Lack of bone neoplasms and persistence of bone efficacy in cynomolgus macaques after long-term treatment with teriparatide [rhPTH(1-34)].

Vahle JL, Zuehlke U, Schmidt A, Westmore M, Chen P, Sato M

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research1 Dec 2008Cited by 34 (Europe PMC)

PMID18684088DOI10.1359/jbmr.080807PepBankPUB-18684088

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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: 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)Efficacy outcome
In ovariectomized monkeys, teriparatide increased vertebral BMD by 29% versus controls after treatment.
In plain wordsIn monkeys with removed ovaries, teriparatide increased spinal bone density by 29% versus controls after treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseVertebral BMD
Study
cynomolgus monkeyn = 12
Ovariectomized skeletally mature cynomolgus monkeys
Comparator
OVX controls
Outcome group
Bone and joint · Musculoskeletal
Studied dose
5 microg/kg/d · subcutaneous · 18 monthsAs given in this study (cynomolgus monkey).
Measurements
Vertebral BMD increase
29%
versus OVX controls
Source sentences
Summary
After the 18-mo treatment period, vertebral BMD, BMC, and strength (ultimate load) were increased by 29%, 36%, and 52%, respectively, compared with OVX controls.
2 context sentences(design, population, supporting numbers)
Summary · context
Ovariectomized (OVX), skeletally mature, cynomolgus monkeys (n = 30 per group) were given teriparatide for 18 mo at either 0 or 5 microg/kg/d subcutaneously.
Summary · context
After 18 mo of treatment, subgroups of six monkeys from both groups were killed and evaluated, whereas all remaining monkeys entered a 3-yr observation period in which they did not receive teriparatide.
Report a problemFND-1868408801
02AnimalAnimal study (in vivo)Efficacy outcome
In ovariectomized monkeys, teriparatide increased vertebral BMC by 36% versus controls after treatment.
In plain wordsIn monkeys with removed ovaries, teriparatide increased spinal bone mineral content by 36% versus controls after treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseVertebral BMC
Study
cynomolgus monkeyn = 12
Ovariectomized skeletally mature cynomolgus monkeys
Comparator
OVX controls
Outcome group
Bone and joint · Musculoskeletal
Studied dose
5 microg/kg/d · subcutaneous · 18 monthsAs given in this study (cynomolgus monkey).
Measurements
Vertebral BMC increase
36%
versus OVX controls
Source sentences
Summary
After the 18-mo treatment period, vertebral BMD, BMC, and strength (ultimate load) were increased by 29%, 36%, and 52%, respectively, compared with OVX controls.
2 context sentences(design, population, supporting numbers)
Summary · context
Ovariectomized (OVX), skeletally mature, cynomolgus monkeys (n = 30 per group) were given teriparatide for 18 mo at either 0 or 5 microg/kg/d subcutaneously.
Summary · context
After 18 mo of treatment, subgroups of six monkeys from both groups were killed and evaluated, whereas all remaining monkeys entered a 3-yr observation period in which they did not receive teriparatide.
Report a problemFND-1868408802
03AnimalAnimal study (in vivo)Efficacy outcome
In ovariectomized monkeys, teriparatide increased vertebral strength by 52% versus controls after treatment.
In plain wordsIn monkeys with removed ovaries, teriparatide increased spinal bone strength by 52% versus controls after treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseVertebral ultimate load
Study
cynomolgus monkeyn = 12
Ovariectomized skeletally mature cynomolgus monkeys
Comparator
OVX controls
Outcome group
Bone and joint · Musculoskeletal
Studied dose
5 microg/kg/d · subcutaneous · 18 monthsAs given in this study (cynomolgus monkey).
Measurements
Vertebral ultimate load increase
52%
versus OVX controls
Source sentences
Summary
After the 18-mo treatment period, vertebral BMD, BMC, and strength (ultimate load) were increased by 29%, 36%, and 52%, respectively, compared with OVX controls.
2 context sentences(design, population, supporting numbers)
Summary · context
Ovariectomized (OVX), skeletally mature, cynomolgus monkeys (n = 30 per group) were given teriparatide for 18 mo at either 0 or 5 microg/kg/d subcutaneously.
Summary · context
After 18 mo of treatment, subgroups of six monkeys from both groups were killed and evaluated, whereas all remaining monkeys entered a 3-yr observation period in which they did not receive teriparatide.
Report a problemFND-1868408803
