Safety and effectiveness of daily teriparatide in a prospective observational study in patients with osteoporosis at high risk of fracture in Japan: final report.

Nishikawa A, Ishida T, Taketsuna M, Yoshiki F, Enomoto H

Clinical interventions in aging6 Jul 2016Cited by 32 (Europe PMC)

PMID27462147PMCIDPMC4939987DOI10.2147/cia.s107285PepBankPUB-27462147

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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study16

16 results from studies that gave the peptide. 16 results from people.

01HumanObservational studySafety outcome
In Japanese patients with osteoporosis, 140 patients reported 157 adverse drug reactions during teriparatide treatment.
In plain wordsIn Japanese patients with osteoporosis, adverse drug reactions occurred during teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableAdverse drug reactions
Study
n = 1,847
Outcome group
Adverse events · Whole body
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Measurements
Patients with ADRs
7.58%
teriparatide
Patients with ADRs
140 patients
teriparatide
Adverse drug reactions reported
157 ADRs
teriparatide
Source sentences
Summary
A total of 157 adverse drug reactions (ADRs) were reported in 140 (7.58%) patients; the most common ADRs were hyperuricemia, nausea, and dizziness.
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214701
02HumanObservational studySafety outcome
In Japanese patients with osteoporosis, hyperuricemia was among the most common adverse reactions to teriparatide.
In plain wordsIn Japanese patients with osteoporosis, high uric acid was among the common adverse reactions to teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableHyperuricemia
Study
n = 1,847
Outcome group
Adverse events · Metabolic and weight
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Source sentences
Summary
A total of 157 adverse drug reactions (ADRs) were reported in 140 (7.58%) patients; the most common ADRs were hyperuricemia, nausea, and dizziness.
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214702
03HumanObservational studySafety outcome
In Japanese patients with osteoporosis, nausea was among the most common adverse reactions to teriparatide.
In plain wordsIn Japanese patients with osteoporosis, nausea was among the common adverse reactions to teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableNausea
Study
n = 1,847
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Source sentences
Summary
A total of 157 adverse drug reactions (ADRs) were reported in 140 (7.58%) patients; the most common ADRs were hyperuricemia, nausea, and dizziness.
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214703
04HumanObservational studySafety outcome
In Japanese patients with osteoporosis, dizziness was among the most common adverse reactions to teriparatide.
In plain wordsIn Japanese patients with osteoporosis, dizziness was among the common adverse reactions to teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableDizziness
Study
n = 1,847
Outcome group
Adverse events · Nervous system and cognition
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Source sentences
Summary
A total of 157 adverse drug reactions (ADRs) were reported in 140 (7.58%) patients; the most common ADRs were hyperuricemia, nausea, and dizziness.
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214704
05HumanObservational studySafety outcome
In Japanese patients with osteoporosis, six patients reported serious adverse reactions during teriparatide treatment.
In plain wordsIn Japanese patients with osteoporosis, serious adverse reactions occurred during teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableSerious adverse drug reactions
Study
n = 1,847
Outcome group
Adverse events · Whole body
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Measurements
Serious ADRs
0.32%
patients
Source sentences
Summary
Only six (0.32%) patients reported serious ADRs, the most common being nausea (two patients; 0.1%).
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214705
06HumanObservational studySafety outcome
In Japanese patients with osteoporosis, two patients reported nausea as a serious adverse reaction during teriparatide treatment.
In plain wordsIn Japanese patients with osteoporosis, nausea occurred as a serious adverse reaction during teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableSerious nausea
Study
n = 1,847
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Measurements
Serious nausea
0.1%
patients
Source sentences
Summary
Only six (0.32%) patients reported serious ADRs, the most common being nausea (two patients; 0.1%).
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214706
07HumanObservational studyOther
In Japanese patients with osteoporosis, teriparatide persistence was 60.8% at 18 months and 39.1% at 24 months.
In plain wordsIn Japanese patients with osteoporosis, fewer patients continued teriparatide at the later observation.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableTreatment persistence
Study
n = 1,847
Outcome group
Treatment adherence and retention · Whole body
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Measurements
Treatment persistence
60.8%
at 18 months
Treatment persistence
39.1%
at 24 months
Source sentences
Summary
Persistence with teriparatide treatment was 60.8% and 39.1% at 18 and 24 months, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214707
08HumanObservational studyEfficacy outcome
In Japanese patients with osteoporosis, procollagen type I N-terminal propeptide increased during teriparatide treatment.
In plain wordsIn Japanese patients with osteoporosis, this bone formation marker increased during teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseProcollagen type I N-terminal propeptide
Study
n = 1,847
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Source sentences
Summary
There were significant increases in biomarkers for bone formation (procollagen type I N-terminal propeptide and bone-specific alkaline phosphatase) and bone resorption (collagen type I cross-linked C telopeptide and tartrate-resistant acid phosphatase 5b) throughout the study.
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214708
09HumanObservational studyEfficacy outcome
In Japanese patients with osteoporosis, bone-specific alkaline phosphatase increased during teriparatide treatment.
