Effects of Combination Denosumab and High-Dose Teriparatide Administration on Bone Microarchitecture and Estimated Strength: The DATA-HD HR-pQCT Study.

Ramchand SK, David NL, Lee H, Bruce M, Bouxsein ML, Leder BZ, Tsai JN

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research19 Sept 2020Cited by 11 (Europe PMC)

PMID32790196DOI10.1002/jbmr.4161PepBankPUB-32790196

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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 study10

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

01HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, high-dose teriparatide with denosumab increased distal tibia total BMD more than standard-dose teriparatide with denosumab.
In plain wordsIn postmenopausal women, high-dose teriparatide with denosumab increased tibia bone density more than standard-dose teriparatide with denosumab.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseDistal tibia total BMD
Study
n = 69
Comparator
20 μg teriparatide with the same denosumab regimen
Outcome group
Bone and joint · Musculoskeletal
Studied dose
40 μg during months 0 to 9 · 9 monthsAs given in this study (human).
Measurements
total BMD increase
5.3%
high-dose group
total BMD increase
3.4%
standard-dose group
Source sentences
Summary
Over 15 months, increases in total BMD were higher in the HD-group than the SD-group at the distal tibia (5.3% versus 3.4%, p = 0.01) with a similar trend at the distal radius (2.6% versus 1.0%, p = 0.06).
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effects of these combinations on bone microarchitecture and estimated bone strength, we performed high-resolution peripheral quantitative computed tomography (HR-pQCT) at the distal radius and distal tibia in these women
Summary · context
The 69 women who completed at least one study visit after baseline are included in this analysis.
Report a problemFND-3279019601
02HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, distal radius BMD gains showed a nonsignificant trend favoring high-dose over standard-dose teriparatide with denosumab.
In plain wordsIn postmenopausal women, radius bone density gains did not differ significantly between high-dose and standard-dose teriparatide with denosumab.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeDistal radius total BMD
Study
n = 69
Comparator
20 μg teriparatide with the same denosumab regimen
Outcome group
Bone and joint · Musculoskeletal
Studied dose
40 μg during months 0 to 9 · 9 monthsAs given in this study (human).
Measurements
total BMD increase
2.6%
high-dose group
total BMD increase
1%
standard-dose group
Source sentences
Summary
Over 15 months, increases in total BMD were higher in the HD-group than the SD-group at the distal tibia (5.3% versus 3.4%, p = 0.01) with a similar trend at the distal radius (2.6% versus 1.0%, p = 0.06).
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effects of these combinations on bone microarchitecture and estimated bone strength, we performed high-resolution peripheral quantitative computed tomography (HR-pQCT) at the distal radius and distal tibia in these women
Summary · context
The 69 women who completed at least one study visit after baseline are included in this analysis.
Report a problemFND-3279019602
03HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, tibial cortical tissue mineral density gains were similar between high-dose and standard-dose teriparatide with denosumab.
In plain wordsIn postmenopausal women, tibial cortical mineral density gains were similar between high-dose and standard-dose teriparatide with denosumab.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeTibial cortical tissue mineral density between doses
Study
n = 69
Comparator
20 μg teriparatide with the same denosumab regimen
Outcome group
Bone and joint · Musculoskeletal
Studied dose
40 μg during months 0 to 9 · 9 monthsAs given in this study (human).
Measurements
tissue mineral density increase
1.3%
high-dose group tibial cortical
tissue mineral density increase
1.5%
standard-dose group tibial cortical
Source sentences
Summary
Tibial cortical tissue mineral density increased similarly in both treatment groups (1.3% [p < 0.0001 versus baseline] and 1.5% [p < 0.0001 versus baseline] in the HD-group and SD-group, respectively; p = 0.75 for overall group difference).
