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Study · Randomized controlled trial · 2013

9 results

Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial.

Tsai JN, Uihlein AV, Lee H, Kumbhani R, Siwila-Sackman E, McKay EA, Burnett-Bowie SA, Neer RM, Leder BZ

Lancet (London, England)15 May 2013Cited by 335 (Europe PMC)

PMID23683600 (opens in a new tab)PMCIDPMC4083737 (opens in a new tab)DOI10.1016/s0140-6736(13)60856-9 (opens in a new tab)PepBankPUB-23683600
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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 study9

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In women with postmenopausal osteoporosis, teriparatide plus denosumab increased lumbar spine BMD more than denosumab alone.

    In plain wordsIn women with osteoporosis, teriparatide plus denosumab increased lumbar bone density more than denosumab alone.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseLumbar spine BMD
    Study

    n: not reported in source

    Comparator
    Denosumab alone
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg dailyAs given in this study (human).

    Measurements

    Lumbar spine BMD increase
    9.1%
    teriparatide plus denosumab at 12 months
    Lumbar spine BMD increase SD
    3.9%
    teriparatide plus denosumab SD
    Lumbar spine BMD increase
    5.5%
    denosumab alone at 12 months
    Lumbar spine BMD increase SD
    3.3%
    denosumab alone SD

    Source sentences

    Summary
    At 12 months, posterior-anterior lumbar spine BMD increased more in the combination group (9·1%, [SD 3·9]) than in the teriparatide (6·2% [4·6], p=0·0139) or denosumab (5·5% [3·3], p=0·0005) groups.
    3 context sentences
    Summary · context
    From September, 2009, to January, 2011, we enrolled postmenopausal women with osteoporosis into this randomised, controlled trial.
    Summary · context
    Patients were assigned in a 1:1:1 ratio to receive 20 μg teriparatide daily, 60 mg denosumab every 6 months, or both.
    Summary · context
    Women who completed at least one study visit after baseline were assessed in a modified intention-to-treat analysis.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In women with postmenopausal osteoporosis, teriparatide plus denosumab increased femoral neck BMD more than denosumab alone.

    In plain wordsIn women with osteoporosis, teriparatide plus denosumab increased femoral neck bone density more than denosumab alone.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseFemoral neck BMD
    Study

    n: not reported in source

    Comparator
    Denosumab alone
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg dailyAs given in this study (human).

    Measurements

    Femoral neck BMD increase
    4.2%
    teriparatide plus denosumab at 12 months
    Femoral neck BMD increase SD
    3%
    teriparatide plus denosumab SD
    Femoral neck BMD increase
    2.1%
    denosumab alone at 12 months
    Femoral neck BMD increase SD
    3.8%
    denosumab alone SD

    Source sentences

    Summary
    Femoral-neck BMD also increased more in the combination group (4·2% [3·0]) than in the teriparatide (0·8% [4·1], p=0·0007) and denosumab (2·1% [3·8], p=0·0238) groups, as did total-hip BMD (combination, 4·9% [2·9]; teriparatide, 0·7% [2·7], p<0·0001; denosumab 2·5% [2·6], p=0·0011).
    3 context sentences
    Summary · context
    From September, 2009, to January, 2011, we enrolled postmenopausal women with osteoporosis into this randomised, controlled trial.
    Summary · context
    Patients were assigned in a 1:1:1 ratio to receive 20 μg teriparatide daily, 60 mg denosumab every 6 months, or both.
    Summary · context
    Women who completed at least one study visit after baseline were assessed in a modified intention-to-treat analysis.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In women with postmenopausal osteoporosis, teriparatide plus denosumab increased total hip BMD more than denosumab alone.

    In plain wordsIn women with osteoporosis, teriparatide plus denosumab increased total hip bone density more than denosumab alone.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseTotal hip BMD
    Study

    n: not reported in source

    Comparator
    Denosumab alone
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg dailyAs given in this study (human).

    Measurements

    Total hip BMD increase
    4.9%
    teriparatide plus denosumab at 12 months
    Total hip BMD increase SD
    2.9%
    teriparatide plus denosumab SD
    Total hip BMD increase
    2.5%
    denosumab alone at 12 months
    Total hip BMD increase SD
    2.6%
    denosumab alone SD

    Source sentences

    Summary
    Femoral-neck BMD also increased more in the combination group (4·2% [3·0]) than in the teriparatide (0·8% [4·1], p=0·0007) and denosumab (2·1% [3·8], p=0·0238) groups, as did total-hip BMD (combination, 4·9% [2·9]; teriparatide, 0·7% [2·7], p<0·0001; denosumab 2·5% [2·6], p=0·0011).
    3 context sentences
    Summary · context
    From September, 2009, to January, 2011, we enrolled postmenopausal women with osteoporosis into this randomised, controlled trial.
    Summary · context
    Patients were assigned in a 1:1:1 ratio to receive 20 μg teriparatide daily, 60 mg denosumab every 6 months, or both.
    Summary · context
    Women who completed at least one study visit after baseline were assessed in a modified intention-to-treat analysis.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In women with postmenopausal osteoporosis, lumbar spine BMD increased by 6·2% at 12 months in the teriparatide-alone group.

