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Study · Randomized controlled trial · n = 60 · 2020

6 results

Bone Mineral Density Response With Denosumab in Combination With Standard or High-Dose Teriparatide: The DATA-HD RCT.

Ramchand SK, David NL, Leder BZ, Tsai JN

The Journal of clinical endocrinology and metabolism1 Mar 2020Cited by 10 (Europe PMC)

PMID31674641 (opens in a new tab)PMCIDPMC7112977 (opens in a new tab)DOI10.1210/clinem/dgz163 (opens in a new tab)PepBankPUB-31674641
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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 study6

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with osteoporosis receiving denosumab, high-dose teriparatide produced more total hip aBMD responses >3% than standard-dose teriparatide.

    In plain wordsIn postmenopausal women receiving denosumab, high-dose teriparatide produced more hip bone density responses >3% than standard-dose teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseTotal hip aBMD response >3%
    Study

    n = 60

    Comparator
    Teriparatide 20 μg daily with denosumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    40 μg daily · Months 0 through 9As given in this study (human).

    Measurements

    Total hip response >3%
    83%
    high-dose teriparatide
    Total hip response >3%
    58%
    standard-dose teriparatide

    Source sentences

    Summary
    At the end of the 15-month treatment period, a higher proportion of women in the HD group had aBMD increases >3% (83% vs. 58%, P = .037) and >6% (45% vs. 19%, P = .034) at the total hip, and >3% at the femoral neck (86% vs. 63%, P = .044).
    2 context sentences
    Summary · context
    Single-site, open-label, randomized controlled trial in which postmenopausal women received either teriparatide 20-μg daily (SD) or 40-μg daily (HD) given months 0 through 9, overlapped with denosumab 60 mg, given months 3 through 15 (15 months' total duration).
    Summary · context
    Postmenopausal women with osteoporosis completing all study visits (n = 60).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with osteoporosis receiving denosumab, high-dose teriparatide produced more total hip aBMD responses >6% than standard-dose teriparatide.

    In plain wordsIn postmenopausal women receiving denosumab, high-dose teriparatide produced more hip bone density responses >6% than standard-dose teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseTotal hip aBMD response >6%
    Study

    n = 60

    Comparator
    Teriparatide 20 μg daily with denosumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    40 μg daily · Months 0 through 9As given in this study (human).

    Measurements

    Total hip response >6%
    45%
    high-dose teriparatide
    Total hip response >6%
    19%
    standard-dose teriparatide

    Source sentences

    Summary
    At the end of the 15-month treatment period, a higher proportion of women in the HD group had aBMD increases >3% (83% vs. 58%, P = .037) and >6% (45% vs. 19%, P = .034) at the total hip, and >3% at the femoral neck (86% vs. 63%, P = .044).
    2 context sentences
    Summary · context
    Single-site, open-label, randomized controlled trial in which postmenopausal women received either teriparatide 20-μg daily (SD) or 40-μg daily (HD) given months 0 through 9, overlapped with denosumab 60 mg, given months 3 through 15 (15 months' total duration).
    Summary · context
    Postmenopausal women with osteoporosis completing all study visits (n = 60).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with osteoporosis receiving denosumab, high-dose teriparatide produced more femoral neck aBMD responses >3% than standard-dose teriparatide.

    In plain wordsIn postmenopausal women receiving denosumab, high-dose teriparatide produced more femoral neck bone density responses >3% than standard-dose teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseFemoral neck aBMD response >3%
    Study

    n = 60

    Comparator
    Teriparatide 20 μg daily with denosumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    40 μg daily · Months 0 through 9As given in this study (human).