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effects of these combinations on bone microarchitecture and estimated bone strength, we performed high-resolution peripheral quantitative computed tomography (HR-pQCT) at the distal radius and distal tibia in these women
Summary · context
The 69 women who completed at least one study visit after baseline are included in this analysis.
Report a problemFND-3279019607
04HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, tibial trabecular microarchitecture gains were numerically greater but nonsignificant with high-dose versus standard-dose teriparatide with denosumab.
In plain wordsIn postmenopausal women, tibial trabecular gains did not differ significantly between high-dose and standard-dose teriparatide with denosumab.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeDistal tibia trabecular microarchitecture
Study
n = 69
Comparator
20 μg teriparatide with the same denosumab regimen
Outcome group
Bone and joint · Musculoskeletal
Studied dose
40 μg during months 0 to 9 · 9 monthsAs given in this study (human).
Source sentences
Summary
Improvements in trabecular microarchitecture at the distal tibia and estimated strength by micro-finite element analysis at both sites were numerically greater in the HD-group compared with SD-group but not significantly so.
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effects of these combinations on bone microarchitecture and estimated bone strength, we performed high-resolution peripheral quantitative computed tomography (HR-pQCT) at the distal radius and distal tibia in these women
Summary · context
The 69 women who completed at least one study visit after baseline are included in this analysis.
Report a problemFND-3279019608
05HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, tibial estimated strength gains were numerically greater but nonsignificant with high-dose versus standard-dose teriparatide with denosumab.
In plain wordsIn postmenopausal women, estimated tibial strength gains did not differ significantly between high-dose and standard-dose teriparatide with denosumab.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeDistal tibia estimated strength
Study
n = 69
Comparator
20 μg teriparatide with the same denosumab regimen
Outcome group
Bone and joint · Musculoskeletal
Studied dose
40 μg during months 0 to 9 · 9 monthsAs given in this study (human).
Source sentences
Summary
Improvements in trabecular microarchitecture at the distal tibia and estimated strength by micro-finite element analysis at both sites were numerically greater in the HD-group compared with SD-group but not significantly so.
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effects of these combinations on bone microarchitecture and estimated bone strength, we performed high-resolution peripheral quantitative computed tomography (HR-pQCT) at the distal radius and distal tibia in these women
Summary · context
The 69 women who completed at least one study visit after baseline are included in this analysis.
Report a problemFND-3279019609
06HumanRandomized controlled trialEfficacy outcome
In postmenopausal women, radial estimated strength gains were numerically greater but nonsignificant with high-dose versus standard-dose teriparatide with denosumab.
In plain wordsIn postmenopausal women, estimated radial strength gains did not differ significantly between high-dose and standard-dose teriparatide with denosumab.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeDistal radius estimated strength
Study
n = 69
Comparator
20 μg teriparatide with the same denosumab regimen
Outcome group
Bone and joint · Musculoskeletal
Studied dose
40 μg during months 0 to 9 · 9 monthsAs given in this study (human).
Source sentences
Summary
Improvements in trabecular microarchitecture at the distal tibia and estimated strength by micro-finite element analysis at both sites were numerically greater in the HD-group compared with SD-group but not significantly so.
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effects of these combinations on bone microarchitecture and estimated bone strength, we performed high-resolution peripheral quantitative computed tomography (HR-pQCT) at the distal radius and distal tibia in these women
Summary · context
The 69 women who completed at least one study visit after baseline are included in this analysis.
Report a problemFND-3279019610

