Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases.

Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T

Bone24 May 2010Cited by 120 (Europe PMC)

PMID20580870DOI10.1016/j.bone.2010.05.022PepBankPUB-20580870

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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 study16

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

01HumanRandomized controlled trialEfficacy outcome
In Japanese patients with osteoporosis, teriparatide increased lumbar spine BMD more than placebo at 12 months.
In plain wordsIn Japanese patients with osteoporosis, teriparatide increased spine bone density more than placebo.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseLumbar spine BMD at 12 months
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 microg/day · 12 monthsAs given in this study (human).
Measurements
Lumbar spine BMD change
10.04%
teriparatide at 12 months
Lumbar spine BMD change
0.19%
placebo at 12 months
Source sentences
Summary
For subjects with measurements at 12 months, teriparatide significantly increased bone mineral density (BMD) at the lumbar spine L2-L4 (mean percent change+/-SD, teriparatide 10.04+/-5.23% versus placebo-teriparatide 0.19+/-4.33%)
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087001
02HumanRandomized controlled trialEfficacy outcome
In Japanese patients with osteoporosis, teriparatide increased femoral neck BMD more than placebo at 12 months.
In plain wordsIn Japanese patients with osteoporosis, teriparatide increased femoral neck bone density more than placebo.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseFemoral neck BMD at 12 months
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 microg/day · 12 monthsAs given in this study (human).
Measurements
Femoral neck BMD change
2.01%
teriparatide at 12 months
Femoral neck BMD change
0.44%
placebo at 12 months
Source sentences
Summary
the femoral neck (teriparatide 2.01+/-4.63% versus placebo-teriparatide 0.44+/-3.97%)
2 context sentences(design, population, supporting numbers)
Summary · context
For subjects with measurements at 12 months, teriparatide significantly increased bone mineral density (BMD)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087002
03HumanRandomized controlled trialEfficacy outcome
In Japanese patients with osteoporosis, teriparatide increased total hip BMD more than placebo at 12 months.
In plain wordsIn Japanese patients with osteoporosis, teriparatide increased total hip bone density more than placebo.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseTotal hip BMD at 12 months
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 microg/day · 12 monthsAs given in this study (human).
Measurements
Total hip BMD change
2.72%
teriparatide at 12 months
Total hip BMD change
−0.26%
placebo at 12 months
Source sentences
Summary
and the total hip (teriparatide 2.72+/-4.04% versus placebo-teriparatide -0.26+/-3.42%).
2 context sentences(design, population, supporting numbers)
Summary · context
For subjects with measurements at 12 months, teriparatide significantly increased bone mineral density (BMD)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087003
04HumanRandomized controlled trialEfficacy outcome
In Japanese patients with osteoporosis, teriparatide increased PINP more than placebo at 1 month.
In plain wordsIn Japanese patients with osteoporosis, teriparatide increased a bone formation marker more than placebo at 1 month.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreasePINP at 1 month
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 microg/day · 1 monthAs given in this study (human).
Source sentences
Summary
Serum procollagen I N-terminal pro-peptide (PINP) increased rapidly with teriparatide treatment (P<0.001 versus placebo at 1 month)
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087010
05HumanRandomized controlled trialEfficacy outcome
In Japanese patients with osteoporosis, PINP changed by 78.95% with teriparatide versus -17.23% with placebo at 12 months.
In plain wordsIn Japanese patients with osteoporosis, teriparatide increased the bone formation marker PINP more than placebo at 12 months.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreasePINP at 12 months
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 microg/day · 12 monthsAs given in this study (human).
Measurements
Median PINP change
78.95%
teriparatide at 12 months
Median PINP change
−17.23%
placebo at 12 months
Source sentences
Summary
and changed from baseline in the teriparatide and placebo-teriparatide groups at 12 months by a median of 78.95% and -17.23%, respectively, (P<0.001)
2 context sentences(design, population, supporting numbers)
Summary · context
Serum procollagen I N-terminal pro-peptide (PINP)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087011
06HumanRandomized controlled trialSafety outcome
In Japanese patients with osteoporosis, treatment-emergent adverse event incidence was comparable between teriparatide and placebo-teriparatide groups.
