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Study · Randomized controlled trial · 2014

11 results

Two years of Denosumab and teriparatide administration in postmenopausal women with osteoporosis (The DATA Extension Study): a randomized controlled trial.

Leder BZ, Tsai JN, Uihlein AV, Burnett-Bowie SA, Zhu Y, Foley K, Lee H, Neer RM

The Journal of clinical endocrinology and metabolism11 Feb 2014Cited by 196 (Europe PMC)

PMID24517156 (opens in a new tab)PMCIDPMC4010689 (opens in a new tab)DOI10.1210/jc.2013-4440 (opens in a new tab)PepBankPUB-24517156
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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 study11

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, adding teriparatide to denosumab increased spine BMD 12.9% versus 8.3% with denosumab alone.

    In plain wordsIn postmenopausal osteoporosis, adding teriparatide increased spine bone density more than denosumab alone.

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

    n: not reported in source

    Comparator
    Denosumab alone
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg daily · 24 monthsAs given in this study (human).

    Measurements

    Lumbar spine BMD increase
    12.9%
    denosumab plus teriparatide
    Lumbar spine BMD increase
    8.3%
    denosumab alone

    Source sentences

    Summary
    At 24 months, lumbar spine BMD increased more in the combination group (12.9 ± 5.0%) than in either the teriparatide (9.5 ± 5.9%, P = .01) or denosumab (8.3 ± 3.4%, P = .008) groups.
    2 context sentences
    Summary · context
    Preplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months.
    Summary · context
    Participants were 94 postmenopausal women with osteoporosis.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, adding teriparatide to denosumab increased femoral neck BMD 6.8% versus 4.1% with denosumab alone.

    In plain wordsIn postmenopausal osteoporosis, adding teriparatide increased femoral neck bone density more than denosumab alone.

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

    n: not reported in source

    Comparator
    Denosumab alone
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg daily · 24 monthsAs given in this study (human).

    Measurements

    Femoral neck BMD increase
    6.8%
    denosumab plus teriparatide
    Femoral neck BMD increase
    4.1%
    denosumab alone

    Source sentences

    Summary
    Femoral neck BMD also increased more in the combination group (6.8 ± 3.6%) than in either the teriparatide (2.8 ± 3.9%, P = .003) or denosumab (4.1 ± 3.8%, P = .008) groups.
    2 context sentences
    Summary · context
    Preplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months.
    Summary · context
    Participants were 94 postmenopausal women with osteoporosis.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, adding teriparatide to denosumab increased total hip BMD 6.3% versus 3.2% with denosumab alone.

    In plain wordsIn postmenopausal osteoporosis, adding teriparatide increased total hip bone density more than denosumab alone.

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

    n: not reported in source

    Comparator
    Denosumab alone
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg daily · 24 monthsAs given in this study (human).

    Measurements

    Total hip BMD increase
    6.3%
    denosumab plus teriparatide
    Total hip BMD increase
    3.2%
    denosumab alone

    Source sentences

    Summary
    Similarly, total hip BMD increased more in the combination group (6.3 ± 2.6%) than in the teriparatide (2.0 ± 3.0%) or denosumab (3.2 ± 2.5%) groups (P < .001 for both).
    2 context sentences
    Summary · context
    Preplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months.
    Summary · context
    Participants were 94 postmenopausal women with osteoporosis.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, serum C-telopeptide was equally suppressed with denosumab plus teriparatide and denosumab alone.

    In plain wordsIn postmenopausal osteoporosis, a bone breakdown marker was equally suppressed with the combination and denosumab alone.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeSerum C-telopeptide
    Study

    n: not reported in source

    Comparator
    Denosumab alone
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg daily · 24 monthsAs given in this study (human).

    Source sentences

    Summary
    Serum C-telopeptide and N-terminal propeptide of type 1 procollagen were equally suppressed in the denosumab and combination groups,
    2 context sentences
    Summary · context
    Preplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months.
    Summary · context
    Participants were 94 postmenopausal women with osteoporosis.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, P1NP was equally suppressed with denosumab plus teriparatide and denosumab alone.

    In plain wordsIn postmenopausal osteoporosis, a bone formation marker was equally suppressed with the combination and denosumab alone.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeSerum P1NP
    Study

    n: not reported in source

    Comparator
    Denosumab alone
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg daily · 24 monthsAs given in this study (human).

    Source sentences

    Summary
    Serum C-telopeptide and N-terminal propeptide of type 1 procollagen were equally suppressed in the denosumab and combination groups,
    2 context sentences
    Summary · context
    Preplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months.
    Summary · context
    Participants were 94 postmenopausal women with osteoporosis.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, osteocalcin decreased less with denosumab plus teriparatide than denosumab alone, with a smaller difference in year two.

