Defining a noncarcinogenic dose of recombinant human parathyroid hormone 1-84 in a 2-year study in Fischer 344 rats.

Jolette J, Wilker CE, Smith SY, Doyle N, Hardisty JF, Metcalfe AJ, Marriott TB, Fox J, Wells DS

Toxicologic pathology1 Jan 2006Cited by 91 (Europe PMC)

PMID17178693DOI10.1080/01926230601072301PepBankPUB-17178693

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 Fischer 344 rats, all PTH doses caused widespread osteosclerosis.
In plain wordsIn rats, all PTH doses caused widespread osteosclerosis.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseOsteosclerosis
Study
ratn: not reported in source
Fischer 344 rats
Outcome group
Bone and joint · Musculoskeletal
Studied dose
10, 50, 150 microg/kg/day · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
All PTH doses caused widespread osteosclerosis and significant, dose-dependent increases in femoral and vertebral bone mineral content and density.
1 context sentence(design, population, supporting numbers)
Summary · context
The carcinogenic potential of human parathyroid hormone 1-84 (PTH) was assessed by daily subcutaneous injection (0, 10, 50, 150 microg/kg/day) for 2 years in Fischer 344 rats.
Report a problemFND-1717869301
02AnimalAnimal study (in vivo)Efficacy outcome
In Fischer 344 rats, PTH significantly increased femoral bone mineral content in a dose-dependent manner.
In plain wordsIn rats, PTH increased femoral bone mineral content with increasing dose.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseFemoral bone mineral content
Study
ratn: not reported in source
Fischer 344 rats
Outcome group
Bone and joint · Musculoskeletal
Studied dose
10, 50, 150 microg/kg/day · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
All PTH doses caused widespread osteosclerosis and significant, dose-dependent increases in femoral and vertebral bone mineral content and density.
1 context sentence(design, population, supporting numbers)
Summary · context
The carcinogenic potential of human parathyroid hormone 1-84 (PTH) was assessed by daily subcutaneous injection (0, 10, 50, 150 microg/kg/day) for 2 years in Fischer 344 rats.
Report a problemFND-1717869302
03AnimalAnimal study (in vivo)Efficacy outcome
In Fischer 344 rats, PTH significantly increased vertebral bone mineral content in a dose-dependent manner.
In plain wordsIn rats, PTH increased vertebral bone mineral content with increasing dose.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseVertebral bone mineral content
Study
ratn: not reported in source
Fischer 344 rats
Outcome group
Bone and joint · Musculoskeletal
Studied dose
10, 50, 150 microg/kg/day · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
All PTH doses caused widespread osteosclerosis and significant, dose-dependent increases in femoral and vertebral bone mineral content and density.
1 context sentence(design, population, supporting numbers)
Summary · context
The carcinogenic potential of human parathyroid hormone 1-84 (PTH) was assessed by daily subcutaneous injection (0, 10, 50, 150 microg/kg/day) for 2 years in Fischer 344 rats.
Report a problemFND-1717869303
04AnimalAnimal study (in vivo)Efficacy outcome
In Fischer 344 rats, PTH significantly increased femoral bone mineral density in a dose-dependent manner.
In plain wordsIn rats, PTH increased femoral bone density with increasing dose.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseFemoral bone mineral density
Study
ratn: not reported in source
Fischer 344 rats
Outcome group
Bone and joint · Musculoskeletal
Studied dose
10, 50, 150 microg/kg/day · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
All PTH doses caused widespread osteosclerosis and significant, dose-dependent increases in femoral and vertebral bone mineral content and density.
1 context sentence(design, population, supporting numbers)
Summary · context
The carcinogenic potential of human parathyroid hormone 1-84 (PTH) was assessed by daily subcutaneous injection (0, 10, 50, 150 microg/kg/day) for 2 years in Fischer 344 rats.
Report a problemFND-1717869304
05AnimalAnimal study (in vivo)Efficacy outcome
In Fischer 344 rats, PTH significantly increased vertebral bone mineral density in a dose-dependent manner.
In plain wordsIn rats, PTH increased vertebral bone density with increasing dose.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseVertebral bone mineral density
Study
ratn: not reported in source
Fischer 344 rats
Outcome group
Bone and joint · Musculoskeletal
Studied dose
10, 50, 150 microg/kg/day · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
All PTH doses caused widespread osteosclerosis and significant, dose-dependent increases in femoral and vertebral bone mineral content and density.
1 context sentence(design, population, supporting numbers)
Summary · context
The carcinogenic potential of human parathyroid hormone 1-84 (PTH) was assessed by daily subcutaneous injection (0, 10, 50, 150 microg/kg/day) for 2 years in Fischer 344 rats.
Report a problemFND-1717869305
06AnimalAnimal study (in vivo)Safety outcome
In Fischer 344 rats, proliferative bone changes increased with dose in the middle and high PTH groups.
In plain wordsIn rats, proliferative bone changes increased with dose in the middle and high PTH groups.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseProliferative bone changes
Study
ratn: not reported in source
Fischer 344 rats
Outcome group
Bone and joint · Musculoskeletal
Studied dose
50 and 150 microg/kg/day · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
In the mid-and high-dose groups, proliferative changes in bone increased with dose.
1 context sentence(design, population, supporting numbers)
Summary · context
The carcinogenic potential of human parathyroid hormone 1-84 (PTH) was assessed by daily subcutaneous injection (0, 10, 50, 150 microg/kg/day) for 2 years in Fischer 344 rats.
Report a problemFND-1717869306
07AnimalAnimal study (in vivo)Safety outcome
In PTH-treated Fischer 344 rats, osteosarcoma was the most common proliferative bone change.
