Study · Non-randomized trial · n = 10 · 2016

10 results

A Longitudinal Study of Skeletal Histomorphometry at 6 and 24 Months Across Four Bone Envelopes in Postmenopausal Women With Osteoporosis Receiving Teriparatide or Zoledronic Acid in the SHOTZ Trial.

Dempster DW, Zhou H, Recker RR, Brown JP, Bolognese MA, Recknor CP, Kendler DL, Lewiecki EM, Hanley DA, Rao SD, Miller PD, Woodson GC 3rd and 6 more

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Lindsay R, Binkley N, Alam J, Ruff VA, Gallagher ER, Taylor KA

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research8 Mar 2016Cited by 33 (Europe PMC)

PMID26841258DOI10.1002/jbmr.2804PepBankPUB-26841258

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Summary

Previously, we reported the effects of teriparatide (TPTD) and zoledronic acid (ZOL) on bone formation based on biochemical markers and bone histomorphometry of the cancellous envelope at month 6 in postmenopausal women with osteoporosis who participated in the 12-month primary Skeletal Histomorphometry in Subjects on Teriparatide or Zoledronic Acid Therapy (SHOTZ) study. Patients were eligible to enter a 12-month extension on their original treatment regimen: TPTD 20 μg/day (s.c. injection) or ZOL 5 mg/year (i.v. infusion). A second biopsy was performed at month 24. Here we report longitudinal changes between and within each treatment group in the cancellous, endocortical, intracortical, and periosteal bone envelopes in patients with evaluable biopsies at months 6 and 24 (paired data set: TPTD, n = 10; ZOL, n = 9). Between-group differences are also reported in the larger set of patients with evaluable biopsies at month 6 (TPTD, n = 28; ZOL, n = 30). Data from the cancellous envelope at month 6 or month 24 provided a reference to compare differences across envelopes within each treatment group. The 24-month results extend our earlier report that TPTD and ZOL possess different tissue-level mechanisms of action. Moreover, these differences persisted for at least 2 years in all four bone envelopes. Few longitudinal differences were observed within or across bone envelopes in ZOL-treated patients, suggesting that the low bone formation indices at month 6 persisted to month 24. Conversely, the magnitude of the effect of TPTD on bone formation varied across individual envelopes: median values for mineralizing surface (MS/BS) and bone formation rate (BFR/BS) at month 6 were approximately 3-fold to 5-fold higher in the endocortical and intracortical envelopes compared to the cancellous envelope. Although MS/BS and BFR/BS declined in these envelopes at month 24, median values continued to exceed, or were not significantly different from, those in the cancellous envelope. This study demonstrates for the first time that bone formation indices are higher with TPTD treatment than with ZOL in all four bone envelopes and the difference persists for at least 2 years. Moreover, the magnitude of the effect of TPTD in cortical bone remains robust at 24 months. © 2016 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research (ASBMR).

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study10

4 results from studies that gave the peptide. 4 results from people.