    In plain wordsIn postmenopausal osteoporosis, osteocalcin decreased less with the combination than denosumab alone.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseOsteocalcin
    Study

    n: not reported in source

    Comparator
    Denosumab alone
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 μg daily · 24 monthsAs given in this study (human).

    Source sentences

    Summary
    whereas osteocalcin decreased more in the denosumab group than in the combination group, a difference that persisted, but lessened, in the second year of therapy.
    2 context sentences
    Summary · context
    Preplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months.
    Summary · context
    Participants were 94 postmenopausal women with osteoporosis.

Studies that did not test the peptide alone5

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 postmenopausal osteoporosis, second-year spine BMD increases did not differ among teriparatide, denosumab and combination groups.

    In plain wordsSecond-year spine bone density increases were similar across teriparatide, denosumab and combination groups.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeSecond-year spine BMD changes across regimens
    Study

    n = 94

    Comparator
    Teriparatide, denosumab and combination groups
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    Although spine and hip BMD continued to increase in the second year in all groups, these year 2 increases did not differ among groups.
    2 context sentences
    Summary · context
    Preplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months.
    Summary · context
    Participants were 94 postmenopausal women with osteoporosis.

    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 postmenopausal osteoporosis, second-year hip BMD increases did not differ among teriparatide, denosumab and combination groups.

    In plain wordsSecond-year hip bone density increases were similar across teriparatide, denosumab and combination groups.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeSecond-year hip BMD changes across regimens
    Study

    n = 94

    Comparator
    Teriparatide, denosumab and combination groups
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    Although spine and hip BMD continued to increase in the second year in all groups, these year 2 increases did not differ among groups.
    2 context sentences
    Summary · context
    Preplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months.
    Summary · context
    Participants were 94 postmenopausal women with osteoporosis.

    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 postmenopausal osteoporosis, denosumab plus teriparatide increased spine BMD 12.9% versus 9.5% with teriparatide alone.

    In plain wordsIn postmenopausal osteoporosis, denosumab plus teriparatide increased spine bone density more than teriparatide alone.

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

    n: not reported in source

    Comparator
    Teriparatide alone
    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    Lumbar spine BMD increase
    12.9%
    denosumab plus teriparatide
    Lumbar spine BMD increase
    9.5%
    teriparatide alone

    Source sentences

    Summary
    At 24 months, lumbar spine BMD increased more in the combination group (12.9 ± 5.0%) than in either the teriparatide (9.5 ± 5.9%, P = .01) or denosumab (8.3 ± 3.4%, P = .008) groups.
    2 context sentences
    Summary · context
    Preplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months.
    Summary · context
    Participants were 94 postmenopausal women with osteoporosis.

    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).

  4. 10HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, denosumab plus teriparatide increased femoral neck BMD 6.8% versus 2.8% with teriparatide alone.

    In plain wordsIn postmenopausal osteoporosis, the combination increased femoral neck bone density more than teriparatide alone.

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

    n: not reported in source

    Comparator
    Teriparatide alone
    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    Femoral neck BMD increase
    6.8%
    denosumab plus teriparatide
    Femoral neck BMD increase
    2.8%
    teriparatide alone

    Source sentences

    Summary
    Femoral neck BMD also increased more in the combination group (6.8 ± 3.6%) than in either the teriparatide (2.8 ± 3.9%, P = .003) or denosumab (4.1 ± 3.8%, P = .008) groups.
    2 context sentences
    Summary · context
    Preplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months.
    Summary · context
    Participants were 94 postmenopausal women with osteoporosis.

    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).

  5. 11HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialEfficacy outcome

    In postmenopausal osteoporosis, denosumab plus teriparatide increased total hip BMD 6.3% versus 2.0% with teriparatide alone.

    In plain wordsIn postmenopausal osteoporosis, the combination increased total hip bone density more than teriparatide alone.

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

    n: not reported in source

    Comparator
    Teriparatide alone
    Outcome group
    Bone and joint · Musculoskeletal

    Measurements

    Total hip BMD increase
    6.3%
    denosumab plus teriparatide
    Total hip BMD increase
    2%
    teriparatide alone

    Source sentences

    Summary
    Similarly, total hip BMD increased more in the combination group (6.3 ± 2.6%) than in the teriparatide (2.0 ± 3.0%) or denosumab (3.2 ± 2.5%) groups (P < .001 for both).
    2 context sentences
    Summary · context
    Preplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months.
    Summary · context
    Participants were 94 postmenopausal women with osteoporosis.

    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 ongoing · source ClinicalTrials.gov (opens in a new tab)

Active, not recruitingPhase 4NCT04467983

Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone

Hospital for Special Surgery, New Yorkn = 701 Feb 2021 to est. 31 Dec 2026

Osteoporosis, Postmenopausal

Trial pageClinicalTrials.govUpdated 13 Oct 2026

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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