Studies that did not test the peptide alone4

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).

07HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome
In postmenopausal women, tibial cortical porosity remained similar to baseline with both teriparatide-denosumab regimens.
In plain wordsIn postmenopausal women, tibial bone porosity remained similar to baseline with both teriparatide-denosumab regimens.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeTibial cortical porosity
Study
n = 69
Comparator
baseline
Outcome group
Bone and joint · Musculoskeletal
Measurements
absolute porosity difference
−0.1%
high-dose group distal tibia
absolute porosity difference
−0.7%
standard-dose group distal tibia
Source sentences
Summary
At 15 months, cortical porosity remained similar to baseline, with absolute differences of -0.1% and -0.7% at the distal tibia and -0.4% and -0.1% at the distal radius in the HD-group and SD-group, respectively; p = NS for all comparisons.
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effects of these combinations on bone microarchitecture and estimated bone strength, we performed high-resolution peripheral quantitative computed tomography (HR-pQCT) at the distal radius and distal tibia in these women
Summary · context
The 69 women who completed at least one study visit after baseline are included in this analysis.
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-3279019603
08HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome
In postmenopausal women, radial cortical porosity remained similar to baseline with both teriparatide-denosumab regimens.
In plain wordsIn postmenopausal women, radial bone porosity remained similar to baseline with both teriparatide-denosumab regimens.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeRadial cortical porosity
Study
n = 69
Comparator
baseline
Outcome group
Bone and joint · Musculoskeletal
Measurements
absolute porosity difference
−0.4%
high-dose group distal radius
absolute porosity difference
−0.1%
standard-dose group distal radius
Source sentences
Summary
At 15 months, cortical porosity remained similar to baseline, with absolute differences of -0.1% and -0.7% at the distal tibia and -0.4% and -0.1% at the distal radius in the HD-group and SD-group, respectively; p = NS for all comparisons.
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effects of these combinations on bone microarchitecture and estimated bone strength, we performed high-resolution peripheral quantitative computed tomography (HR-pQCT) at the distal radius and distal tibia in these women
Summary · context
The 69 women who completed at least one study visit after baseline are included in this analysis.
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-3279019604
09HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome
In postmenopausal women, tibial cortical tissue mineral density increased with high-dose teriparatide plus denosumab compared with baseline.
In plain wordsIn postmenopausal women, tibial cortical tissue mineral density increased from baseline with high-dose teriparatide plus denosumab.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseTibial cortical tissue mineral density, high-dose combination
Study
n: not reported in source
Comparator
baseline
Outcome group
Bone and joint · Musculoskeletal
Measurements
tissue mineral density increase
1.3%
high-dose group
Source sentences
Summary
Tibial cortical tissue mineral density increased similarly in both treatment groups (1.3% [p < 0.0001 versus baseline] and 1.5% [p < 0.0001 versus baseline] in the HD-group and SD-group, respectively; p = 0.75 for overall group difference).
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effects of these combinations on bone microarchitecture and estimated bone strength, we performed high-resolution peripheral quantitative computed tomography (HR-pQCT) at the distal radius and distal tibia in these women
Summary · context
The 69 women who completed at least one study visit after baseline are included in this analysis.
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-3279019605
10HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome
In postmenopausal women, tibial cortical tissue mineral density increased with standard-dose teriparatide plus denosumab compared with baseline.
In plain wordsIn postmenopausal women, tibial cortical tissue mineral density increased from baseline with standard-dose teriparatide plus denosumab.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseTibial cortical tissue mineral density, standard-dose combination
Study
n: not reported in source
Comparator
baseline
Outcome group
Bone and joint · Musculoskeletal
Measurements
tissue mineral density increase
1.5%
standard-dose group
Source sentences
Summary
Tibial cortical tissue mineral density increased similarly in both treatment groups (1.3% [p < 0.0001 versus baseline] and 1.5% [p < 0.0001 versus baseline] in the HD-group and SD-group, respectively; p = 0.75 for overall group difference).
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effects of these combinations on bone microarchitecture and estimated bone strength, we performed high-resolution peripheral quantitative computed tomography (HR-pQCT) at the distal radius and distal tibia in these women
Summary · context
The 69 women who completed at least one study visit after baseline are included in this analysis.
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-3279019606

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 postedNCT02176382

Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

Massachusetts General Hospitaln = 76Aug 2014 to Feb 2020

Postmenopausal Osteoporosis

Trial page ClinicalTrials.govUpdated 9 Feb 2021

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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