mortality
    Study

    ratn: not reported in source

    Fischer F344 rats
    Comparator
    hPTH(1-34) 30 μg/kg daily
    Outcome group
    Mortality · Musculoskeletal
    Studied dose
    25 μg/kg daily · subcutaneous · up to 2 yearsAs given in this study (rat).

    Source sentences

    Summary
    Comparing the effects of abaloparatide and hPTH(1-34) at the 25 and 30 μg/kg respective doses, representing similar exposure multiples to the human therapeutic doses, revealed similar osteosarcoma-associated mortality, tumor incidence, age at first occurrence, and metastatic potential.
    1 context sentence
    Summary · context
    To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years.
  6. 06AnimalAnimal study (in vivo)Safety outcome

    In Fischer rats, osteosarcoma-associated mortality was similar with exposure-matched hPTH(1-34) and abaloparatide.

    In plain wordsIn rats, osteosarcoma-related mortality was similar with exposure-matched hPTH(1-34) and abaloparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeOsteosarcoma-associated mortality
    Study

    ratn: not reported in source

    Fischer F344 rats
    Comparator
    abaloparatide 25 μg/kg daily
    Outcome group
    Mortality · Musculoskeletal
    Studied dose
    30 μg/kg daily · subcutaneous · up to 2 yearsAs given in this study (rat).

    Source sentences

    Summary
    Comparing the effects of abaloparatide and hPTH(1-34) at the 25 and 30 μg/kg respective doses, representing similar exposure multiples to the human therapeutic doses, revealed similar osteosarcoma-associated mortality, tumor incidence, age at first occurrence, and metastatic potential.
    1 context sentence
    Summary · context
    To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years.
  7. 07AnimalAnimal study (in vivo)Safety outcome

    In Fischer rats, tumor incidence was similar with exposure-matched abaloparatide and hPTH(1-34).

    In plain wordsIn rats, tumor incidence was similar with exposure-matched abaloparatide and hPTH(1-34).

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changeTumor incidence
    Study

    ratn: not reported in source

    Fischer F344 rats
    Comparator
    hPTH(1-34) 30 μg/kg daily
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    25 μg/kg daily · subcutaneous · up to 2 yearsAs given in this study (rat).

    Source sentences

    Summary
    Comparing the effects of abaloparatide and hPTH(1-34) at the 25 and 30 μg/kg respective doses, representing similar exposure multiples to the human therapeutic doses, revealed similar osteosarcoma-associated mortality, tumor incidence, age at first occurrence, and metastatic potential.
    1 context sentence
    Summary · context
    To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years.
  8. 08AnimalAnimal study (in vivo)Safety outcome

    In Fischer rats, tumor incidence was similar with exposure-matched hPTH(1-34) and abaloparatide.

    In plain wordsIn rats, tumor incidence was similar with exposure-matched hPTH(1-34) and abaloparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeTumor incidence
    Study

    ratn: not reported in source

    Fischer F344 rats
    Comparator
    abaloparatide 25 μg/kg daily
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    30 μg/kg daily · subcutaneous · up to 2 yearsAs given in this study (rat).

    Source sentences

    Summary
    Comparing the effects of abaloparatide and hPTH(1-34) at the 25 and 30 μg/kg respective doses, representing similar exposure multiples to the human therapeutic doses, revealed similar osteosarcoma-associated mortality, tumor incidence, age at first occurrence, and metastatic potential.
    1 context sentence
    Summary · context
    To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years.
  9. 09AnimalAnimal study (in vivo)Safety outcome

    In Fischer rats, age at first tumor occurrence was similar with exposure-matched abaloparatide and hPTH(1-34).

    In plain wordsIn rats, tumors first appeared at similar ages with exposure-matched abaloparatide and hPTH(1-34).

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changeAge at first tumor occurrence
    Study

    ratn: not reported in source

    Fischer F344 rats
    Comparator
    hPTH(1-34) 30 μg/kg daily
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    25 μg/kg daily · subcutaneous · up to 2 yearsAs given in this study (rat).

