Teriparatide for idiopathic osteoporosis in premenopausal women: a pilot study.

Cohen A, Stein EM, Recker RR, Lappe JM, Dempster DW, Zhou H, Cremers S, McMahon DJ, Nickolas TL, Müller R, Zwahlen A, Young P, Stubby J, Shane E

The Journal of clinical endocrinology and metabolism29 Mar 2013Cited by 69 (Europe PMC)

PMID23543660PMCIDPMC3644608DOI10.1210/jc.2013-1172PepBankPUB-23543660

Source link PubMedAsk about this study

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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 study17

15 results from studies that gave the peptide. 15 results from people.

01HumanNon-randomized trialEfficacy outcome
In premenopausal women with idiopathic osteoporosis, teriparatide increased spine BMD from baseline.
In plain wordsIn premenopausal women with idiopathic osteoporosis, teriparatide increased spine bone density compared with baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseSpine BMD
Study
n = 21
Comparator
Baseline
Analysis
Primary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Measurements
Spine BMD increase
10.8%
mean
Spine BMD increase SD
8.3%
SD
Source sentences
Summary
BMD increased at the spine (10.8 ± 8.3% [SD]), total hip (6.2 ± 5.6%), and femoral neck (7.6 ± 3.4%) (all P < .001).
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366001
02HumanNon-randomized trialEfficacy outcome
In premenopausal women with idiopathic osteoporosis, teriparatide increased total hip BMD from baseline.
In plain wordsIn premenopausal women with idiopathic osteoporosis, teriparatide increased total hip bone density compared with baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseTotal hip BMD
Study
n = 21
Comparator
Baseline
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Measurements
Total hip BMD increase
6.2%
mean
Total hip BMD increase SD
5.6%
SD
Source sentences
Summary
BMD increased at the spine (10.8 ± 8.3% [SD]), total hip (6.2 ± 5.6%), and femoral neck (7.6 ± 3.4%) (all P < .001).
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366002
03HumanNon-randomized trialEfficacy outcome
In premenopausal women with idiopathic osteoporosis, teriparatide increased femoral neck BMD from baseline.
In plain wordsIn premenopausal women with idiopathic osteoporosis, teriparatide increased femoral neck bone density compared with baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseFemoral neck BMD
Study
n = 21
Comparator
Baseline
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Measurements
Femoral neck BMD increase
7.6%
mean
Femoral neck BMD increase SD
3.4%
SD
Source sentences
Summary
BMD increased at the spine (10.8 ± 8.3% [SD]), total hip (6.2 ± 5.6%), and femoral neck (7.6 ± 3.4%) (all P < .001).
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366003
04HumanNon-randomized trialEfficacy outcome
In premenopausal women, serum P1NP doubled early during teriparatide, peaked later, and returned to baseline by treatment end.
In plain wordsIn premenopausal women, a bone formation marker rose during teriparatide treatment and later returned to baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
MixedSerum P1NP trajectory
Study
n = 21
Comparator
Baseline
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Source sentences
Summary
Serum P1NP doubled by 1 month, peaked at 6 months, and returned to baseline by 18 to 24 months.
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366004
05HumanNon-randomized trialEfficacy outcome
In premenopausal women with idiopathic osteoporosis, teriparatide increased cortical width from baseline.
In plain wordsIn premenopausal women with idiopathic osteoporosis, teriparatide increased cortical bone width compared with baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseCortical width
Study
n = 21
Comparator
Baseline
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Source sentences
Summary
Transiliac biopsies demonstrated significant increases in cortical width and porosity and trabecular bone volume and number increased, mirrored by a 71% increase in trabecular bone stiffness (P < .02-.001).
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366005
06HumanNon-randomized trialEfficacy outcome
In premenopausal women with idiopathic osteoporosis, teriparatide increased cortical porosity from baseline.
In plain wordsIn premenopausal women with idiopathic osteoporosis, teriparatide increased cortical bone porosity compared with baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseCortical porosity
Study
n = 21
Comparator
Baseline
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Source sentences
Summary
Transiliac biopsies demonstrated significant increases in cortical width and porosity and trabecular bone volume and number increased, mirrored by a 71% increase in trabecular bone stiffness (P < .02-.001).
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366006
07HumanNon-randomized trialEfficacy outcome
In premenopausal women with idiopathic osteoporosis, teriparatide increased trabecular bone volume from baseline.
In plain wordsIn premenopausal women with idiopathic osteoporosis, teriparatide increased trabecular bone volume compared with baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseTrabecular bone volume
Study
n = 21
Comparator
Baseline
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Source sentences
Summary
Transiliac biopsies demonstrated significant increases in cortical width and porosity and trabecular bone volume and number increased, mirrored by a 71% increase in trabecular bone stiffness (P < .02-.001).
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366007
08HumanNon-randomized trialEfficacy outcome
