Skeletal changes in rats given daily subcutaneous injections of recombinant human parathyroid hormone (1-34) for 2 years and relevance to human safety.

Vahle JL, Sato M, Long GG, Young JK, Francis PC, Engelhardt JA, Westmore MS, Linda Y, Nold JB

Toxicologic pathology1 May 2002Cited by 447 (Europe PMC)

PMID12051548DOI10.1080/01926230252929882PepBankPUB-12051548

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: Publisher copyright. Results still quote short attributed sentences.

Results from this study13

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

01AnimalAnimal study (in vivo)Safety outcome
In male Fischer rats given PTH at 5 microg/kg, osteosarcoma occurred in 3 rats.
In plain wordsIn male rats given PTH at 5 microg/kg, 3 developed osteosarcoma.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableOsteosarcoma in males at low dose
Study
ratn = 60
Fischer 344 rats
Outcome group
Adverse events · Cancer
Studied dose
5 microg/kg daily · subcutaneous · 2 yearsAs given in this study (rat).
Measurements
Osteosarcoma cases
3 rats
Males at 5 microg/kg
Source sentences
Summary
Osteosarcoma occurred in 3, 21, and 31 male rats and in 4, 12, and 23 female rats in the 5-, 30-, and 75-microg/kg treatment groups, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Fischer 344 rats (60/sex/group) were given daily subcutaneous injections of recombinant human parathyroid hormone (PTH)(1-34) for 2 years at doses of 0, 5, 30, or 75 microg/kg.
Report a problemFND-1205154805
02AnimalAnimal study (in vivo)Safety outcome
In male Fischer rats given PTH at 30 microg/kg, osteosarcoma occurred in 21 rats.
In plain wordsIn male rats given PTH at 30 microg/kg, 21 developed osteosarcoma.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableOsteosarcoma in males at middle dose
Study
ratn = 60
Fischer 344 rats
Outcome group
Adverse events · Cancer
Studied dose
30 microg/kg daily · subcutaneous · 2 yearsAs given in this study (rat).
Measurements
Osteosarcoma cases
21 rats
Males at 30 microg/kg
Source sentences
Summary
Osteosarcoma occurred in 3, 21, and 31 male rats and in 4, 12, and 23 female rats in the 5-, 30-, and 75-microg/kg treatment groups, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Fischer 344 rats (60/sex/group) were given daily subcutaneous injections of recombinant human parathyroid hormone (PTH)(1-34) for 2 years at doses of 0, 5, 30, or 75 microg/kg.
Report a problemFND-1205154806
03AnimalAnimal study (in vivo)Safety outcome
In male Fischer rats given PTH at 75 microg/kg, osteosarcoma occurred in 31 rats.
In plain wordsIn male rats given PTH at 75 microg/kg, 31 developed osteosarcoma.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableOsteosarcoma in males at high dose
Study
ratn = 60
Fischer 344 rats
Outcome group
Adverse events · Cancer
Studied dose
75 microg/kg daily · subcutaneous · 2 yearsAs given in this study (rat).
Measurements
Osteosarcoma cases
31 rats
Males at 75 microg/kg
Source sentences
Summary
Osteosarcoma occurred in 3, 21, and 31 male rats and in 4, 12, and 23 female rats in the 5-, 30-, and 75-microg/kg treatment groups, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Fischer 344 rats (60/sex/group) were given daily subcutaneous injections of recombinant human parathyroid hormone (PTH)(1-34) for 2 years at doses of 0, 5, 30, or 75 microg/kg.
Report a problemFND-1205154807
04AnimalAnimal study (in vivo)Safety outcome
In female Fischer rats given PTH at 5 microg/kg, osteosarcoma occurred in 4 rats.
In plain wordsIn female rats given PTH at 5 microg/kg, 4 developed osteosarcoma.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableOsteosarcoma in females at low dose
Study
ratn = 60
Fischer 344 rats
Outcome group
Adverse events · Cancer
Studied dose
5 microg/kg daily · subcutaneous · 2 yearsAs given in this study (rat).
Measurements
Osteosarcoma cases
4 rats
Females at 5 microg/kg
Source sentences
Summary
Osteosarcoma occurred in 3, 21, and 31 male rats and in 4, 12, and 23 female rats in the 5-, 30-, and 75-microg/kg treatment groups, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Fischer 344 rats (60/sex/group) were given daily subcutaneous injections of recombinant human parathyroid hormone (PTH)(1-34) for 2 years at doses of 0, 5, 30, or 75 microg/kg.