01HumanNon-randomized trialEfficacy outcome
In women receiving teriparatide, endocortical mineralizing surface declined from month 6 to month 24.
In plain wordsIn women receiving teriparatide, endocortical mineralizing surface declined from month 6 to month 24.
Peptide
Teriparatide (PTH 1-34)
Outcome
DecreaseEndocortical mineralizing surface over time
Study
n = 10
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg/day · subcutaneous injection · 24 monthsAs given in this study (human).
Source sentences
Summary
Although MS/BS and BFR/BS declined in these envelopes at month 24, median values continued to exceed, or were not significantly different from, those in the cancellous envelope.
3 context sentences(design, population, supporting numbers)
Summary · context
Conversely, the magnitude of the effect of TPTD on bone formation varied across individual envelopes: median values for mineralizing surface (MS/BS) and bone formation rate (BFR/BS) at month 6 were approximately 3-fold to 5-fold higher in the endocortical and intracortical envelopes compared to the cancellous envelope.
Summary · context
Patients were eligible to enter a 12-month extension on their original treatment regimen: TPTD 20 μg/day (s.c. injection) or ZOL 5 mg/year (i.v. infusion).
Summary · context
Here we report longitudinal changes between and within each treatment group in the cancellous, endocortical, intracortical, and periosteal bone envelopes in patients with evaluable biopsies at months 6 and 24 (paired data set: TPTD, n = 10; ZOL, n = 9).
Show in the study text Report a problemFND-2684125805
02HumanNon-randomized trialEfficacy outcome
In women receiving teriparatide, intracortical mineralizing surface declined from month 6 to month 24.
In plain wordsIn women receiving teriparatide, intracortical mineralizing surface declined from month 6 to month 24.
Peptide
Teriparatide (PTH 1-34)
Outcome
DecreaseIntracortical mineralizing surface over time
Study
n = 10
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg/day · subcutaneous injection · 24 monthsAs given in this study (human).
Source sentences
Summary
Although MS/BS and BFR/BS declined in these envelopes at month 24, median values continued to exceed, or were not significantly different from, those in the cancellous envelope.
3 context sentences(design, population, supporting numbers)
Summary · context
Conversely, the magnitude of the effect of TPTD on bone formation varied across individual envelopes: median values for mineralizing surface (MS/BS) and bone formation rate (BFR/BS) at month 6 were approximately 3-fold to 5-fold higher in the endocortical and intracortical envelopes compared to the cancellous envelope.
Summary · context
Patients were eligible to enter a 12-month extension on their original treatment regimen: TPTD 20 μg/day (s.c. injection) or ZOL 5 mg/year (i.v. infusion).
Summary · context
Here we report longitudinal changes between and within each treatment group in the cancellous, endocortical, intracortical, and periosteal bone envelopes in patients with evaluable biopsies at months 6 and 24 (paired data set: TPTD, n = 10; ZOL, n = 9).
Show in the study text Report a problemFND-2684125806
03HumanNon-randomized trialEfficacy outcome
In women receiving teriparatide, endocortical bone formation rate declined from month 6 to month 24.
In plain wordsIn women receiving teriparatide, endocortical bone formation declined from month 6 to month 24.
Peptide
Teriparatide (PTH 1-34)
Outcome
DecreaseEndocortical bone formation rate over time
Study
n = 10
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg/day · subcutaneous injection · 24 monthsAs given in this study (human).
Source sentences
Summary
Although MS/BS and BFR/BS declined in these envelopes at month 24, median values continued to exceed, or were not significantly different from, those in the cancellous envelope.
3 context sentences(design, population, supporting numbers)
Summary · context
Conversely, the magnitude of the effect of TPTD on bone formation varied across individual envelopes: median values for mineralizing surface (MS/BS) and bone formation rate (BFR/BS) at month 6 were approximately 3-fold to 5-fold higher in the endocortical and intracortical envelopes compared to the cancellous envelope.
Summary · context
Patients were eligible to enter a 12-month extension on their original treatment regimen: TPTD 20 μg/day (s.c. injection) or ZOL 5 mg/year (i.v. infusion).
Summary · context
Here we report longitudinal changes between and within each treatment group in the cancellous, endocortical, intracortical, and periosteal bone envelopes in patients with evaluable biopsies at months 6 and 24 (paired data set: TPTD, n = 10; ZOL, n = 9).
Show in the study text Report a problemFND-2684125807
04HumanNon-randomized trialEfficacy outcome
In women receiving teriparatide, intracortical bone formation rate declined from month 6 to month 24.
In plain wordsIn women receiving teriparatide, intracortical bone formation declined from month 6 to month 24.
Peptide
Teriparatide (PTH 1-34)
Outcome
DecreaseIntracortical bone formation rate over time
Study
n = 10
Outcome group
Bone and joint · Musculoskeletal
Studied dose
20 μg/day · subcutaneous injection · 24 monthsAs given in this study (human).
Source sentences
Summary
Although MS/BS and BFR/BS declined in these envelopes at month 24, median values continued to exceed, or were not significantly different from, those in the cancellous envelope.
3 context sentences(design, population, supporting numbers)
Summary · context
Conversely, the magnitude of the effect of TPTD on bone formation varied across individual envelopes: median values for mineralizing surface (MS/BS) and bone formation rate (BFR/BS) at month 6 were approximately 3-fold to 5-fold higher in the endocortical and intracortical envelopes compared to the cancellous envelope.
Summary · context
Patients were eligible to enter a 12-month extension on their original treatment regimen: TPTD 20 μg/day (s.c. injection) or ZOL 5 mg/year (i.v. infusion).
Summary · context
Here we report longitudinal changes between and within each treatment group in the cancellous, endocortical, intracortical, and periosteal bone envelopes in patients with evaluable biopsies at months 6 and 24 (paired data set: TPTD, n = 10; ZOL, n = 9).
Show in the study text Report a problemFND-2684125808

Studies that did not test the peptide alone6

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).

05HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyEfficacy outcome
In women receiving teriparatide, cortical mineralizing surface remained above or not significantly different from cancellous values at month 24.
In plain wordsIn women receiving teriparatide, cortical mineralizing surface remained above or similar to cancellous values at month 24.
Peptide
Teriparatide (PTH 1-34)
Outcome
MixedCortical mineralizing surface relative to cancellous bone at month 24
Study
n = 10
Comparator
cancellous envelope
Outcome group
Bone and joint · Musculoskeletal
Source sentences
Summary
Although MS/BS and BFR/BS declined in these envelopes at month 24, median values continued to exceed, or were not significantly different from, those in the cancellous envelope.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were eligible to enter a 12-month extension on their original treatment regimen: TPTD 20 μg/day (s.c. injection) or ZOL 5 mg/year (i.v. infusion).
Summary · context
Here we report longitudinal changes between and within each treatment group in the cancellous, endocortical, intracortical, and periosteal bone envelopes in patients with evaluable biopsies at months 6 and 24 (paired data set: TPTD, n = 10; ZOL, n = 9).
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).
Show in the study text Report a problemFND-2684125809
06HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyEfficacy outcome
In women receiving teriparatide, cortical bone formation rate remained above or not significantly different from cancellous values at month 24.
In plain wordsIn women receiving teriparatide, cortical bone formation rate remained above or similar to cancellous values at month 24.
Peptide
Teriparatide (PTH 1-34)
Outcome
MixedCortical bone formation rate relative to cancellous bone at month 24
Study
n = 10
Comparator
cancellous envelope
Outcome group
Bone and joint · Musculoskeletal
Source sentences
Summary
Although MS/BS and BFR/BS declined in these envelopes at month 24, median values continued to exceed, or were not significantly different from, those in the cancellous envelope.
3 context sentences(design, population, supporting numbers)
Summary · context
Conversely, the magnitude of the effect of TPTD on bone formation varied across individual envelopes: median values for mineralizing surface (MS/BS) and bone formation rate (BFR/BS) at month 6 were approximately 3-fold to 5-fold higher in the endocortical and intracortical envelopes compared to the cancellous envelope.
Summary · context
Patients were eligible to enter a 12-month extension on their original treatment regimen: TPTD 20 μg/day (s.c. injection) or ZOL 5 mg/year (i.v. infusion).
Summary · context
Here we report longitudinal changes between and within each treatment group in the cancellous, endocortical, intracortical, and periosteal bone envelopes in patients with evaluable biopsies at months 6 and 24 (paired data set: TPTD, n = 10; ZOL, n = 9).
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).
Show in the study text Report a problemFND-2684125810
07HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyEfficacy outcome
In women with osteoporosis receiving teriparatide, endocortical mineralizing surface was approximately 3-fold to 5-fold higher than cancellous values at month 6.
In plain wordsIn women receiving teriparatide, mineralizing surface was higher in endocortical than cancellous bone at month 6.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseEndocortical mineralizing surface at month 6
Study
n: not reported in source
Comparator
cancellous envelope
Outcome group
Bone and joint · Musculoskeletal
Measurements
Fold difference versus cancellous envelope
3 to 5 fold
endocortical mineralizing surface (MS/BS) versus cancellous at month 6; approximately 3-fold to 5-fold range stated for both indices in both envelopes
Source sentences
Summary
Conversely, the magnitude of the effect of TPTD on bone formation varied across individual envelopes: median values for mineralizing surface (MS/BS) and bone formation rate (BFR/BS) at month 6 were approximately 3-fold to 5-fold higher in the endocortical and intracortical envelopes compared to the cancellous envelope.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were eligible to enter a 12-month extension on their original treatment regimen: TPTD 20 μg/day (s.c. injection) or ZOL 5 mg/year (i.v. infusion).
Summary · context
Here we report longitudinal changes between and within each treatment group in the cancellous, endocortical, intracortical, and periosteal bone envelopes in patients with evaluable biopsies at months 6 and 24 (paired data set: TPTD, n = 10; ZOL, n = 9).
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).
Show in the study text Report a problemFND-2684125801
08HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyEfficacy outcome
In women with osteoporosis receiving teriparatide, intracortical mineralizing surface was approximately 3-fold to 5-fold higher than cancellous values at month 6.
In plain wordsIn women receiving teriparatide, mineralizing surface was higher in intracortical than cancellous bone at month 6.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseIntracortical mineralizing surface at month 6
