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Study · Randomized controlled trial · 2019

10 results

Abaloparatide in patients with mild or moderate renal impairment: results from the ACTIVE phase 3 trial.

Bilezikian JP, Hattersley G, Mitlak BH, Hu MY, Fitzpatrick LA, Dabrowski C, Miller PD, Papapoulos SE

Current medical research and opinion11 Sept 2019Cited by 37 (Europe PMC)

PMID31418585 (opens in a new tab)DOI10.1080/03007995.2019.1656955 (opens in a new tab)PepBankPUB-31418585
Publisher pagePubMedAsk about this study
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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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study10

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In women with eGFR <60 mL/min, hypercalcemia occurred less frequently with abaloparatide than teriparatide.

    In plain wordsIn women with poorer kidney function, high blood calcium occurred less often with abaloparatide than teriparatide.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    DecreaseHypercalcemia with eGFR below 60
    Study

    n: not reported in source

    Comparator
    Teriparatide
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    80 µg daily · subcutaneous · 18 monthsAs given in this study (human).

    Measurements

    Hypercalcemia
    3.6%
    abaloparatide; eGFR <60 mL/min
    Hypercalcemia
    10.9%
    teriparatide; eGFR <60 mL/min

    Source sentences

    Summary
    Hypercalcemia measured by albumin-adjusted serum calcium occurred significantly less frequently with abaloparatide than teriparatide in patients with eGFR p = .008) and in the overall ACTIVE safety population (3.4% versus 6.4%; p = .006).
    1 context sentence
    Summary · context
    ACTIVE was a phase 3, 18-month, randomized, double-blind, active-comparator, placebo-controlled study of postmenopausal women with osteoporosis who received subcutaneous abaloparatide 80 µg, placebo, or open-label teriparatide 20 µg daily.
  2. 02HumanRandomized controlled trialSafety outcome

    In the overall ACTIVE safety population, hypercalcemia occurred less frequently with abaloparatide than teriparatide.

    In plain wordsIn the overall safety population, high blood calcium occurred less often with abaloparatide than teriparatide.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    DecreaseHypercalcemia in overall safety population
    Study

    n: not reported in source

    Comparator
    Teriparatide
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    80 µg daily · subcutaneous · 18 monthsAs given in this study (human).

    Measurements

    Hypercalcemia
    3.4%
    abaloparatide overall
    Hypercalcemia
    6.4%
    teriparatide overall

    Source sentences

    Summary
    Hypercalcemia measured by albumin-adjusted serum calcium occurred significantly less frequently with abaloparatide than teriparatide in patients with eGFR p = .008) and in the overall ACTIVE safety population (3.4% versus 6.4%; p = .006).
    1 context sentence
    Summary · context
    ACTIVE was a phase 3, 18-month, randomized, double-blind, active-comparator, placebo-controlled study of postmenopausal women with osteoporosis who received subcutaneous abaloparatide 80 µg, placebo, or open-label teriparatide 20 µg daily.

Studies that did not test the peptide alone8

In this study, Abaloparatide (Tymlos) 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 Abaloparatide (Tymlos).

  1. 03HumanNot a test of Abaloparatide (Tymlos) aloneObservational studySafety outcome

    In scanned ACTIVE patients, computed tomography showed no evidence of increased renal calcification.

    In plain wordsIn patients who had CT scans, kidney calcification showed no sign of increase.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changeRenal calcification
    Study

    n = 376

    Outcome group
    Kidney function · Kidney and urinary

    Source sentences

    Summary
    Computed tomography scans in 376 patients revealed no evidence of increased renal calcification.
    1 context sentence
    Summary · context
    ACTIVE was a phase 3, 18-month, randomized, double-blind, active-comparator, placebo-controlled study of postmenopausal women with osteoporosis who received subcutaneous abaloparatide 80 µg, placebo, or open-label teriparatide 20 µg daily.