    In plain wordsIn women with osteoporosis, lumbar spine bone density increased during teriparatide alone compared with baseline.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseLumbar spine BMD with teriparatide alone
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg dailyAs given in this study (human).

    Measurements

    Lumbar spine BMD increase
    6.2%
    teriparatide alone at 12 months
    Lumbar spine BMD increase SD
    4.6%
    teriparatide alone SD

    Source sentences

    Summary
    At 12 months, posterior-anterior lumbar spine BMD increased more in the combination group (9·1%, [SD 3·9]) than in the teriparatide (6·2% [4·6], p=0·0139) or denosumab (5·5% [3·3], p=0·0005) groups.
    1 context sentence
    Summary · context
    From September, 2009, to January, 2011, we enrolled postmenopausal women with osteoporosis into this randomised, controlled trial. Patients were assigned in a 1:1:1 ratio to receive 20 μg teriparatide daily, 60 mg denosumab every 6 months, or both.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In women with postmenopausal osteoporosis, femoral neck BMD increased by 0·8% at 12 months in the teriparatide-alone group.

    In plain wordsIn women with osteoporosis, femoral neck bone density increased during teriparatide alone compared with baseline.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseFemoral neck BMD with teriparatide alone
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg dailyAs given in this study (human).

    Measurements

    Femoral neck BMD increase
    0.8%
    teriparatide alone at 12 months
    Femoral neck BMD increase SD
    4.1%
    teriparatide alone SD

    Source sentences

    Summary
    Femoral-neck BMD also increased more in the combination group (4·2% [3·0]) than in the teriparatide (0·8% [4·1], p=0·0007) and denosumab (2·1% [3·8], p=0·0238) groups, as did total-hip BMD (combination, 4·9% [2·9]; teriparatide, 0·7% [2·7], p<0·0001; denosumab 2·5% [2·6], p=0·0011).
    2 context sentences
    Summary · context
    At 12 months, posterior-anterior lumbar spine BMD increased more in the combination group (9·1%, [SD 3·9]) than in the teriparatide (6·2% [4·6], p=0·0139) or denosumab (5·5% [3·3], p=0·0005) groups.
    Summary · context
    From September, 2009, to January, 2011, we enrolled postmenopausal women with osteoporosis into this randomised, controlled trial. Patients were assigned in a 1:1:1 ratio to receive 20 μg teriparatide daily, 60 mg denosumab every 6 months, or both.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In women with postmenopausal osteoporosis, total hip BMD increased by 0·7% after 12 months of teriparatide alone.

    In plain wordsIn women with osteoporosis, total hip bone density increased during teriparatide alone compared with baseline.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseTotal hip BMD with teriparatide alone
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg daily · 12 monthsAs given in this study (human).

    Measurements

    Total hip BMD increase
    0.7%
    teriparatide alone at 12 months

    Source sentences

    Summary
    Femoral-neck BMD also increased more in the combination group (4·2% [3·0]) than in the teriparatide (0·8% [4·1], p=0·0007) and denosumab (2·1% [3·8], p=0·0238) groups, as did total-hip BMD (combination, 4·9% [2·9]; teriparatide, 0·7% [2·7], p<0·0001; denosumab 2·5% [2·6], p=0·0011).
    2 context sentences
    Summary · context
    At 12 months, posterior-anterior lumbar spine BMD increased more in the combination group (9·1%, [SD 3·9]) than in the teriparatide (6·2% [4·6], p=0·0139) or denosumab (5·5% [3·3], p=0·0005) groups.
    Summary · context
    From September, 2009, to January, 2011, we enrolled postmenopausal women with osteoporosis into this randomised, controlled trial. Patients were assigned in a 1:1:1 ratio to receive 20 μg teriparatide daily, 60 mg denosumab every 6 months, or both.

Studies that did not test the peptide alone3

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).

  1. 07HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In women with postmenopausal osteoporosis, teriparatide plus denosumab increased lumbar spine BMD more than teriparatide alone.

