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Study · Randomized controlled trial · n = 573 · 2022

8 results

Efficacy of generic teriparatide and alendronate in Chinese postmenopausal women with osteoporosis: a prospective study.

Li M, Zhang Z, Xue Q, Li Q, Jin X, Dong J, Cheng Q, You L, Lin H, Tang H, Shen L, Gao X and 9 more

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Hu J, Chao A, Li P, Shi R, Zheng S, Zhang Y, Xiong X, Yu W, Xia W

Archives of osteoporosis28 Jul 2022Cited by 18 (Europe PMC)

PMID35900607 (opens in a new tab)PMCIDPMC9334369 (opens in a new tab)DOI10.1007/s11657-022-01131-8 (opens in a new tab)PepBankPUB-35900607
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Summary

The efficacy of generic teriparatide in improving BMD at lumbar spine in patients with osteoporosis was similar to that of alendronate. It provided a new choice for osteoporosis treatment in Chinese population.IntroductionTo determine whether the efficacy of generic teriparatide is noninferior to alendronate for Chinese postmenopausal women with osteoporosis.MethodsEligible patients were randomly assigned (2:1) in a 48-week, open-label design to receive 20 µg sc daily teriparatide or 70 mg oral weekly alendronate. Primary outcome was percentage change in BMD at the lumbar spine from baseline to 48 weeks and was assessed for non-inferiority. The same outcome was further assessed for superiority as a secondary endpoint.ResultsThree hundred ninety-one and 196 participants were randomly assigned to the teriparatide or alendronate group, of whom 379 and 194 receiving at least one dose of teriparatide and alendronate treatment were eligible for the efficacy analysis. Teriparatide was non-inferior to alendronate for BMD change at lumbar spine (treatment difference: 0.7%, 95% CI: - 0.3 to 1.7%), which excluded the predefined non-inferiority margin of - 1.5%. However, teriparatide was not statistically superior to alendronate in improving BMD at lumbar spine (P = 0.169). At 48 weeks, changes in BMD at total hip were - 1.0% and 2.2% in teriparatide and alendronate group, respectively (P < 0.001). The incidence of new fracture showed no statistical difference between groups (P = 0.128). Serum P1NP and β-CTX levels significantly increased in the teriparatide group and markedly decreased in alendronate group (all P < 0.001 vs baseline). The adverse events (AEs) and serious AEs were more common in the teriparatide group than in the alendronate group, which were mainly teriparatide-related hypercalcemia, elevated alkaline phosphatase or parathyroid hormone, dizziness, and arthralgia.ConclusionsTeriparatide was not inferior to alendronate in increasing BMD at lumbar spine in Chinese postmenopausal women, and they achieved these effects through different mechanisms.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Chinese postmenopausal women with osteoporosis, teriparatide was non-inferior to alendronate for lumbar spine BMD change.

    In plain wordsIn women with osteoporosis, teriparatide was non-inferior to alendronate for spine bone density change.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    Not applicableLumbar spine BMD non-inferiority
    Study

    n = 573

    Comparator
    alendronate
    Analysis
    Primary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg daily · subcutaneous · 48 weeksAs given in this study (human).

    Measurements

    treatment difference
    0.7%
    teriparatide versus alendronate
    95% CI of treatment difference
    −0.3 to 1.7%
    teriparatide versus alendronate

    Source sentences

    Summary
    Teriparatide was non-inferior to alendronate for BMD change at lumbar spine (treatment difference: 0.7%, 95% CI: - 0.3 to 1.7%), which excluded the predefined non-inferiority margin of - 1.5%.
    1 context sentence
    Summary · context
    Eligible patients were randomly assigned (2:1) in a 48-week, open-label design to receive 20 µg sc daily teriparatide or 70 mg oral weekly alendronate.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Chinese postmenopausal women with osteoporosis, teriparatide did not significantly outperform alendronate for lumbar spine BMD improvement.

    In plain wordsIn women with osteoporosis, teriparatide did not improve spine bone density significantly more than alendronate.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeLumbar spine BMD superiority
    Study

    n = 573

    Comparator
    alendronate
    Analysis
    Secondary
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg daily · subcutaneous · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    However, teriparatide was not statistically superior to alendronate in improving BMD at lumbar spine (P = 0.169).
    1 context sentence
    Summary · context
    Eligible patients were randomly assigned (2:1) in a 48-week, open-label design to receive 20 µg sc daily teriparatide or 70 mg oral weekly alendronate.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In women with osteoporosis, total hip BMD change was lower with teriparatide than alendronate at 48 weeks.