    In this study, Abaloparatide (Tymlos) 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 Abaloparatide (Tymlos).

  2. 04HumanNot a test of Abaloparatide (Tymlos) aloneObservational studyEfficacy outcome

    In postmenopausal women in ACTIVE, the pooled active-treatment arms (abaloparatide and teriparatide) showed no meaningful BMD differences among renal-function subgroups.

    In plain wordsIn women in the ACTIVE trial, bone density in the abaloparatide and teriparatide arms was similar across kidney-function groups.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changeBMD by renal function
    Study

    n: not reported in source

    Comparator
    Other renal-function subgroups
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    Among renal-function subgroups, there were no meaningful changes in bone mineral density, fracture risk reduction, or overall incidence of treatment-emergent adverse events in the active-treatment arms.
    1 context sentence
    Summary · context
    ACTIVE was a phase 3, 18-month, randomized, double-blind, active-comparator, placebo-controlled study of postmenopausal women with osteoporosis who received subcutaneous abaloparatide 80 µg, placebo, or open-label teriparatide 20 µg daily.

    In this study, Abaloparatide (Tymlos) 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 Abaloparatide (Tymlos).

  3. 05HumanNot a test of Abaloparatide (Tymlos) aloneObservational studyEfficacy outcome

    In postmenopausal women in ACTIVE, the pooled active-treatment arms (abaloparatide and teriparatide) showed no meaningful differences in fracture risk reduction among renal-function subgroups.

    In plain wordsIn women in the ACTIVE trial, fracture risk reduction in the abaloparatide and teriparatide arms was similar across kidney-function groups.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changeFracture risk reduction by renal function
    Study

    n: not reported in source

    Comparator
    Other renal-function subgroups
    Outcome group
    Bone and joint · Musculoskeletal

    Source sentences

    Summary
    Among renal-function subgroups, there were no meaningful changes in bone mineral density, fracture risk reduction, or overall incidence of treatment-emergent adverse events in the active-treatment arms.
    1 context sentence
    Summary · context
    ACTIVE was a phase 3, 18-month, randomized, double-blind, active-comparator, placebo-controlled study of postmenopausal women with osteoporosis who received subcutaneous abaloparatide 80 µg, placebo, or open-label teriparatide 20 µg daily.

    In this study, Abaloparatide (Tymlos) 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 Abaloparatide (Tymlos).

  4. 06HumanNot a test of Abaloparatide (Tymlos) aloneObservational studySafety outcome

    In postmenopausal women in ACTIVE, overall treatment-emergent adverse event incidence in the pooled active-treatment arms (abaloparatide and teriparatide) showed no meaningful renal-subgroup differences.

    In plain wordsIn women in the ACTIVE trial, overall adverse event rates in the abaloparatide and teriparatide arms were similar across kidney-function groups.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    No significant changeTreatment-emergent adverse events by renal function
    Study

    n: not reported in source

    Comparator
    Other renal-function subgroups
    Outcome group
    Adverse events · Whole body

    Source sentences

    Summary
    Among renal-function subgroups, there were no meaningful changes in bone mineral density, fracture risk reduction, or overall incidence of treatment-emergent adverse events in the active-treatment arms.
    1 context sentence
    Summary · context
    ACTIVE was a phase 3, 18-month, randomized, double-blind, active-comparator, placebo-controlled study of postmenopausal women with osteoporosis who received subcutaneous abaloparatide 80 µg, placebo, or open-label teriparatide 20 µg daily.

    In this study, Abaloparatide (Tymlos) 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 Abaloparatide (Tymlos).

  5. 07HumanNot a test of Abaloparatide (Tymlos) aloneObservational studySafety outcome

    In women in the ACTIVE trial (arms not specified), anemia tended to be more frequent with increasing renal impairment.

