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Study · Randomized controlled trial · n = 41 · 2020

10 results

Effect of Teriparatide on Bone Remodeling and Density in Premenopausal Idiopathic Osteoporosis: A Phase II Trial.

Cohen A, Shiau S, Nair N, Recker RR, Lappe JM, Dempster DW, Nickolas TL, Zhou H, Agarwal S, Kamanda-Kosseh M, Bucovsky M, Williams JM, McMahon DJ, Stubby J, Shane E

The Journal of clinical endocrinology and metabolism1 Oct 2020Cited by 30 (Europe PMC)

PMID32876328 (opens in a new tab)PMCIDPMC8921657 (opens in a new tab)DOI10.1210/clinem/dgaa489 (opens in a new tab)PepBankPUB-32876328
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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

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In premenopausal women with idiopathic osteoporosis, lumbar spine BMD increased 5.5% with teriparatide versus 1.5% with placebo over 6 months.

    In plain wordsIn premenopausal women with idiopathic osteoporosis, teriparatide increased lumbar spine bone density more than placebo over 6 months.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseLumbar spine areal BMD at 6 months
    Study

    n = 41

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 mcg · 6 monthsAs given in this study (human).

    Measurements

    Lumbar spine aBMD change
    5.5%
    teriparatide over 6 months
    Lumbar spine aBMD change
    1.5%
    placebo over 6 months

    Source sentences

    Summary
    Over 6M, LS aBMD increased by 5.5% (95% CI: 3.83, 7.19) in teriparatide and 1.5% (95% CI: -0.73, 3.83) in placebo (P = 0.007).
    4 context sentences
    Summary · context
    6M phase 2 randomized controlled trial (RCT) followed by open extension.
    Summary · context
    Premenopausal women with IOP.
    Summary · context
    A total of 41 women were randomized to either teriparatide 20 mcg (n = 28) or placebo (n = 13).
    Summary · context
    After 6M, those on placebo switched to teriparatide for 24M; those on teriparatide continued for 18M.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In premenopausal women with idiopathic osteoporosis, teriparatide increased cancellous bone formation rate compared with placebo at 3 months.

    In plain wordsIn premenopausal women with idiopathic osteoporosis, teriparatide increased cancellous bone formation more than placebo at 3 months.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseCancellous bone formation rate at 3 months
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 mcg · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    There were increases in 3M BTMs, and BFR (cancellous and endocortical BFR: between-groups P = 0.004).
    4 context sentences
    Summary · context
    6M phase 2 randomized controlled trial (RCT) followed by open extension.
    Summary · context
    Premenopausal women with IOP.
    Summary · context
    A total of 41 women were randomized to either teriparatide 20 mcg (n = 28) or placebo (n = 13).
    Summary · context
    After 6M, those on placebo switched to teriparatide for 24M; those on teriparatide continued for 18M.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In premenopausal women with idiopathic osteoporosis, teriparatide increased endocortical bone formation rate compared with placebo at 3 months.

    In plain wordsIn premenopausal women with idiopathic osteoporosis, teriparatide increased inner-surface bone formation more than placebo at 3 months.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseEndocortical bone formation rate at 3 months
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 mcg · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    There were increases in 3M BTMs, and BFR (cancellous and endocortical BFR: between-groups P = 0.004).
    4 context sentences
    Summary · context
    6M phase 2 randomized controlled trial (RCT) followed by open extension.
    Summary · context
    Premenopausal women with IOP.
    Summary · context
    A total of 41 women were randomized to either teriparatide 20 mcg (n = 28) or placebo (n = 13).
    Summary · context
    After 6M, those on placebo switched to teriparatide for 24M; those on teriparatide continued for 18M.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In premenopausal women with idiopathic osteoporosis, bone turnover markers increased at 3 months during the teriparatide trial.

    In plain wordsIn premenopausal women with idiopathic osteoporosis, bone turnover markers increased at 3 months during the teriparatide trial.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseBone turnover markers at 3 months
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 mcg · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    There were increases in 3M BTMs, and BFR (cancellous and endocortical BFR: between-groups P = 0.004).
    4 context sentences
    Summary · context
    6M phase 2 randomized controlled trial (RCT) followed by open extension.
    Summary · context
    Premenopausal women with IOP.
    Summary · context
    A total of 41 women were randomized to either teriparatide 20 mcg (n = 28) or placebo (n = 13).
    Summary · context
    After 6M, those on placebo switched to teriparatide for 24M; those on teriparatide continued for 18M.
  5. 05HumanRandomized controlled trialSafety outcome

    In premenopausal women with idiopathic osteoporosis, teriparatide was well tolerated.

    In plain wordsIn premenopausal women with idiopathic osteoporosis, teriparatide was well tolerated.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    Not applicableTolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    20 mcgAs given in this study (human).

    Source sentences

    Summary
    Teriparatide was well-tolerated.
    4 context sentences
    Summary · context
    6M phase 2 randomized controlled trial (RCT) followed by open extension.
    Summary · context
    Premenopausal women with IOP.
    Summary · context
    A total of 41 women were randomized to either teriparatide 20 mcg (n = 28) or placebo (n = 13).
    Summary · context
    After 6M, those on placebo switched to teriparatide for 24M; those on teriparatide continued for 18M.
  6. 06HumanNon-randomized trialEfficacy outcome

    In the open extension in premenopausal women with idiopathic osteoporosis, teriparatide increased lumbar spine BMD by 13.2% over 24 months.