In plain wordsIn Japanese patients with osteoporosis, adverse event rates were similar between teriparatide and placebo-teriparatide groups.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeTreatment-emergent adverse events
Study
n: not reported in source
Comparator
Placebo-teriparatide group
Outcome group
Adverse events · Whole body
Studied dose
20 microg/dayAs given in this study (human).
Source sentences
Summary
The incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuations due to TEAEs were comparable in the teriparatide and placebo-teriparatide groups.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087014
07HumanRandomized controlled trialSafety outcome
In Japanese patients with osteoporosis, serious treatment-emergent adverse event incidence was comparable between teriparatide and placebo-teriparatide groups.
In plain wordsIn Japanese patients with osteoporosis, serious adverse event rates were similar between teriparatide and placebo-teriparatide groups.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeSerious treatment-emergent adverse events
Study
n: not reported in source
Comparator
Placebo-teriparatide group
Outcome group
Adverse events · Whole body
Studied dose
20 microg/dayAs given in this study (human).
Source sentences
Summary
The incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuations due to TEAEs were comparable in the teriparatide and placebo-teriparatide groups.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087015
08HumanRandomized controlled trialSafety outcome
In Japanese patients with osteoporosis, adverse-event discontinuations were comparable between teriparatide and placebo-teriparatide groups.
In plain wordsIn Japanese patients with osteoporosis, discontinuations due to adverse events were similar between teriparatide and placebo-teriparatide groups.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeDiscontinuations due to adverse events
Study
n: not reported in source
Comparator
Placebo-teriparatide group
Outcome group
Adverse events · Whole body
Studied dose
20 microg/dayAs given in this study (human).
Source sentences
Summary
The incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuations due to TEAEs were comparable in the teriparatide and placebo-teriparatide groups.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087016
09HumanNon-randomized trialEfficacy outcome
In Japanese patients switched from placebo, lumbar spine BMD increased by 9.11% after 12 months of teriparatide.
In plain wordsIn Japanese patients switched from placebo, spine bone density increased during teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseLumbar spine BMD after placebo switch
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 microg/day · 12 monthsAs given in this study (human).
Measurements
Lumbar spine BMD increase
9.11%
placebo-teriparatide group at 24 months
Source sentences
Summary
In the placebo-teriparatide group at 24 months (12-month teriparatide dosing) BMD increased by 9.11+/-5.14% at the lumbar spine, 2.19+/-4.81% at the femoral neck and 2.46+/-3.54% at the total hip.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087004
10HumanNon-randomized trialEfficacy outcome
In Japanese patients switched from placebo, femoral neck BMD increased by 2.19% after 12 months of teriparatide.
In plain wordsIn Japanese patients switched from placebo, femoral neck bone density increased during teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseFemoral neck BMD after placebo switch
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 microg/day · 12 monthsAs given in this study (human).
Measurements
Femoral neck BMD increase
2.19%
placebo-teriparatide group at 24 months
Source sentences
Summary
In the placebo-teriparatide group at 24 months (12-month teriparatide dosing) BMD increased by 9.11+/-5.14% at the lumbar spine, 2.19+/-4.81% at the femoral neck and 2.46+/-3.54% at the total hip.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087005
11HumanNon-randomized trialEfficacy outcome
In Japanese patients switched from placebo, total hip BMD increased by 2.46% after 12 months of teriparatide.
In plain wordsIn Japanese patients switched from placebo, total hip bone density increased during teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseTotal hip BMD after placebo switch
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 microg/day · 12 monthsAs given in this study (human).
Measurements
Total hip BMD increase
2.46%
placebo-teriparatide group at 24 months
Source sentences
Summary
In the placebo-teriparatide group at 24 months (12-month teriparatide dosing) BMD increased by 9.11+/-5.14% at the lumbar spine, 2.19+/-4.81% at the femoral neck and 2.46+/-3.54% at the total hip.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087006
12HumanNon-randomized trialEfficacy outcome
In Japanese patients continuing teriparatide, lumbar spine BMD increased by 11.93% and 13.42% at 18 and 24 months, respectively.