In premenopausal women with idiopathic osteoporosis, teriparatide increased trabecular number from baseline.
In plain wordsIn premenopausal women with idiopathic osteoporosis, teriparatide increased the number of bone trabeculae compared with baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseTrabecular number
Study
n = 21
Comparator
Baseline
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Source sentences
Summary
Transiliac biopsies demonstrated significant increases in cortical width and porosity and trabecular bone volume and number increased, mirrored by a 71% increase in trabecular bone stiffness (P < .02-.001).
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366008
09HumanNon-randomized trialEfficacy outcome
In premenopausal women with idiopathic osteoporosis, teriparatide increased trabecular stiffness from baseline.
In plain wordsIn premenopausal women with idiopathic osteoporosis, teriparatide increased trabecular bone stiffness compared with baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseTrabecular stiffness
Study
n = 21
Comparator
Baseline
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Measurements
Trabecular stiffness increase
71%
versus baseline
Source sentences
Summary
Transiliac biopsies demonstrated significant increases in cortical width and porosity and trabecular bone volume and number increased, mirrored by a 71% increase in trabecular bone stiffness (P < .02-.001).
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366009
10HumanNon-randomized trialEfficacy outcome
In premenopausal women with idiopathic osteoporosis, adipocyte area decreased during teriparatide treatment.
In plain wordsIn premenopausal women, bone marrow fat cell area decreased during teriparatide treatment compared with baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
DecreaseAdipocyte area
Study
n = 21
Comparator
Baseline
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Source sentences
Summary
Adipocyte area, perimeter, and volume/marrow volume decreased, with no change in adipocyte number.
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366010
11HumanNon-randomized trialEfficacy outcome
In premenopausal women with idiopathic osteoporosis, adipocyte perimeter decreased during teriparatide treatment.
In plain wordsIn premenopausal women, bone marrow fat cell perimeter decreased during teriparatide treatment compared with baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
DecreaseAdipocyte perimeter
Study
n = 21
Comparator
Baseline
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Source sentences
Summary
Adipocyte area, perimeter, and volume/marrow volume decreased, with no change in adipocyte number.
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366011
12HumanNon-randomized trialEfficacy outcome
In premenopausal women with idiopathic osteoporosis, adipocyte volume relative to marrow volume decreased during teriparatide treatment.
In plain wordsIn premenopausal women, the marrow fat cell volume ratio decreased during teriparatide treatment compared with baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
DecreaseAdipocyte volume/marrow volume
Study
n = 21
Comparator
Baseline
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Source sentences
Summary
Adipocyte area, perimeter, and volume/marrow volume decreased, with no change in adipocyte number.
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366012
13HumanNon-randomized trialEfficacy outcome
In premenopausal women with idiopathic osteoporosis, adipocyte number did not change during teriparatide treatment.
In plain wordsIn premenopausal women, marrow fat cell number did not change during teriparatide treatment compared with baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeAdipocyte number
Study
n = 21
Comparator
Baseline
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Source sentences
Summary
Adipocyte area, perimeter, and volume/marrow volume decreased, with no change in adipocyte number.
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366013
14HumanNon-randomized trialEfficacy outcome
Four premenopausal women without BMD improvement had a blunted, delayed P1NP increase during teriparatide treatment.
In plain wordsFour premenopausal women without bone density improvement had a small, delayed bone marker increase during teriparatide treatment.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseP1NP response in nonresponders
Study
n = 4
Comparator
Baseline
Analysis
Secondary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Source sentences
Summary
Four women had no increase in BMD and a blunted, delayed increase in serum P1NP.
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366015
15HumanNon-randomized trialEfficacy outcome
Four of 21 premenopausal women with idiopathic osteoporosis had no BMD increase during teriparatide treatment.
In plain wordsFour of 21 premenopausal women had no bone density increase during teriparatide treatment compared with baseline.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeBMD nonresponse
Study
n = 21
Comparator
Baseline
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg daily · 18 to 24 monthsAs given in this study (human).
Measurements
Women with no BMD increase
4 women
teriparatide-treated women
Source sentences
Summary
Four women had no increase in BMD and a blunted, delayed increase in serum P1NP.
3 context sentences(design, population, supporting numbers)
Summary · context
This was an open-label pilot study.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.
Summary · context
Teriparatide was administered at 20 μg daily for 18 to 24 months.
Report a problemFND-2354366014