    Measurements

    Femoral neck response >3%
    86%
    high-dose teriparatide
    Femoral neck response >3%
    63%
    standard-dose teriparatide

    Source sentences

    Summary
    At the end of the 15-month treatment period, a higher proportion of women in the HD group had aBMD increases >3% (83% vs. 58%, P = .037) and >6% (45% vs. 19%, P = .034) at the total hip, and >3% at the femoral neck (86% vs. 63%, P = .044).
    2 context sentences
    Summary · context
    Single-site, open-label, randomized controlled trial in which postmenopausal women received either teriparatide 20-μg daily (SD) or 40-μg daily (HD) given months 0 through 9, overlapped with denosumab 60 mg, given months 3 through 15 (15 months' total duration).
    Summary · context
    Postmenopausal women with osteoporosis completing all study visits (n = 60).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with osteoporosis receiving denosumab, lumbar spine aBMD response rates >3% were similar with high-dose and standard-dose teriparatide.

    In plain wordsIn postmenopausal women receiving denosumab, lumbar bone density response rates >3% were similar with high-dose and standard-dose teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeLumbar spine aBMD response >3%
    Study

    n = 60

    Comparator
    Teriparatide 20 μg daily with denosumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    40 μg daily · Months 0 through 9As given in this study (human).

    Source sentences

    Summary
    At the lumbar spine, >3% response rates were similar, whereas the >6% and >9% response rates were greater in the HD group (100% vs. 79%, P = .012 and 93% vs. 59%, P = .003, respectively).
    2 context sentences
    Summary · context
    Single-site, open-label, randomized controlled trial in which postmenopausal women received either teriparatide 20-μg daily (SD) or 40-μg daily (HD) given months 0 through 9, overlapped with denosumab 60 mg, given months 3 through 15 (15 months' total duration).
    Summary · context
    Postmenopausal women with osteoporosis completing all study visits (n = 60).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with osteoporosis receiving denosumab, high-dose teriparatide produced more lumbar spine aBMD responses >6% than standard-dose teriparatide.

    In plain wordsIn postmenopausal women receiving denosumab, high-dose teriparatide produced more lumbar bone density responses >6% than standard-dose teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseLumbar spine aBMD response >6%
    Study

    n = 60

    Comparator
    Teriparatide 20 μg daily with denosumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    40 μg daily · Months 0 through 9As given in this study (human).

    Measurements

    Lumbar spine response >6%
    100%
    high-dose teriparatide
    Lumbar spine response >6%
    79%
    standard-dose teriparatide

    Source sentences

    Summary
    At the lumbar spine, >3% response rates were similar, whereas the >6% and >9% response rates were greater in the HD group (100% vs. 79%, P = .012 and 93% vs. 59%, P = .003, respectively).
    2 context sentences
    Summary · context
    Single-site, open-label, randomized controlled trial in which postmenopausal women received either teriparatide 20-μg daily (SD) or 40-μg daily (HD) given months 0 through 9, overlapped with denosumab 60 mg, given months 3 through 15 (15 months' total duration).
    Summary · context
    Postmenopausal women with osteoporosis completing all study visits (n = 60).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with osteoporosis receiving denosumab, high-dose teriparatide produced more lumbar spine aBMD responses >9% than standard-dose teriparatide.

    In plain wordsIn postmenopausal women receiving denosumab, high-dose teriparatide produced more lumbar bone density responses >9% than standard-dose teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseLumbar spine aBMD response >9%
    Study

    n = 60

    Comparator
    Teriparatide 20 μg daily with denosumab
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    40 μg daily · Months 0 through 9As given in this study (human).

    Measurements

    Lumbar spine response >9%
    93%
    high-dose teriparatide
    Lumbar spine response >9%
    59%
    standard-dose teriparatide

    Source sentences

    Summary
    At the lumbar spine, >3% response rates were similar, whereas the >6% and >9% response rates were greater in the HD group (100% vs. 79%, P = .012 and 93% vs. 59%, P = .003, respectively).
    2 context sentences
    Summary · context
    Single-site, open-label, randomized controlled trial in which postmenopausal women received either teriparatide 20-μg daily (SD) or 40-μg daily (HD) given months 0 through 9, overlapped with denosumab 60 mg, given months 3 through 15 (15 months' total duration).
    Summary · context
    Postmenopausal women with osteoporosis completing all study visits (n = 60).

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 pageClinicalTrials.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.

  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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