In plain wordsIn Japanese patients continuing teriparatide, spine bone density increased from baseline at both follow-up assessments.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseLumbar spine BMD at 18 and 24 months
Study
n: not reported in source
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 microg/day · 18 and 24 monthsAs given in this study (human).
Measurements
Lumbar spine BMD increase
11.93%
18 months
Lumbar spine BMD increase
13.42%
24 months
Source sentences
Summary
In the teriparatide group at 18 and 24 months, BMD increased from baseline at the lumbar spine by 11.93+/-5.79% and 13.42+/-6.12%, respectively; at the femoral neck by 2.68+/-4.45% and 3.26+/-4.25%, respectively; and at the total hip by 3.02+/-3.79% and 3.67+/-3.98%, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087007
13HumanNon-randomized trialEfficacy outcome
In Japanese patients continuing teriparatide, femoral neck BMD increased by 2.68% and 3.26% at 18 and 24 months, respectively.
In plain wordsIn Japanese patients continuing teriparatide, femoral neck bone density increased from baseline at both follow-up assessments.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseFemoral neck BMD at 18 and 24 months
Study
n: not reported in source
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 microg/day · 18 and 24 monthsAs given in this study (human).
Measurements
Femoral neck BMD increase
2.68%
18 months
Femoral neck BMD increase
3.26%
24 months
Source sentences
Summary
In the teriparatide group at 18 and 24 months, BMD increased from baseline at the lumbar spine by 11.93+/-5.79% and 13.42+/-6.12%, respectively; at the femoral neck by 2.68+/-4.45% and 3.26+/-4.25%, respectively; and at the total hip by 3.02+/-3.79% and 3.67+/-3.98%, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087008
14HumanNon-randomized trialEfficacy outcome
In Japanese patients continuing teriparatide, total hip BMD increased by 3.02% and 3.67% at 18 and 24 months, respectively.
In plain wordsIn Japanese patients continuing teriparatide, total hip bone density increased from baseline at both follow-up assessments.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseTotal hip BMD at 18 and 24 months
Study
n: not reported in source
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 microg/day · 18 and 24 monthsAs given in this study (human).
Measurements
Total hip BMD increase
3.02%
18 months
Total hip BMD increase
3.67%
24 months
Source sentences
Summary
In the teriparatide group at 18 and 24 months, BMD increased from baseline at the lumbar spine by 11.93+/-5.79% and 13.42+/-6.12%, respectively; at the femoral neck by 2.68+/-4.45% and 3.26+/-4.25%, respectively; and at the total hip by 3.02+/-3.79% and 3.67+/-3.98%, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087009
15HumanNon-randomized trialEfficacy outcome
In Japanese patients continuing teriparatide, median PINP increased by 49.24% from baseline at 24 months.
In plain wordsIn Japanese patients continuing teriparatide, PINP increased from baseline at 24 months.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreasePINP at 24 months with continuous treatment
Study
n: not reported in source
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 microg/day · 24 monthsAs given in this study (human).
Measurements
Median PINP change
49.24%
teriparatide at 24 months
Source sentences
Summary
and changed from baseline in the teriparatide and placebo-teriparatide groups at 12 months by a median of 78.95% and -17.23%, respectively, (P<0.001) and at 24 months by 49.24% and 76.12%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Serum procollagen I N-terminal pro-peptide (PINP)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087012
16HumanNon-randomized trialEfficacy outcome
In Japanese patients switched from placebo to teriparatide, median PINP increased by 76.12% from baseline at 24 months.
In plain wordsIn Japanese patients switched from placebo to teriparatide, PINP increased from baseline at 24 months.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreasePINP at 24 months after placebo switch
Study
n: not reported in source
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 microg/day · 12 monthsAs given in this study (human).
Measurements
Median PINP change
76.12%
placebo-teriparatide at 24 months
Source sentences
Summary
and changed from baseline in the teriparatide and placebo-teriparatide groups at 12 months by a median of 78.95% and -17.23%, respectively, (P<0.001) and at 24 months by 49.24% and 76.12%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Serum procollagen I N-terminal pro-peptide (PINP)
Summary · context
This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 mon…
Report a problemFND-2058087013

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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MeSH terms

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