    In plain wordsIn women with osteoporosis, hip bone density change was lower with teriparatide than alendronate.

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

    n = 573

    Comparator
    alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg daily · subcutaneous · 48 weeksAs given in this study (human).

    Measurements

    BMD change
    −1%
    teriparatide
    BMD change
    2.2%
    alendronate

    Source sentences

    Summary
    At 48 weeks, changes in BMD at total hip were - 1.0% and 2.2% in teriparatide and alendronate group, respectively (P < 0.001).
    1 context sentence
    Summary · context
    Eligible patients were randomly assigned (2:1) in a 48-week, open-label design to receive 20 µg sc daily teriparatide or 70 mg oral weekly alendronate.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In women with osteoporosis, new fracture incidence did not differ significantly between teriparatide and alendronate.

    In plain wordsIn women with osteoporosis, new fractures did not differ significantly between teriparatide and alendronate.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeNew fractures
    Study

    n = 573

    Comparator
    alendronate
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg daily · subcutaneous · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    The incidence of new fracture showed no statistical difference between groups (P = 0.128).
    1 context sentence
    Summary · context
    Eligible patients were randomly assigned (2:1) in a 48-week, open-label design to receive 20 µg sc daily teriparatide or 70 mg oral weekly alendronate.
  5. 05HumanRandomized controlled trialActivity measurement

    In women with osteoporosis, serum P1NP increased significantly from baseline with teriparatide.

    In plain wordsIn women with osteoporosis, teriparatide increased serum P1NP compared with baseline.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseSerum P1NP
    Study

    n: not reported in source

    Comparator
    baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg daily · subcutaneous · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    Serum P1NP and β-CTX levels significantly increased in the teriparatide group and markedly decreased in alendronate group (all P < 0.001 vs baseline).
    1 context sentence
    Summary · context
    Eligible patients were randomly assigned (2:1) in a 48-week, open-label design to receive 20 µg sc daily teriparatide or 70 mg oral weekly alendronate.
  6. 06HumanRandomized controlled trialActivity measurement

    In women with osteoporosis, serum β-CTX increased significantly from baseline with teriparatide.

    In plain wordsIn women with osteoporosis, teriparatide increased serum β-CTX compared with baseline.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseSerum β-CTX
    Study

    n: not reported in source

    Comparator
    baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    20 µg daily · subcutaneous · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    Serum P1NP and β-CTX levels significantly increased in the teriparatide group and markedly decreased in alendronate group (all P < 0.001 vs baseline).
    1 context sentence
    Summary · context
    Eligible patients were randomly assigned (2:1) in a 48-week, open-label design to receive 20 µg sc daily teriparatide or 70 mg oral weekly alendronate.
  7. 07HumanRandomized controlled trialSafety outcome

    In women with osteoporosis, adverse events were more common with teriparatide than alendronate.

    In plain wordsIn women with osteoporosis, adverse events were more common with teriparatide than alendronate.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseAdverse events
    Study

    n: not reported in source

    Comparator
    alendronate
    Outcome group
    Adverse events · Whole body
    Studied dose
    20 µg daily · subcutaneous · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    The adverse events (AEs) and serious AEs were more common in the teriparatide group than in the alendronate group, which were mainly teriparatide-related hypercalcemia, elevated alkaline phosphatase or parathyroid hormone, dizziness, and arthralgia.
    1 context sentence
    Summary · context
    Eligible patients were randomly assigned (2:1) in a 48-week, open-label design to receive 20 µg sc daily teriparatide or 70 mg oral weekly alendronate.
  8. 08HumanRandomized controlled trialSafety outcome

    In women with osteoporosis, serious adverse events were more common with teriparatide than alendronate.

    In plain wordsIn women with osteoporosis, serious adverse events were more common with teriparatide than alendronate.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseSerious adverse events
    Study

    n: not reported in source

    Comparator
    alendronate
    Outcome group
    Adverse events · Whole body
    Studied dose
    20 µg daily · subcutaneous · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    The adverse events (AEs) and serious AEs were more common in the teriparatide group than in the alendronate group, which were mainly teriparatide-related hypercalcemia, elevated alkaline phosphatase or parathyroid hormone, dizziness, and arthralgia.
    1 context sentence
    Summary · context
    Eligible patients were randomly assigned (2:1) in a 48-week, open-label design to receive 20 µg sc daily teriparatide or 70 mg oral weekly alendronate.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

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

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