Report a problemFND-1205154808
05AnimalAnimal study (in vivo)Safety outcome
In female Fischer rats given PTH at 30 microg/kg, osteosarcoma occurred in 12 rats.
In plain wordsIn female rats given PTH at 30 microg/kg, 12 developed osteosarcoma.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableOsteosarcoma in females at middle dose
Study
ratn = 60
Fischer 344 rats
Outcome group
Adverse events · Cancer
Studied dose
30 microg/kg daily · subcutaneous · 2 yearsAs given in this study (rat).
Measurements
Osteosarcoma cases
12 rats
Females at 30 microg/kg
Source sentences
Summary
Osteosarcoma occurred in 3, 21, and 31 male rats and in 4, 12, and 23 female rats in the 5-, 30-, and 75-microg/kg treatment groups, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Fischer 344 rats (60/sex/group) were given daily subcutaneous injections of recombinant human parathyroid hormone (PTH)(1-34) for 2 years at doses of 0, 5, 30, or 75 microg/kg.
Report a problemFND-1205154809
06AnimalAnimal study (in vivo)Safety outcome
In female Fischer rats given PTH at 75 microg/kg, osteosarcoma occurred in 23 rats.
In plain wordsIn female rats given PTH at 75 microg/kg, 23 developed osteosarcoma.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableOsteosarcoma in females at high dose
Study
ratn = 60
Fischer 344 rats
Outcome group
Adverse events · Cancer
Studied dose
75 microg/kg daily · subcutaneous · 2 yearsAs given in this study (rat).
Measurements
Osteosarcoma cases
23 rats
Females at 75 microg/kg
Source sentences
Summary
Osteosarcoma occurred in 3, 21, and 31 male rats and in 4, 12, and 23 female rats in the 5-, 30-, and 75-microg/kg treatment groups, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Fischer 344 rats (60/sex/group) were given daily subcutaneous injections of recombinant human parathyroid hormone (PTH)(1-34) for 2 years at doses of 0, 5, 30, or 75 microg/kg.
Report a problemFND-1205154810
07AnimalAnimal study (in vivo)Efficacy outcome
In Fischer rats, daily PTH markedly increased bone mass.
In plain wordsIn rats, daily PTH markedly increased bone mass.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseBone mass
Study
ratn: not reported in source
Fischer 344 rats
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
Treatment caused substantial increases in bone mass consistent with the known pharmacologic effects of once-daily administration. As determined by quantitative computed tomography (QCT) and histomorphometry, bone mass was markedly increased.
1 context sentence(design, population, supporting numbers)
Summary · context
Fischer 344 rats (60/sex/group) were given daily subcutaneous injections of recombinant human parathyroid hormone (PTH)(1-34) for 2 years at doses of 0, 5, 30, or 75 microg/kg.
Report a problemFND-1205154801
08AnimalAnimal study (in vivo)Efficacy outcome
In Fischer rats, PTH-induced new bone formation substantially decreased marrow space.
In plain wordsIn rats, new bone formation during PTH treatment reduced marrow space.
Peptide
Teriparatide (PTH 1-34)
Outcome
DecreaseMarrow space
Study
ratn: not reported in source
Fischer 344 rats
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
Substantial new bone formation resulted in a large decrease in marrow space accompanied by altered bone architecture.
1 context sentence(design, population, supporting numbers)
Summary · context
Fischer 344 rats (60/sex/group) were given daily subcutaneous injections of recombinant human parathyroid hormone (PTH)(1-34) for 2 years at doses of 0, 5, 30, or 75 microg/kg.
Report a problemFND-1205154802
09AnimalAnimal study (in vivo)Efficacy outcome
In Fischer rats, new bone formation during PTH treatment altered bone architecture.
In plain wordsIn rats, new bone formation during PTH treatment changed bone architecture.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedBone architecture
Study
ratn: not reported in source
Fischer 344 rats
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
Substantial new bone formation resulted in a large decrease in marrow space accompanied by altered bone architecture.
1 context sentence(design, population, supporting numbers)
Summary · context