04AnimalAnimal study (in vivo)Efficacy outcome
In ovariectomized monkeys, teriparatide increased proximal femur BMD by 15% versus controls after treatment.
In plain wordsIn monkeys with removed ovaries, teriparatide increased upper thigh bone density by 15% versus controls after treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseProximal femur BMD
Study
cynomolgus monkeyn = 12
Ovariectomized skeletally mature cynomolgus monkeys
Comparator
OVX controls
Outcome group
Bone and joint · Musculoskeletal
Studied dose
5 microg/kg/d · subcutaneous · 18 monthsAs given in this study (cynomolgus monkey).
Measurements
Proximal femur BMD increase
15%
versus OVX controls
Source sentences
Summary
Proximal femur BMD, BMC, and strength were also increased by 15%, 28% and 33%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Ovariectomized (OVX), skeletally mature, cynomolgus monkeys (n = 30 per group) were given teriparatide for 18 mo at either 0 or 5 microg/kg/d subcutaneously.
Summary · context
After 18 mo of treatment, subgroups of six monkeys from both groups were killed and evaluated, whereas all remaining monkeys entered a 3-yr observation period in which they did not receive teriparatide.
Report a problemFND-1868408804
05AnimalAnimal study (in vivo)Efficacy outcome
In ovariectomized monkeys, teriparatide increased proximal femur BMC by 28% versus controls after treatment.
In plain wordsIn monkeys with removed ovaries, teriparatide increased upper thigh bone mineral content by 28% versus controls after treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseProximal femur BMC
Study
cynomolgus monkeyn = 12
Ovariectomized skeletally mature cynomolgus monkeys
Comparator
OVX controls
Outcome group
Bone and joint · Musculoskeletal
Studied dose
5 microg/kg/d · subcutaneous · 18 monthsAs given in this study (cynomolgus monkey).
Measurements
Proximal femur BMC increase
28%
versus OVX controls
Source sentences
Summary
Proximal femur BMD, BMC, and strength were also increased by 15%, 28% and 33%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Ovariectomized (OVX), skeletally mature, cynomolgus monkeys (n = 30 per group) were given teriparatide for 18 mo at either 0 or 5 microg/kg/d subcutaneously.
Summary · context
After 18 mo of treatment, subgroups of six monkeys from both groups were killed and evaluated, whereas all remaining monkeys entered a 3-yr observation period in which they did not receive teriparatide.
Report a problemFND-1868408805
06AnimalAnimal study (in vivo)Efficacy outcome
In ovariectomized monkeys, teriparatide increased proximal femur strength by 33% versus controls after treatment.
In plain wordsIn monkeys with removed ovaries, teriparatide increased upper thigh bone strength by 33% versus controls after treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseProximal femur strength
Study
cynomolgus monkeyn = 12
Ovariectomized skeletally mature cynomolgus monkeys
Comparator
OVX controls
Outcome group
Bone and joint · Musculoskeletal
Studied dose
5 microg/kg/d · subcutaneous · 18 monthsAs given in this study (cynomolgus monkey).
Measurements
Proximal femur strength increase
33%
versus OVX controls
Source sentences
Summary
Proximal femur BMD, BMC, and strength were also increased by 15%, 28% and 33%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Ovariectomized (OVX), skeletally mature, cynomolgus monkeys (n = 30 per group) were given teriparatide for 18 mo at either 0 or 5 microg/kg/d subcutaneously.
Summary · context
After 18 mo of treatment, subgroups of six monkeys from both groups were killed and evaluated, whereas all remaining monkeys entered a 3-yr observation period in which they did not receive teriparatide.
Report a problemFND-1868408806
07AnimalAnimal study (in vivo)Efficacy outcome
In ovariectomized monkeys, vertebral bone mass did not differ from controls after 3 years without teriparatide.
In plain wordsIn monkeys with removed ovaries, spinal bone mass did not differ from controls after 3 years without teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeVertebral bone mass after withdrawal
Study
cynomolgus monkeyn: not reported in source
Ovariectomized skeletally mature cynomolgus monkeys
Comparator
OVX controls
Outcome group
Bone and joint · Musculoskeletal
Studied dose
5 microg/kg/d · subcutaneous · 18 monthsAs given in this study (cynomolgus monkey).
Source sentences
Summary
After 3 yr without treatment, no differences in bone mass or strength at the vertebra were observed relative to OVX controls;