    Source sentences

    Summary
    Comparing the effects of abaloparatide and hPTH(1-34) at the 25 and 30 μg/kg respective doses, representing similar exposure multiples to the human therapeutic doses, revealed similar osteosarcoma-associated mortality, tumor incidence, age at first occurrence, and metastatic potential.
    1 context sentence
    Summary · context
    To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years.
  10. 10AnimalAnimal study (in vivo)Safety outcome

    In Fischer rats, age at first tumor occurrence was similar with exposure-matched hPTH(1-34) and abaloparatide.

    In plain wordsIn rats, tumors first appeared at similar ages with exposure-matched hPTH(1-34) and abaloparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeAge at first tumor occurrence
    Study

    ratn: not reported in source

    Fischer F344 rats
    Comparator
    abaloparatide 25 μg/kg daily
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    30 μg/kg daily · subcutaneous · up to 2 yearsAs given in this study (rat).

    Source sentences

    Summary
    Comparing the effects of abaloparatide and hPTH(1-34) at the 25 and 30 μg/kg respective doses, representing similar exposure multiples to the human therapeutic doses, revealed similar osteosarcoma-associated mortality, tumor incidence, age at first occurrence, and metastatic potential.
    1 context sentence
    Summary · context
    To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years.
  11. 11AnimalAnimal study (in vivo)Safety outcome

    In Fischer rats, metastatic potential was similar with exposure-matched abaloparatide and hPTH(1-34).

    In plain wordsIn rats, metastatic potential was similar with exposure-matched abaloparatide and hPTH(1-34).

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changeMetastatic potential
    Study

    ratn: not reported in source

    Fischer F344 rats
    Comparator
    hPTH(1-34) 30 μg/kg daily
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    25 μg/kg daily · subcutaneous · up to 2 yearsAs given in this study (rat).

    Source sentences

    Summary
    Comparing the effects of abaloparatide and hPTH(1-34) at the 25 and 30 μg/kg respective doses, representing similar exposure multiples to the human therapeutic doses, revealed similar osteosarcoma-associated mortality, tumor incidence, age at first occurrence, and metastatic potential.
    1 context sentence
    Summary · context
    To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years.
  12. 12AnimalAnimal study (in vivo)Safety outcome

    In Fischer rats, metastatic potential was similar with exposure-matched hPTH(1-34) and abaloparatide.

    In plain wordsIn rats, metastatic potential was similar with exposure-matched hPTH(1-34) and abaloparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeMetastatic potential
    Study

    ratn: not reported in source

    Fischer F344 rats
    Comparator
    abaloparatide 25 μg/kg daily
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    30 μg/kg daily · subcutaneous · up to 2 yearsAs given in this study (rat).

    Source sentences

    Summary
    Comparing the effects of abaloparatide and hPTH(1-34) at the 25 and 30 μg/kg respective doses, representing similar exposure multiples to the human therapeutic doses, revealed similar osteosarcoma-associated mortality, tumor incidence, age at first occurrence, and metastatic potential.
    1 context sentence
    Summary · context
    To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years.
  13. 13AnimalAnimal study (in vivo)Safety outcome

    In Fischer rats, abaloparatide did not increase non-bone tumor incidence compared with vehicle.

    In plain wordsIn rats, abaloparatide did not increase tumors outside bone compared with vehicle.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changeNon-bone tumor incidence
    Study

    ratn: not reported in source

    Fischer F344 rats
    Comparator
    vehicle
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    10, 25, and 50 μg/kg daily · subcutaneous · up to 2 yearsAs given in this study (rat).

    Source sentences

    Summary
    There were no increases in the incidence of non-bone tumors with abaloparatide compared to vehicle.
    1 context sentence
    Summary · context
    To determine the carcinogenic potential of abaloparatide, Fischer (F344) rats were administered SC daily abaloparatide at doses of 0, 10, 25, and 50 μg/kg or 30 μg/kg hPTH(1-34) as a positive control for up to 2 years.

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 3Current

    22 Oct 2026, 02:25 UTC

    Study results updated

  2. Version 2

    21 Oct 2026, 18:59 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

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