    In plain wordsIn premenopausal women with idiopathic osteoporosis, lumbar spine bone density increased from baseline during 24 months of teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseLumbar spine areal BMD at 24 months
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 mcg · 24 monthsAs given in this study (human).

    Measurements

    Lumbar spine aBMD change
    13.2%
    teriparatide over 24 months

    Source sentences

    Summary
    Over 24M, teriparatide increased LS aBMD by 13.2% (95% CI: 10.3, 16.2), total hip by 5.2% (95% CI: 3.7, 6.7) and femoral neck by 5.0% (95% CI: 3.2, 6.7; all P ≤ 0.001).
    4 context sentences
    Summary · context
    6M phase 2 randomized controlled trial (RCT) followed by open extension.
    Summary · context
    Premenopausal women with IOP.
    Summary · context
    A total of 41 women were randomized to either teriparatide 20 mcg (n = 28) or placebo (n = 13).
    Summary · context
    After 6M, those on placebo switched to teriparatide for 24M; those on teriparatide continued for 18M.
  7. 07HumanNon-randomized trialEfficacy outcome

    In the open extension in premenopausal women with idiopathic osteoporosis, teriparatide increased total hip BMD by 5.2% over 24 months.

    In plain wordsIn premenopausal women with idiopathic osteoporosis, total hip bone density increased from baseline during 24 months of teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseTotal hip areal BMD at 24 months
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 mcg · 24 monthsAs given in this study (human).

    Measurements

    Total hip aBMD change
    5.2%
    teriparatide over 24 months

    Source sentences

    Summary
    Over 24M, teriparatide increased LS aBMD by 13.2% (95% CI: 10.3, 16.2), total hip by 5.2% (95% CI: 3.7, 6.7) and femoral neck by 5.0% (95% CI: 3.2, 6.7; all P ≤ 0.001).
    4 context sentences
    Summary · context
    6M phase 2 randomized controlled trial (RCT) followed by open extension.
    Summary · context
    Premenopausal women with IOP.
    Summary · context
    A total of 41 women were randomized to either teriparatide 20 mcg (n = 28) or placebo (n = 13).
    Summary · context
    After 6M, those on placebo switched to teriparatide for 24M; those on teriparatide continued for 18M.
  8. 08HumanNon-randomized trialEfficacy outcome

    In the open extension in premenopausal women with idiopathic osteoporosis, teriparatide increased femoral neck BMD by 5.0% over 24 months.

    In plain wordsIn premenopausal women with idiopathic osteoporosis, femoral neck bone density increased from baseline during 24 months of teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseFemoral neck areal BMD at 24 months
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 mcg · 24 monthsAs given in this study (human).

    Measurements

    Femoral neck aBMD change
    5%
    teriparatide over 24 months

    Source sentences

    Summary
    Over 24M, teriparatide increased LS aBMD by 13.2% (95% CI: 10.3, 16.2), total hip by 5.2% (95% CI: 3.7, 6.7) and femoral neck by 5.0% (95% CI: 3.2, 6.7; all P ≤ 0.001).
    4 context sentences
    Summary · context
    6M phase 2 randomized controlled trial (RCT) followed by open extension.
    Summary · context
    Premenopausal women with IOP.
    Summary · context
    A total of 41 women were randomized to either teriparatide 20 mcg (n = 28) or placebo (n = 13).
    Summary · context
    After 6M, those on placebo switched to teriparatide for 24M; those on teriparatide continued for 18M.

Studies that did not test the peptide alone2

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. 09HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyOther

    In premenopausal women with idiopathic osteoporosis, serum P1NP was moderately associated with lumbar spine BMD response to teriparatide.

    In plain wordsIn premenopausal women with idiopathic osteoporosis, serum P1NP was moderately linked to lumbar spine bone density response to teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    Not applicableP1NP association with lumbar spine BMD response
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    Serum N-terminal propeptides of procollagen type 1 (P1NP) and 3M endocortical BFR were moderately associated with LS aBMD response.
    4 context sentences
    Summary · context
    6M phase 2 randomized controlled trial (RCT) followed by open extension.
    Summary · context
    Premenopausal women with IOP.
    Summary · context
    A total of 41 women were randomized to either teriparatide 20 mcg (n = 28) or placebo (n = 13).
    Summary · context
    After 6M, those on placebo switched to teriparatide for 24M; those on teriparatide continued for 18M.

    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. 10HumanNot a test of Teriparatide (PTH 1-34) aloneObservational studyOther

    In premenopausal women with idiopathic osteoporosis, endocortical bone formation rate at 3 months was moderately associated with lumbar BMD response to teriparatide.

    In plain wordsIn premenopausal women with idiopathic osteoporosis, inner-surface bone formation was moderately linked to lumbar bone density response to teriparatide.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    Not applicableEndocortical bone formation association with lumbar spine BMD response
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    Serum N-terminal propeptides of procollagen type 1 (P1NP) and 3M endocortical BFR were moderately associated with LS aBMD response.
    4 context sentences
    Summary · context
    6M phase 2 randomized controlled trial (RCT) followed by open extension.
    Summary · context
    Premenopausal women with IOP.
    Summary · context
    A total of 41 women were randomized to either teriparatide 20 mcg (n = 28) or placebo (n = 13).
    Summary · context
    After 6M, those on placebo switched to teriparatide for 24M; those on teriparatide continued for 18M.

    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 postedNCT01440803

Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women

Elizabeth Shanen = 412 Aug 2012 to 1 Feb 2019

Adult Idiopathic Generalized Osteoporosis

Trial pageClinicalTrials.govUpdated 11 Dec 2019

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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