Combination denosumab and high dose teriparatide for postmenopausal osteoporosis (DATA-HD): a randomised, controlled phase 4 trial.

Tsai JN, Lee H, David NL, Eastell R, Leder BZ

The lancet. Diabetes & endocrinology22 Aug 2019Cited by 56 (Europe PMC)

PMID31447409PMCIDPMC6980341DOI10.1016/s2213-8587(19)30255-4PepBankPUB-31447409

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 study14

3 results from studies that gave the peptide. 3 results from people.

01HumanRandomized controlled trialEfficacy outcome
In postmenopausal women with osteoporosis receiving denosumab, high-dose teriparatide increased spine aBMD more than standard-dose teriparatide.
In plain wordsIn women with osteoporosis receiving denosumab, high-dose teriparatide increased spine bone density more than standard-dose teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseSpine aBMD at 15 months
Study
n = 69
Comparator
Teriparatide 20 μg plus denosumab
Analysis
Primary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
40 μg daily · subcutaneous injection · 9 monthsAs given in this study (human).
Measurements
Spine aBMD increase
17.5%
high dose
Spine aBMD increase
9.5%
standard dose
Between-group difference in spine aBMD
8.1%
high dose minus standard dose
Source sentences
Summary
At 15 months, mean spine aBMD had increased to a significantly greater extent in the 40 μg group (17·5% [SD 6·0] increase) than the 20 μg group (9·5% [3·2]; difference 8·1%, 95% CI 5·5 to 10·6, p<0·0001).
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis.
Summary · context
Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months.
Summary · context
At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 months.
Report a problemFND-3144740901
02HumanRandomized controlled trialEfficacy outcome
In postmenopausal women with osteoporosis receiving denosumab, high-dose teriparatide increased femoral neck aBMD more than standard-dose teriparatide.
In plain wordsIn women receiving denosumab, high-dose teriparatide increased femoral neck bone density more than standard-dose teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseFemoral neck aBMD
Study
n = 69
Comparator
Teriparatide 20 μg plus denosumab
Outcome group
Bone and joint · Musculoskeletal
Studied dose
40 μg daily · subcutaneous injection · 9 monthsAs given in this study (human).
Measurements
Femoral neck aBMD increase
6.8%
high dose
Femoral neck aBMD increase
4.3%
standard dose
Between-group difference in femoral neck aBMD
2.5%
high dose minus standard dose
Source sentences
Summary
Mean femoral neck aBMD had also increased to a greater extent in the 40 μg group (6·8% [SD 4·1] increase) than the 20 μg group (4·3% [3·7]; difference 2·5%, 0·5 to 4·5, p=0·04), as did mean total hip aBMD (40 μg group, 6·1% [3·4] increase; 20 μg group, 3·9% [2·9] increase; difference 2·2%, 0·6 to 3·8, p<0·0001).
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis.
Summary · context
Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months.
Summary · context
At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 months.
Report a problemFND-3144740902
03HumanRandomized controlled trialEfficacy outcome
In postmenopausal women with osteoporosis receiving denosumab, high-dose teriparatide increased total hip aBMD more than standard-dose teriparatide.
In plain wordsIn women receiving denosumab, high-dose teriparatide increased total hip bone density more than standard-dose teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseTotal hip aBMD
Study
n = 69
Comparator
Teriparatide 20 μg plus denosumab
Outcome group
Bone and joint · Musculoskeletal
Studied dose
40 μg daily · subcutaneous injection · 9 monthsAs given in this study (human).
Measurements
Total hip aBMD increase
6.1%
high dose
Total hip aBMD increase
3.9%
standard dose
Between-group difference in total hip aBMD
2.2%
high dose minus standard dose
Source sentences
Summary
Mean femoral neck aBMD had also increased to a greater extent in the 40 μg group (6·8% [SD 4·1] increase) than the 20 μg group (4·3% [3·7]; difference 2·5%, 0·5 to 4·5, p=0·04), as did mean total hip aBMD (40 μg group, 6·1% [3·4] increase; 20 μg group, 3·9% [2·9] increase; difference 2·2%, 0·6 to 3·8, p<0·0001).
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis.
Summary · context
Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months.
Summary · context
At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 months.
Report a problemFND-3144740903

Studies that did not test the peptide alone11

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).

04HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialSafety outcome
In women with osteoporosis receiving teriparatide plus denosumab, no deaths were reported.
In plain wordsIn women with osteoporosis receiving teriparatide with denosumab, no deaths were reported.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedDeaths
Study
n = 76
Outcome group
Mortality · Whole body
Source sentences
Summary
No deaths were reported.
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis.
Summary · context
Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months.
Summary · context
At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 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-3144740914
05HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialSafety outcome
In women with osteoporosis, adverse events occurred with standard-dose teriparatide plus denosumab.
In plain wordsIn women with osteoporosis, standard-dose teriparatide with denosumab had adverse events.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedAdverse events with standard dose
Study
n = 39
Outcome group
Adverse events · Whole body
Measurements
Adverse events
77%
standard dose plus denosumab
Source sentences
Summary
30 (77%) of 39 participants in the 20 μg group and 29 (78%) of 37 participants in the 40 μg group had an adverse event, and seven (18%) and two (5%) patients had serious adverse events.
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis.
Summary · context
Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months.
Summary · context
At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 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-3144740904
06HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialSafety outcome
In women with osteoporosis, serious adverse events occurred with standard-dose teriparatide plus denosumab.
In plain wordsIn women with osteoporosis, standard-dose teriparatide with denosumab had serious adverse events.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedSerious adverse events with standard dose
Study
n = 39
Outcome group
Adverse events · Whole body
Measurements
Serious adverse events
18%
standard dose plus denosumab
Source sentences
Summary
30 (77%) of 39 participants in the 20 μg group and 29 (78%) of 37 participants in the 40 μg group had an adverse event, and seven (18%) and two (5%) patients had serious adverse events.
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis.
Summary · context
Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months.
Summary · context
At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 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-3144740906
07HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialSafety outcome
In women with osteoporosis, joint pain occurred with standard-dose teriparatide plus denosumab.
In plain wordsIn women with osteoporosis, standard-dose teriparatide with denosumab had joint pain.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedJoint pain with standard dose
Study
n = 39
Outcome group
Adverse events · Musculoskeletal
Measurements
Joint pain
38%
standard dose
Source sentences
Summary
The most frequent adverse events were joint pain (15 [38%]), muscle cramp (15 [38%]), and fatigue (12 [31%]) in the 20 μg group group and fatigue (14 [38%]), nausea (16 [43%]), and joint pain (17 [46%]) in the 40 μg group.
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis.
Summary · context
Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months.
Summary · context
At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 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-3144740908
08HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialSafety outcome
In women with osteoporosis, muscle cramp occurred with standard-dose teriparatide plus denosumab.
In plain wordsIn women with osteoporosis, standard-dose teriparatide with denosumab had muscle cramps.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedMuscle cramp
Study
n = 39
Outcome group
Adverse events · Musculoskeletal
Measurements
Muscle cramp
38%
standard dose
Source sentences
Summary
The most frequent adverse events were joint pain (15 [38%]), muscle cramp (15 [38%]), and fatigue (12 [31%]) in the 20 μg group group and fatigue (14 [38%]), nausea (16 [43%]), and joint pain (17 [46%]) in the 40 μg group.
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis.
Summary · context
Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months.
Summary · context
At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 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-3144740910
09HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialSafety outcome
In women with osteoporosis, fatigue occurred with standard-dose teriparatide plus denosumab.
In plain wordsIn women with osteoporosis, standard-dose teriparatide with denosumab had fatigue.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedFatigue with standard dose
Study
n = 39
Outcome group
Adverse events · Whole body
Measurements
Fatigue
31%
standard dose
Source sentences
Summary
The most frequent adverse events were joint pain (15 [38%]), muscle cramp (15 [38%]), and fatigue (12 [31%]) in the 20 μg group group and fatigue (14 [38%]), nausea (16 [43%]), and joint pain (17 [46%]) in the 40 μg group.
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis.
Summary · context
Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months.