In plain wordsIn Japanese patients with osteoporosis, bone alkaline phosphatase increased during teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseBone-specific alkaline phosphatase
Study
n = 1,847
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Source sentences
Summary
There were significant increases in biomarkers for bone formation (procollagen type I N-terminal propeptide and bone-specific alkaline phosphatase) and bone resorption (collagen type I cross-linked C telopeptide and tartrate-resistant acid phosphatase 5b) throughout the study.
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214709
10HumanObservational studyEfficacy outcome
In Japanese patients with osteoporosis, collagen type I cross-linked C telopeptide increased during teriparatide treatment.
In plain wordsIn Japanese patients with osteoporosis, this bone breakdown marker increased during teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseCollagen type I cross-linked C telopeptide
Study
n = 1,847
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Source sentences
Summary
There were significant increases in biomarkers for bone formation (procollagen type I N-terminal propeptide and bone-specific alkaline phosphatase) and bone resorption (collagen type I cross-linked C telopeptide and tartrate-resistant acid phosphatase 5b) throughout the study.
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214710
11HumanObservational studyEfficacy outcome
In Japanese patients with osteoporosis, tartrate-resistant acid phosphatase 5b increased during teriparatide treatment.
In plain wordsIn Japanese patients with osteoporosis, this bone breakdown marker increased during teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseTartrate-resistant acid phosphatase 5b
Study
n = 1,847
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Source sentences
Summary
There were significant increases in biomarkers for bone formation (procollagen type I N-terminal propeptide and bone-specific alkaline phosphatase) and bone resorption (collagen type I cross-linked C telopeptide and tartrate-resistant acid phosphatase 5b) throughout the study.
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214711
12HumanObservational studyEfficacy outcome
In Japanese patients with osteoporosis, BMD increased significantly during teriparatide treatment.
In plain wordsIn Japanese patients with osteoporosis, bone density increased during teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseBone mineral density
Study
n = 1,847
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Source sentences
Summary
These were accompanied by significant increases in bone mineral density and low incidences of new vertebral and nonvertebral fractures.
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214712
13HumanObservational studyEfficacy outcome
In Japanese patients with osteoporosis, new vertebral fracture incidence was low during teriparatide treatment.
In plain wordsIn Japanese patients with osteoporosis, new vertebral fractures had a low incidence during teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableNew vertebral fractures
Study
n = 1,847
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Source sentences
Summary
These were accompanied by significant increases in bone mineral density and low incidences of new vertebral and nonvertebral fractures.
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214713
14HumanObservational studyEfficacy outcome
In Japanese patients with osteoporosis, new nonvertebral fracture incidence was low during teriparatide treatment.
In plain wordsIn Japanese patients with osteoporosis, new fractures outside the spine had a low incidence during teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableNew nonvertebral fractures
Study
n = 1,847
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Source sentences
Summary
These were accompanied by significant increases in bone mineral density and low incidences of new vertebral and nonvertebral fractures.
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214714
15HumanObservational studyEfficacy outcome
In Japanese patients with osteoporosis, back pain improved significantly from baseline during teriparatide treatment.
In plain wordsIn Japanese patients with osteoporosis, teriparatide treatment was linked to less back pain than at baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
DecreaseBack pain
Study
n = 1,847
Comparator
Baseline
Outcome group
Pain · Musculoskeletal
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Source sentences
Summary
Patient-reported measurements for health-related quality of life revealed significant improvements from baseline in back pain and overall health-related quality of life (Short Form-8™ health survey).
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214715
16HumanObservational studyEfficacy outcome
In Japanese patients with osteoporosis, overall health-related quality of life improved significantly from baseline during teriparatide treatment.
In plain wordsIn Japanese patients with osteoporosis, teriparatide treatment was linked to better quality of life than at baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseHealth-related quality of life
Study
n = 1,847
Comparator
Baseline
Outcome group
Quality of life · Whole body
Studied dose
20 μg daily · subcutaneous · maximum 24 monthsAs given in this study (human).
Source sentences
Summary
Patient-reported measurements for health-related quality of life revealed significant improvements from baseline in back pain and overall health-related quality of life (Short Form-8™ health survey).
3 context sentences(design, population, supporting numbers)
Summary · context
This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan.
Summary · context
The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months.
Summary · context
Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years.
Report a problemFND-2746214716

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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

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Safety and effectiveness of daily teriparatide in a prospective observational study in patients with osteoporosis at high risk of fracture in Japan: final report.

Summary

Results from this study16

Version history

Subjects

Publication types

MeSH terms

Keywords