Fischer 344 rats (60/sex/group) were given daily subcutaneous injections of recombinant human parathyroid hormone (PTH)(1-34) for 2 years at doses of 0, 5, 30, or 75 microg/kg.
Report a problemFND-1205154803
10AnimalAnimal study (in vivo)Safety outcome
In Fischer rats, bone proliferative lesions occurred in all PTH-treated groups.
In plain wordsIn rats, bone proliferative lesions occurred in all PTH-treated groups.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableBone proliferative lesions
Study
ratn: not reported in source
Fischer 344 rats
Outcome group
Adverse events · Musculoskeletal
Studied dose
Dose not stated · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
Bone proliferative lesions were observed in all PTH( 1-34)-treated groups.
1 context sentence(design, population, supporting numbers)
Summary · context
Fischer 344 rats (60/sex/group) were given daily subcutaneous injections of recombinant human parathyroid hormone (PTH)(1-34) for 2 years at doses of 0, 5, 30, or 75 microg/kg.
Report a problemFND-1205154804
11AnimalAnimal study (in vivo)Safety outcome
In PTH-treated Fischer rats, focal osteoblast hyperplasia was much less frequent than osteosarcoma.
In plain wordsIn rats treated with PTH, focal osteoblast hyperplasia was much less frequent than osteosarcoma.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableFocal osteoblast hyperplasia
Study
ratn: not reported in source
Fischer 344 rats
Outcome group
Adverse events · Cancer
Studied dose
Dose not stated · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
Focal osteoblast hyperplasia, osteoma, and osteoblastoma were much less frequent.
2 context sentences(design, population, supporting numbers)
Summary · context
Osteosarcoma occurred in 3, 21, and 31 male rats and in 4, 12, and 23 female rats in the 5-, 30-, and 75-microg/kg treatment groups, respectively.
Summary · context
Fischer 344 rats (60/sex/group) were given daily subcutaneous injections of recombinant human parathyroid hormone (PTH)(1-34) for 2 years at doses of 0, 5, 30, or 75 microg/kg.
Report a problemFND-1205154811
12AnimalAnimal study (in vivo)Safety outcome
In PTH-treated Fischer rats, osteoma was much less frequent than osteosarcoma.
In plain wordsIn rats treated with PTH, osteoma was much less frequent than osteosarcoma.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableOsteoma
Study
ratn: not reported in source
Fischer 344 rats
Outcome group
Adverse events · Cancer
Studied dose
Dose not stated · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
Focal osteoblast hyperplasia, osteoma, and osteoblastoma were much less frequent.
2 context sentences(design, population, supporting numbers)
Summary · context
Osteosarcoma occurred in 3, 21, and 31 male rats and in 4, 12, and 23 female rats in the 5-, 30-, and 75-microg/kg treatment groups, respectively.
Summary · context
Fischer 344 rats (60/sex/group) were given daily subcutaneous injections of recombinant human parathyroid hormone (PTH)(1-34) for 2 years at doses of 0, 5, 30, or 75 microg/kg.
Report a problemFND-1205154812
13AnimalAnimal study (in vivo)Safety outcome
In PTH-treated Fischer rats, osteoblastoma was much less frequent than osteosarcoma.
In plain wordsIn rats treated with PTH, osteoblastoma was much less frequent than osteosarcoma.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableOsteoblastoma
Study
ratn: not reported in source
Fischer 344 rats
Outcome group
Adverse events · Cancer
Studied dose
Dose not stated · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
Focal osteoblast hyperplasia, osteoma, and osteoblastoma were much less frequent.
2 context sentences(design, population, supporting numbers)
Summary · context
Osteosarcoma occurred in 3, 21, and 31 male rats and in 4, 12, and 23 female rats in the 5-, 30-, and 75-microg/kg treatment groups, respectively.
Summary · context
Fischer 344 rats (60/sex/group) were given daily subcutaneous injections of recombinant human parathyroid hormone (PTH)(1-34) for 2 years at doses of 0, 5, 30, or 75 microg/kg.
Report a problemFND-1205154813

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.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

Journal Article

MeSH terms

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