In plain wordsIn PTH-treated rats, osteosarcoma was the most common proliferative bone change.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableOsteosarcoma
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
Osteosarcoma was the most common change, followed by focal osteoblast hyperplasia, osteoblastoma, osteoma and skeletal fibrosarcoma.
1 context sentence(design, population, supporting numbers)
Summary · context
The carcinogenic potential of human parathyroid hormone 1-84 (PTH) was assessed by daily subcutaneous injection (0, 10, 50, 150 microg/kg/day) for 2 years in Fischer 344 rats.
Report a problemFND-1717869307
08AnimalAnimal study (in vivo)Safety outcome
In PTH-treated Fischer 344 rats, focal osteoblast hyperplasia followed osteosarcoma in frequency.
In plain wordsIn PTH-treated rats, focal osteoblast hyperplasia occurred.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableFocal osteoblast hyperplasia
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
Osteosarcoma was the most common change, followed by focal osteoblast hyperplasia, osteoblastoma, osteoma and skeletal fibrosarcoma.
1 context sentence(design, population, supporting numbers)
Summary · context
The carcinogenic potential of human parathyroid hormone 1-84 (PTH) was assessed by daily subcutaneous injection (0, 10, 50, 150 microg/kg/day) for 2 years in Fischer 344 rats.
Report a problemFND-1717869308
09AnimalAnimal study (in vivo)Safety outcome
In PTH-treated Fischer 344 rats, osteoblastoma occurred among proliferative bone changes.
In plain wordsIn PTH-treated rats, osteoblastoma occurred.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableOsteoblastoma
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
Osteosarcoma was the most common change, followed by focal osteoblast hyperplasia, osteoblastoma, osteoma and skeletal fibrosarcoma.
1 context sentence(design, population, supporting numbers)
Summary · context
The carcinogenic potential of human parathyroid hormone 1-84 (PTH) was assessed by daily subcutaneous injection (0, 10, 50, 150 microg/kg/day) for 2 years in Fischer 344 rats.
Report a problemFND-1717869309
10AnimalAnimal study (in vivo)Safety outcome
In PTH-treated Fischer 344 rats, osteoma occurred among proliferative bone changes.
In plain wordsIn PTH-treated rats, osteoma occurred.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableOsteoma
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
Osteosarcoma was the most common change, followed by focal osteoblast hyperplasia, osteoblastoma, osteoma and skeletal fibrosarcoma.
1 context sentence(design, population, supporting numbers)
Summary · context
The carcinogenic potential of human parathyroid hormone 1-84 (PTH) was assessed by daily subcutaneous injection (0, 10, 50, 150 microg/kg/day) for 2 years in Fischer 344 rats.
Report a problemFND-1717869310
11AnimalAnimal study (in vivo)Safety outcome
In PTH-treated Fischer 344 rats, skeletal fibrosarcoma occurred among proliferative bone changes.
In plain wordsIn PTH-treated rats, skeletal fibrosarcoma occurred.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableSkeletal fibrosarcoma
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
Osteosarcoma was the most common change, followed by focal osteoblast hyperplasia, osteoblastoma, osteoma and skeletal fibrosarcoma.
1 context sentence(design, population, supporting numbers)
Summary · context
The carcinogenic potential of human parathyroid hormone 1-84 (PTH) was assessed by daily subcutaneous injection (0, 10, 50, 150 microg/kg/day) for 2 years in Fischer 344 rats.
Report a problemFND-1717869311
12AnimalAnimal study (in vivo)Safety outcome
In Fischer 344 rats, bone neoplasm incidence at the low PTH dose was comparable to control.
In plain wordsIn rats, bone tumor incidence at the low PTH dose was similar to control.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
No significant changeBone neoplasm incidence at low dose
Study
ratn: not reported in source
Fischer 344 rats
Comparator
Control
Outcome group
Bone and joint · Musculoskeletal
Studied dose
10 microg/kg/day · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
The incidence of bone neoplasms was comparable in control and low-dose groups providing a noncarcinogenic dose for PTH of 10 microg/kg/day at a systemic exposure to PTH that is 4.6-fold higher than for a 100 microg dose in humans.
1 context sentence(design, population, supporting numbers)
Summary · context
The carcinogenic potential of human parathyroid hormone 1-84 (PTH) was assessed by daily subcutaneous injection (0, 10, 50, 150 microg/kg/day) for 2 years in Fischer 344 rats.
Report a problemFND-1717869312
13AnimalAnimal study (in vivo)Pharmacokinetics
In Fischer 344 rats, the noncarcinogenic PTH dose produced systemic exposure 4.6-fold higher than a 100 microg human dose.
In plain wordsIn rats, the noncarcinogenic PTH dose produced higher systemic exposure than the stated human dose.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseSystemic exposure at noncarcinogenic dose
Study
ratn: not reported in source
Fischer 344 rats
Comparator
100 microg human dose
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
10 microg/kg/day · subcutaneous · 2 yearsAs given in this study (rat).
Source sentences
Summary
The incidence of bone neoplasms was comparable in control and low-dose groups providing a noncarcinogenic dose for PTH of 10 microg/kg/day at a systemic exposure to PTH that is 4.6-fold higher than for a 100 microg dose in humans.
1 context sentence(design, population, supporting numbers)
Summary · context
The carcinogenic potential of human parathyroid hormone 1-84 (PTH) was assessed by daily subcutaneous injection (0, 10, 50, 150 microg/kg/day) for 2 years in Fischer 344 rats.
Report a problemFND-1717869313

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
28 Oct 2026, 02:03 UTC
Study results updated
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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