2 context sentences(design, population, supporting numbers)
Summary · context
Ovariectomized (OVX), skeletally mature, cynomolgus monkeys (n = 30 per group) were given teriparatide for 18 mo at either 0 or 5 microg/kg/d subcutaneously.
Summary · context
After 18 mo of treatment, subgroups of six monkeys from both groups were killed and evaluated, whereas all remaining monkeys entered a 3-yr observation period in which they did not receive teriparatide.
Report a problemFND-1868408807
08AnimalAnimal study (in vivo)Efficacy outcome
In ovariectomized monkeys, vertebral strength did not differ from controls after 3 years without teriparatide.
In plain wordsIn monkeys with removed ovaries, spinal bone strength did not differ from controls after 3 years without teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeVertebral strength after withdrawal
Study
cynomolgus monkeyn: not reported in source
Ovariectomized skeletally mature cynomolgus monkeys
Comparator
OVX controls
Outcome group
Bone and joint · Musculoskeletal
Studied dose
5 microg/kg/d · subcutaneous · 18 monthsAs given in this study (cynomolgus monkey).
Source sentences
Summary
After 3 yr without treatment, no differences in bone mass or strength at the vertebra were observed relative to OVX controls;
2 context sentences(design, population, supporting numbers)
Summary · context
Ovariectomized (OVX), skeletally mature, cynomolgus monkeys (n = 30 per group) were given teriparatide for 18 mo at either 0 or 5 microg/kg/d subcutaneously.
Summary · context
After 18 mo of treatment, subgroups of six monkeys from both groups were killed and evaluated, whereas all remaining monkeys entered a 3-yr observation period in which they did not receive teriparatide.
Report a problemFND-1868408808
09AnimalAnimal study (in vivo)Efficacy outcome
In ovariectomized monkeys, femoral neck stiffness remained 20% higher than controls after 3 years without teriparatide.
In plain wordsIn monkeys with removed ovaries, hip stiffness remained 20% higher than controls after 3 years without teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseFemoral neck stiffness after withdrawal
Study
cynomolgus monkeyn: not reported in source
Ovariectomized skeletally mature cynomolgus monkeys
Comparator
OVX controls
Outcome group
Bone and joint · Musculoskeletal
Studied dose
5 microg/kg/d · subcutaneous · 18 monthsAs given in this study (cynomolgus monkey).
Measurements
Femoral neck stiffness difference
20%
3 years after withdrawal versus OVX controls
Source sentences
Summary
however, the femoral neck showed significant persistence in stiffness (20%), BMC (14%), and trabecular BV/TV (53%), indicating a retention of teriparatide efficacy at the hip.
2 context sentences(design, population, supporting numbers)
Summary · context
Ovariectomized (OVX), skeletally mature, cynomolgus monkeys (n = 30 per group) were given teriparatide for 18 mo at either 0 or 5 microg/kg/d subcutaneously.
Summary · context
After 18 mo of treatment, subgroups of six monkeys from both groups were killed and evaluated, whereas all remaining monkeys entered a 3-yr observation period in which they did not receive teriparatide.
Report a problemFND-1868408809
10AnimalAnimal study (in vivo)Efficacy outcome
In ovariectomized monkeys, femoral neck BMC remained 14% higher than controls after 3 years without teriparatide.
In plain wordsIn monkeys with removed ovaries, hip bone mineral content remained 14% higher than controls after 3 years without teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseFemoral neck BMC after withdrawal
Study
cynomolgus monkeyn: not reported in source
Ovariectomized skeletally mature cynomolgus monkeys
Comparator
OVX controls
Outcome group
Bone and joint · Musculoskeletal
Studied dose
5 microg/kg/d · subcutaneous · 18 monthsAs given in this study (cynomolgus monkey).
Measurements
Femoral neck BMC difference
14%
3 years after withdrawal versus OVX controls
Source sentences
Summary
however, the femoral neck showed significant persistence in stiffness (20%), BMC (14%), and trabecular BV/TV (53%), indicating a retention of teriparatide efficacy at the hip.
2 context sentences(design, population, supporting numbers)
Summary · context
Ovariectomized (OVX), skeletally mature, cynomolgus monkeys (n = 30 per group) were given teriparatide for 18 mo at either 0 or 5 microg/kg/d subcutaneously.
Summary · context