    In plain wordsIn women in the ACTIVE trial, anemia tended to occur more often with worse kidney function. The source does not say which arms.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseAnemia by renal impairment
    Study

    n: not reported in source

    Comparator
    Other renal-function subgroups
    Outcome group
    Adverse events · Whole body

    Source sentences

    Summary
    Anemia, nausea, hypercalcemia, and upper-respiratory-tract infection tended to be more frequent with increasing renal impairment.
    1 context sentence
    Summary · context
    ACTIVE was a phase 3, 18-month, randomized, double-blind, active-comparator, placebo-controlled study of postmenopausal women with osteoporosis who received subcutaneous abaloparatide 80 µg, placebo, or open-label teriparatide 20 µg daily.

    In this study, Abaloparatide (Tymlos) 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 Abaloparatide (Tymlos).

  6. 08HumanNot a test of Abaloparatide (Tymlos) aloneObservational studySafety outcome

    In women in the ACTIVE trial (arms not specified), nausea tended to be more frequent with increasing renal impairment.

    In plain wordsIn women in the ACTIVE trial, nausea tended to occur more often with worse kidney function. The source does not say which arms.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseNausea by renal impairment
    Study

    n: not reported in source

    Comparator
    Other renal-function subgroups
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal

    Source sentences

    Summary
    Anemia, nausea, hypercalcemia, and upper-respiratory-tract infection tended to be more frequent with increasing renal impairment.
    1 context sentence
    Summary · context
    ACTIVE was a phase 3, 18-month, randomized, double-blind, active-comparator, placebo-controlled study of postmenopausal women with osteoporosis who received subcutaneous abaloparatide 80 µg, placebo, or open-label teriparatide 20 µg daily.

    In this study, Abaloparatide (Tymlos) 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 Abaloparatide (Tymlos).

  7. 09HumanNot a test of Abaloparatide (Tymlos) aloneObservational studySafety outcome

    In women in the ACTIVE trial (arms not specified), hypercalcemia tended to be more frequent with increasing renal impairment.

    In plain wordsIn women in the ACTIVE trial, high blood calcium tended to occur more often with worse kidney function. The source does not say which arms.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseHypercalcemia by renal impairment
    Study

    n: not reported in source

    Comparator
    Other renal-function subgroups
    Outcome group
    Adverse events · Endocrine and hormones

    Source sentences

    Summary
    Anemia, nausea, hypercalcemia, and upper-respiratory-tract infection tended to be more frequent with increasing renal impairment.
    1 context sentence
    Summary · context
    ACTIVE was a phase 3, 18-month, randomized, double-blind, active-comparator, placebo-controlled study of postmenopausal women with osteoporosis who received subcutaneous abaloparatide 80 µg, placebo, or open-label teriparatide 20 µg daily.

    In this study, Abaloparatide (Tymlos) 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 Abaloparatide (Tymlos).

  8. 10HumanNot a test of Abaloparatide (Tymlos) aloneObservational studySafety outcome

    In women in the ACTIVE trial (arms not specified), upper respiratory tract infection tended to be more frequent with increasing renal impairment.

    In plain wordsIn women in the ACTIVE trial, upper respiratory infections tended to occur more often with worse kidney function. The source does not say which arms.

    Peptide
    Abaloparatide (Tymlos)
    Outcome
    IncreaseUpper respiratory tract infection by renal impairment
    Study

    n: not reported in source

    Comparator
    Other renal-function subgroups
    Outcome group
    Adverse events · Respiratory

    Source sentences

    Summary
    Anemia, nausea, hypercalcemia, and upper-respiratory-tract infection tended to be more frequent with increasing renal impairment.
    1 context sentence
    Summary · context
    ACTIVE was a phase 3, 18-month, randomized, double-blind, active-comparator, placebo-controlled study of postmenopausal women with osteoporosis who received subcutaneous abaloparatide 80 µg, placebo, or open-label teriparatide 20 µg daily.

    In this study, Abaloparatide (Tymlos) 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 Abaloparatide (Tymlos).

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, 02:25 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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