    In plain wordsIn women with osteoporosis, teriparatide plus denosumab increased lumbar bone density more than teriparatide alone.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseLumbar spine BMD
    Study

    n: not reported in source

    Comparator
    Teriparatide alone
    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    Lumbar spine BMD increase
    9.1%
    teriparatide plus denosumab at 12 months
    Lumbar spine BMD increase SD
    3.9%
    teriparatide plus denosumab SD
    Lumbar spine BMD increase
    6.2%
    teriparatide alone at 12 months
    Lumbar spine BMD increase SD
    4.6%
    teriparatide alone SD

    Source sentences

    Summary
    At 12 months, posterior-anterior lumbar spine BMD increased more in the combination group (9·1%, [SD 3·9]) than in the teriparatide (6·2% [4·6], p=0·0139) or denosumab (5·5% [3·3], p=0·0005) groups.
    3 context sentences
    Summary · context
    From September, 2009, to January, 2011, we enrolled postmenopausal women with osteoporosis into this randomised, controlled trial.
    Summary · context
    Patients were assigned in a 1:1:1 ratio to receive 20 μg teriparatide daily, 60 mg denosumab every 6 months, or both.
    Summary · context
    Women who completed at least one study visit after baseline were assessed in a modified intention-to-treat 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).

  2. 08HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In women with postmenopausal osteoporosis, teriparatide plus denosumab increased femoral neck BMD more than teriparatide alone.

    In plain wordsIn women with osteoporosis, teriparatide plus denosumab increased femoral neck bone density more than teriparatide alone.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseFemoral neck BMD
    Study

    n: not reported in source

    Comparator
    Teriparatide alone
    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    Femoral neck BMD increase
    4.2%
    teriparatide plus denosumab at 12 months
    Femoral neck BMD increase SD
    3%
    teriparatide plus denosumab SD
    Femoral neck BMD increase
    0.8%
    teriparatide alone at 12 months
    Femoral neck BMD increase SD
    4.1%
    teriparatide alone SD

    Source sentences

    Summary
    Femoral-neck BMD also increased more in the combination group (4·2% [3·0]) than in the teriparatide (0·8% [4·1], p=0·0007) and denosumab (2·1% [3·8], p=0·0238) groups, as did total-hip BMD (combination, 4·9% [2·9]; teriparatide, 0·7% [2·7], p<0·0001; denosumab 2·5% [2·6], p=0·0011).
    3 context sentences
    Summary · context
    From September, 2009, to January, 2011, we enrolled postmenopausal women with osteoporosis into this randomised, controlled trial.
    Summary · context
    Patients were assigned in a 1:1:1 ratio to receive 20 μg teriparatide daily, 60 mg denosumab every 6 months, or both.
    Summary · context
    Women who completed at least one study visit after baseline were assessed in a modified intention-to-treat 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).

  3. 09HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In women with postmenopausal osteoporosis, teriparatide plus denosumab increased total hip BMD more than teriparatide alone.

    In plain wordsIn women with osteoporosis, teriparatide plus denosumab increased total hip bone density more than teriparatide alone.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseTotal hip BMD
    Study

    n: not reported in source

    Comparator
    Teriparatide alone
    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    Total hip BMD increase
    4.9%
    teriparatide plus denosumab at 12 months
    Total hip BMD increase SD
    2.9%
    teriparatide plus denosumab SD
    Total hip BMD increase
    0.7%
    teriparatide alone at 12 months
    Total hip BMD increase SD
    2.7%
    teriparatide alone SD

    Source sentences

    Summary
    Femoral-neck BMD also increased more in the combination group (4·2% [3·0]) than in the teriparatide (0·8% [4·1], p=0·0007) and denosumab (2·1% [3·8], p=0·0238) groups, as did total-hip BMD (combination, 4·9% [2·9]; teriparatide, 0·7% [2·7], p<0·0001; denosumab 2·5% [2·6], p=0·0011).
    3 context sentences
    Summary · context
    From September, 2009, to January, 2011, we enrolled postmenopausal women with osteoporosis into this randomised, controlled trial.
    Summary · context
    Patients were assigned in a 1:1:1 ratio to receive 20 μg teriparatide daily, 60 mg denosumab every 6 months, or both.
    Summary · context
    Women who completed at least one study visit after baseline were assessed in a modified intention-to-treat 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).

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 postedNCT00926380

Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis

Massachusetts General Hospitaln = 94Jun 2009 to Dec 2016

Osteoporosis

Trial pageClinicalTrials.govUpdated 29 Jun 2018

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.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. 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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