Study
n: not reported in source
Comparator
cancellous envelope
Outcome group
Bone and joint · Musculoskeletal
Measurements
Fold difference versus cancellous envelope
3 to 5 fold
intracortical mineralizing surface (MS/BS) versus cancellous at month 6; approximately 3-fold to 5-fold range stated for both indices in both envelopes
Source sentences
Summary
Conversely, the magnitude of the effect of TPTD on bone formation varied across individual envelopes: median values for mineralizing surface (MS/BS) and bone formation rate (BFR/BS) at month 6 were approximately 3-fold to 5-fold higher in the endocortical and intracortical envelopes compared to the cancellous envelope.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were eligible to enter a 12-month extension on their original treatment regimen: TPTD 20 μg/day (s.c. injection) or ZOL 5 mg/year (i.v. infusion).
Summary · context
Here we report longitudinal changes between and within each treatment group in the cancellous, endocortical, intracortical, and periosteal bone envelopes in patients with evaluable biopsies at months 6 and 24 (paired data set: TPTD, n = 10; ZOL, n = 9).
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).
Show in the study text Report a problemFND-2684125802
09HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyEfficacy outcome
In women with osteoporosis receiving teriparatide, endocortical bone formation rate was approximately 3-fold to 5-fold higher than cancellous values at month 6.
In plain wordsIn women receiving teriparatide, bone formation was higher in endocortical than cancellous bone at month 6.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseEndocortical bone formation rate at month 6
Study
n: not reported in source
Comparator
cancellous envelope
Outcome group
Bone and joint · Musculoskeletal
Measurements
Fold difference versus cancellous envelope
3 to 5 fold
endocortical bone formation rate (BFR/BS) versus cancellous at month 6; approximately 3-fold to 5-fold range stated for both indices in both envelopes
Source sentences
Summary
Conversely, the magnitude of the effect of TPTD on bone formation varied across individual envelopes: median values for mineralizing surface (MS/BS) and bone formation rate (BFR/BS) at month 6 were approximately 3-fold to 5-fold higher in the endocortical and intracortical envelopes compared to the cancellous envelope.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were eligible to enter a 12-month extension on their original treatment regimen: TPTD 20 μg/day (s.c. injection) or ZOL 5 mg/year (i.v. infusion).
Summary · context
Here we report longitudinal changes between and within each treatment group in the cancellous, endocortical, intracortical, and periosteal bone envelopes in patients with evaluable biopsies at months 6 and 24 (paired data set: TPTD, n = 10; ZOL, n = 9).
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).
Show in the study text Report a problemFND-2684125803
10HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyEfficacy outcome
In women with osteoporosis receiving teriparatide, intracortical bone formation rate was approximately 3-fold to 5-fold higher than cancellous values at month 6.
In plain wordsIn women receiving teriparatide, bone formation was higher in intracortical than cancellous bone at month 6.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseIntracortical bone formation rate at month 6
Study
n: not reported in source
Comparator
cancellous envelope
Outcome group
Bone and joint · Musculoskeletal
Measurements
Fold difference versus cancellous envelope
3 to 5 fold
intracortical bone formation rate (BFR/BS) versus cancellous at month 6; approximately 3-fold to 5-fold range stated for both indices in both envelopes
Source sentences
Summary
Conversely, the magnitude of the effect of TPTD on bone formation varied across individual envelopes: median values for mineralizing surface (MS/BS) and bone formation rate (BFR/BS) at month 6 were approximately 3-fold to 5-fold higher in the endocortical and intracortical envelopes compared to the cancellous envelope.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were eligible to enter a 12-month extension on their original treatment regimen: TPTD 20 μg/day (s.c. injection) or ZOL 5 mg/year (i.v. infusion).
Summary · context
Here we report longitudinal changes between and within each treatment group in the cancellous, endocortical, intracortical, and periosteal bone envelopes in patients with evaluable biopsies at months 6 and 24 (paired data set: TPTD, n = 10; ZOL, n = 9).
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).
Show in the study text Report a problemFND-2684125804

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 4Results postedNCT00927186

Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women

Eli Lilly and Companyn = 69Jul 2009 to Apr 2012

Osteoporosis, Post-menopausal

Trial page ClinicalTrials.govUpdated 4 Apr 2013

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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