Summary · context
At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 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-3144740911
10HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialSafety outcome
In women with osteoporosis, adverse events occurred with high-dose teriparatide plus denosumab.
In plain wordsIn women with osteoporosis, high-dose teriparatide with denosumab had adverse events.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedAdverse events with high dose
Study
n = 37
Outcome group
Adverse events · Whole body
Measurements
Adverse events
78%
high dose plus denosumab
Source sentences
Summary
30 (77%) of 39 participants in the 20 μg group and 29 (78%) of 37 participants in the 40 μg group had an adverse event, and seven (18%) and two (5%) patients had serious adverse events.
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis.
Summary · context
Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months.
Summary · context
At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 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-3144740905
11HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialSafety outcome
In women with osteoporosis, serious adverse events occurred with high-dose teriparatide plus denosumab.
In plain wordsIn women with osteoporosis, high-dose teriparatide with denosumab had serious adverse events.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedSerious adverse events with high dose
Study
n = 37
Outcome group
Adverse events · Whole body
Measurements
Serious adverse events
5%
high dose plus denosumab
Source sentences
Summary
30 (77%) of 39 participants in the 20 μg group and 29 (78%) of 37 participants in the 40 μg group had an adverse event, and seven (18%) and two (5%) patients had serious adverse events.
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis.
Summary · context
Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months.
Summary · context
At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 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-3144740907
12HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialSafety outcome
In women with osteoporosis, joint pain occurred with high-dose teriparatide plus denosumab.
In plain wordsIn women with osteoporosis, high-dose teriparatide with denosumab had joint pain.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedJoint pain with high dose
Study
n = 37
Outcome group
Adverse events · Musculoskeletal
Measurements
Joint pain
46%
high dose
Source sentences
Summary
The most frequent adverse events were joint pain (15 [38%]), muscle cramp (15 [38%]), and fatigue (12 [31%]) in the 20 μg group group and fatigue (14 [38%]), nausea (16 [43%]), and joint pain (17 [46%]) in the 40 μg group.
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis.
Summary · context
Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months.
Summary · context
At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 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-3144740909
13HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialSafety outcome
In women with osteoporosis, fatigue occurred with high-dose teriparatide plus denosumab.
In plain wordsIn women with osteoporosis, high-dose teriparatide with denosumab had fatigue.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedFatigue with high dose
Study
n = 37
Outcome group
Adverse events · Whole body
Measurements
Fatigue
38%
high dose
Source sentences
Summary
The most frequent adverse events were joint pain (15 [38%]), muscle cramp (15 [38%]), and fatigue (12 [31%]) in the 20 μg group group and fatigue (14 [38%]), nausea (16 [43%]), and joint pain (17 [46%]) in the 40 μg group.
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis.
Summary · context
Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months.
Summary · context
At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 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-3144740912
14HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialSafety outcome
In women with osteoporosis, nausea occurred with high-dose teriparatide plus denosumab.
In plain wordsIn women with osteoporosis, high-dose teriparatide with denosumab had nausea.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedNausea
Study
n = 37
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Measurements
Nausea
43%
high dose
Source sentences
Summary
The most frequent adverse events were joint pain (15 [38%]), muscle cramp (15 [38%]), and fatigue (12 [31%]) in the 20 μg group group and fatigue (14 [38%]), nausea (16 [43%]), and joint pain (17 [46%]) in the 40 μg group.
3 context sentences(design, population, supporting numbers)
Summary · context
Eligible women were postmenopausal women (at least 36 months since last menses or since hysterectomy with a follicle-stimulating hormone concentration of ≥40 U/L) with osteoporosis.
Summary · context
Participants were randomly assigned (1:1) to receive teriparatide 20 μg (standard dose) or 40 μg (high dose) daily via subcutaneous injection for 9 months.
Summary · context
At 3 months, both groups were started on denosumab 60 mg every 6 months via subcutaneous injection for 12 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-3144740913

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.

Publication types

MeSH terms

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