Studies that did not test the peptide alone2

In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Teriparatide (PTH 1-34).

16HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyOther
Among teriparatide-treated premenopausal women, BMD nonresponders had lower baseline bone formation rates than responders.
In plain wordsAmong women receiving teriparatide, those without bone density improvement had lower bone formation rates before treatment than responders.
Peptide
Teriparatide (PTH 1-34)
Outcome
DecreaseBaseline bone formation rate and BMD nonresponse
Study
n = 21
Comparator
BMD responders
Outcome group
Bone and joint · Musculoskeletal
Measurements
Baseline bone formation rate
0.002 mm²/mm/y
BMD nonresponders
Baseline bone formation rate SD
0.001 mm²/mm/y
BMD nonresponders SD
Baseline bone formation rate
0.011 mm²/mm/y
BMD responders
Baseline bone formation rate SD
0.006 mm²/mm/y
BMD responders SD
Source sentences
Summary
Nonresponders had markedly lower baseline bone formation rate (0.002 ± 0.001 vs 0.011 ± 0.006 mm²/mm/y; P < .001) and higher serum IGF-1 (208 ± 54 vs 157± 44 ng/mL; P = .03).
2 context sentences(design, population, supporting numbers)
Summary · context
Four women had no increase in BMD and a blunted, delayed increase in serum P1NP.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.InterventionTeriparatide was administered at 20 μg daily for 18 to 24 months.
In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).
Report a problemFND-2354366016
17HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyOther
Among teriparatide-treated premenopausal women, BMD nonresponders had higher baseline serum IGF-1 than responders.
In plain wordsAmong women receiving teriparatide, those without bone density improvement had higher IGF-1 before treatment than responders.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseBaseline IGF-1 and BMD nonresponse
Study
n = 21
Comparator
BMD responders
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Measurements
Baseline serum IGF-1
208 ng/mL
BMD nonresponders
Baseline serum IGF-1 SD
54 ng/mL
BMD nonresponders SD
Baseline serum IGF-1
157 ng/mL
BMD responders
Baseline serum IGF-1 SD
44 ng/mL
BMD responders SD
Source sentences
Summary
Nonresponders had markedly lower baseline bone formation rate (0.002 ± 0.001 vs 0.011 ± 0.006 mm²/mm/y; P < .001) and higher serum IGF-1 (208 ± 54 vs 157± 44 ng/mL; P = .03).
2 context sentences(design, population, supporting numbers)
Summary · context
Four women had no increase in BMD and a blunted, delayed increase in serum P1NP.
Summary · context
Participants were 21 premenopausal women with unexplained fragility fractures or low BMD.InterventionTeriparatide was administered at 20 μg daily for 18 to 24 months.
In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).
Report a problemFND-2354366017

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 2Results postedNCT01440803

Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women

Elizabeth Shanen = 412 Aug 2012 to 1 Feb 2019

Adult Idiopathic Generalized Osteoporosis

Trial page ClinicalTrials.govUpdated 11 Dec 2019

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

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