After 18 mo of treatment, subgroups of six monkeys from both groups were killed and evaluated, whereas all remaining monkeys entered a 3-yr observation period in which they did not receive teriparatide.
Report a problemFND-1868408810
11AnimalAnimal study (in vivo)Efficacy outcome
In ovariectomized monkeys, femoral neck trabecular BV/TV remained 53% higher than controls after 3 years without teriparatide.
In plain wordsIn monkeys with removed ovaries, hip trabecular bone volume fraction remained 53% higher than controls after 3 years without teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseFemoral neck trabecular BV/TV after withdrawal
Study
cynomolgus monkeyn: not reported in source
Ovariectomized skeletally mature cynomolgus monkeys
Comparator
OVX controls
Outcome group
Bone and joint · Musculoskeletal
Studied dose
5 microg/kg/d · subcutaneous · 18 monthsAs given in this study (cynomolgus monkey).
Measurements
Trabecular BV/TV difference
53%
3 years after withdrawal versus OVX controls
Source sentences
Summary
however, the femoral neck showed significant persistence in stiffness (20%), BMC (14%), and trabecular BV/TV (53%), indicating a retention of teriparatide efficacy at the hip.
2 context sentences(design, population, supporting numbers)
Summary · context
Ovariectomized (OVX), skeletally mature, cynomolgus monkeys (n = 30 per group) were given teriparatide for 18 mo at either 0 or 5 microg/kg/d subcutaneously.
Summary · context
After 18 mo of treatment, subgroups of six monkeys from both groups were killed and evaluated, whereas all remaining monkeys entered a 3-yr observation period in which they did not receive teriparatide.
Report a problemFND-1868408811
12AnimalAnimal study (in vivo)Safety outcome
In ovariectomized monkeys, no bone proliferative lesions were identified after teriparatide treatment or observation.
In plain wordsIn monkeys with removed ovaries, tests found no bone proliferative lesions after teriparatide treatment or observation.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableBone proliferative lesions
Study
cynomolgus monkeyn: not reported in source
Ovariectomized skeletally mature cynomolgus monkeys
Outcome group
Adverse events · Musculoskeletal
Studied dose
5 microg/kg/d · subcutaneous · 18 monthsAs given in this study (cynomolgus monkey).
Source sentences
Summary
Radiographs and histology did not identify any bone proliferative lesions or microscopic lesions of osteosarcoma at the end of the treatment or observation period.
2 context sentences(design, population, supporting numbers)
Summary · context
Ovariectomized (OVX), skeletally mature, cynomolgus monkeys (n = 30 per group) were given teriparatide for 18 mo at either 0 or 5 microg/kg/d subcutaneously.
Summary · context
After 18 mo of treatment, subgroups of six monkeys from both groups were killed and evaluated, whereas all remaining monkeys entered a 3-yr observation period in which they did not receive teriparatide.
Report a problemFND-1868408812
13AnimalAnimal study (in vivo)Safety outcome
In ovariectomized monkeys, no microscopic osteosarcoma lesions were identified after teriparatide treatment or observation.
In plain wordsIn monkeys with removed ovaries, tests found no microscopic bone cancer lesions after teriparatide treatment or observation.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableOsteosarcoma lesions
Study
cynomolgus monkeyn: not reported in source
Ovariectomized skeletally mature cynomolgus monkeys
Outcome group
Adverse events · Musculoskeletal
Studied dose
5 microg/kg/d · subcutaneous · 18 monthsAs given in this study (cynomolgus monkey).
Source sentences
Summary
Radiographs and histology did not identify any bone proliferative lesions or microscopic lesions of osteosarcoma at the end of the treatment or observation period.
2 context sentences(design, population, supporting numbers)
Summary · context
Ovariectomized (OVX), skeletally mature, cynomolgus monkeys (n = 30 per group) were given teriparatide for 18 mo at either 0 or 5 microg/kg/d subcutaneously.
Summary · context
After 18 mo of treatment, subgroups of six monkeys from both groups were killed and evaluated, whereas all remaining monkeys entered a 3-yr observation period in which they did not receive teriparatide.
Report a problemFND-1868408813

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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.

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MeSH terms

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