Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation.

Yamamoto T, Tsujimoto M, Sowa H

Clinical interventions in aging6 Jul 2015Cited by 2 (Europe PMC)

PMID26185429PMCIDPMC4500620DOI10.2147/cia.s83549PepBankPUB-26185429

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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 study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialSafety outcome
In Japanese patients with osteoporosis, serum calcium remained within the normal range during teriparatide treatment, as in the placebo group.
In plain wordsIn patients with osteoporosis, blood calcium stayed within the normal range during teriparatide treatment, as in the placebo group.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableSerum calcium within normal range
Study
n: not reported in source
Outcome group
Adverse events · Endocrine and hormones
Studied dose
20 μg/day · 12 monthsAs given in this study (human).
Source sentences
Summary
Serum calcium concentration in both the teriparatide and placebo groups remained within the normal range.
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese subjects with osteoporosis at high risk of fracture were randomized 2:1 to teriparatide 20 μg/day (n=137) or placebo (n=70) for a 12-month double-blind treatment period, followed by 12 months of open-label teriparatide treatment of all subjects.
Report a problemFND-2618542903
02HumanNon-randomized trialActivity measurement
During teriparatide treatment, 28 of 195 subjects had PINP elevations above 200 μg/L.
In plain wordsDuring teriparatide treatment, 28 of 195 subjects had PINP levels above 200 μg/L.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicablePINP elevations above threshold
Study
n = 195
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg/day · 24 monthsAs given in this study (human).
Measurements
Subjects with PINP elevation >200 μg/L
28 subjects
during teriparatide treatment
Source sentences
Summary
Twenty-eight of 195 subjects experienced PINP elevations >200 μg/L during teriparatide treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese subjects with osteoporosis at high risk of fracture were randomized 2:1 to teriparatide 20 μg/day (n=137) or placebo (n=70) for a 12-month double-blind treatment period, followed by 12 months of open-label teriparatide treatment of all subjects.
Report a problemFND-2618542902
03HumanNon-randomized trialActivity measurement
In Japanese patients with osteoporosis, serum PINP increased after teriparatide treatment and remained elevated through 24 months.
In plain wordsIn patients with osteoporosis, serum PINP increased during teriparatide treatment compared with baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseSerum PINP over time
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg/day · 24 monthsAs given in this study (human).
Source sentences
Summary
Serum PINP increased from baseline to 1 month of treatment and then remained high through 24 months.
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese subjects with osteoporosis at high risk of fracture were randomized 2:1 to teriparatide 20 μg/day (n=137) or placebo (n=70) for a 12-month double-blind treatment period, followed by 12 months of open-label teriparatide treatment of all subjects.
Report a problemFND-2618542901
04HumanNon-randomized trialSafety outcome
Two subjects developed hypercalcemia and recovered without a change in teriparatide treatment.
In plain wordsTwo subjects developed high blood calcium and recovered without a change in teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableHypercalcemia
Study
n: not reported in source
Outcome group
Adverse events · Endocrine and hormones
Studied dose
20 μg/day · 24 monthsAs given in this study (human).
Measurements
Subjects with hypercalcemia
2 subjects
teriparatide study
Source sentences
Summary
Two subjects experienced hypercalcemia and recovered without altering teriparatide treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese subjects with osteoporosis at high risk of fracture were randomized 2:1 to teriparatide 20 μg/day (n=137) or placebo (n=70) for a 12-month double-blind treatment period, followed by 12 months of open-label teriparatide treatment of all subjects.
Report a problemFND-2618542904
05HumanNon-randomized trialSafety outcome
During the osteoporosis study, one subject experienced periarthritis calcarea without a significant increase in PINP or serum calcium.
In plain wordsOne subject experienced periarthritis calcarea without a significant increase in PINP or blood calcium.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicablePeriarthritis calcarea
Study
n: not reported in source
Outcome group
Adverse events · Musculoskeletal
Studied dose
20 μg/day · 24 monthsAs given in this study (human).
Measurements
Subjects with periarthritis calcarea
1 subjects
teriparatide study
Source sentences
Summary
Adverse events possibly related to calcium metabolism disorders included periarthritis calcarea (one subject) and chondrocalcinosis pyrophosphate (two subjects), but neither was accompanied with a significant increase in PINP or serum calcium concentration.
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese subjects with osteoporosis at high risk of fracture were randomized 2:1 to teriparatide 20 μg/day (n=137) or placebo (n=70) for a 12-month double-blind treatment period, followed by 12 months of open-label teriparatide treatment of all subjects.
Report a problemFND-2618542905
06HumanNon-randomized trialSafety outcome
During the osteoporosis study, two subjects experienced chondrocalcinosis pyrophosphate without a significant increase in PINP or serum calcium.
In plain wordsTwo subjects experienced chondrocalcinosis pyrophosphate without a significant increase in PINP or blood calcium.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableChondrocalcinosis pyrophosphate
Study
n: not reported in source
Outcome group
Adverse events · Musculoskeletal
Studied dose
20 μg/day · 24 monthsAs given in this study (human).
Measurements
Subjects with chondrocalcinosis pyrophosphate
2 subjects
teriparatide study
Source sentences
Summary
Adverse events possibly related to calcium metabolism disorders included periarthritis calcarea (one subject) and chondrocalcinosis pyrophosphate (two subjects), but neither was accompanied with a significant increase in PINP or serum calcium concentration.
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese subjects with osteoporosis at high risk of fracture were randomized 2:1 to teriparatide 20 μg/day (n=137) or placebo (n=70) for a 12-month double-blind treatment period, followed by 12 months of open-label teriparatide treatment of all subjects.
Report a problemFND-2618542906

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00433160

Phase 3 Clinical Trial of Teriparatide in Japan

Eli Lilly and Companyn = 207Jan 2007 to Sept 2009

Osteoporosis

Trial page ClinicalTrials.govUpdated 21 Sept 2010

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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