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Study · Randomized controlled trial · n = 122 · 2018

6 results

Recombinant Human Parathyroid Hormone Effect on Health-Related Quality of Life in Adults With Chronic Hypoparathyroidism.

Vokes TJ, Mannstadt M, Levine MA, Clarke BL, Lakatos P, Chen K, Piccolo R, Krasner A, Shoback DM, Bilezikian JP

The Journal of clinical endocrinology and metabolism1 Feb 2018Cited by 54 (Europe PMC)

PMID29099947 (opens in a new tab)PMCIDPMC6458961 (opens in a new tab)DOI10.1210/jc.2017-01471 (opens in a new tab)PepBankPUB-29099947
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Summary

ContextReduced health-related quality of life (HRQoL) is common in patients with hypoparathyroidism treated conventionally with calcium and active vitamin D supplements.ObjectiveTo examine the effects of recombinant human parathyroid hormone [rhPTH(1-84)] on HRQoL as measured by the 36-Item Short-Form Health Survey (SF-36) during a multinational, randomized, placebo-controlled study.PatientsAdults (N = 122) with chronic hypoparathyroidism.Intervention(s)After an optimization period when calcium and/or active vitamin D supplements were adjusted to reach target serum calcium levels (8.0 to 9.0 mg/dL; 2.0 to 2.2 mmol/L), patients were randomly assigned to receive placebo (n = 39) or rhPTH(1-84) (n = 83) (starting dose, 50 μg/d, could be titrated up to 100 μg/d); supplement doses were adjusted to maintain target serum calcium levels.Main outcome measure(s)Change from baseline (postoptimization, at randomization) to week 24 in HRQoL as assessed by the SF-36.ResultsOverall, the between-group differences were not statistically significant. However, in the rhPTH(1-84) group, there were significant improvements in the physical component summary score (P = 0.004), and in body pain (P < 0.05), general health (P < 0.05), and vitality (P < 0.001) domains as compared with baseline values. In the placebo group, there were no significant changes for any domains. The magnitude of change between 0 and 24 weeks in SF-36 scores was negatively correlated with baseline scores, such that patients with lower HRQoL at baseline were more likely to experience improvement in response to treatment.ConclusionTreatment with rhPTH(1-84) may improve HRQoL in adults with hypoparathyroidism.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In chronic hypoparathyroidism, PTH did not significantly improve SF-36 scores versus placebo at week 24.

    In plain wordsIn chronic hypoparathyroidism, PTH did not significantly improve SF-36 scores versus placebo at week 24.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    No significant changeSF-36 health-related quality of life
    Study

    n = 122

    Comparator
    Placebo
    Outcome group
    Quality of life · Whole body
    Studied dose
    50 μg/d titrated up to 100 μg/dAs given in this study (human).

    Source sentences

    Summary
    Overall, the between-group differences were not statistically significant.
    3 context sentences
    Summary · context
    Adults (N = 122) with chronic hypoparathyroidism.
    Summary · context
    After an optimization period when calcium and/or active vitamin D supplements were adjusted to reach target serum calcium levels (8.0 to 9.0 mg/dL; 2.0 to 2.2 mmol/L), patients were randomly assigned to receive placebo (n = 39) or rhPTH(1-84) (n = 83) (starting dose, 50 μg/d, could be titrated up to 100 μg/d); supplement doses were adjusted to maintain target serum calcium levels.
    Summary · context
    Change from baseline (postoptimization, at randomization) to week 24 in HRQoL as assessed by the SF-36.
  2. 02HumanNon-randomized trialEfficacy outcome

    In chronic hypoparathyroidism, physical component summary scores improved during PTH treatment versus baseline (P = 0.004).

    In plain wordsIn chronic hypoparathyroidism, physical health scores improved during PTH treatment versus baseline.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    IncreasePhysical component summary score
    Study

    n = 83

    Comparator
    Baseline
    Outcome group
    Quality of life · Whole body
    Studied dose
    50 μg/d titrated up to 100 μg/dAs given in this study (human).

    Measurements

    P
    0.004
    physical component summary change from baseline, rhPTH(1-84) group

    Source sentences

    Summary
    However, in the rhPTH(1-84) group, there were significant improvements in the physical component summary score (P = 0.004), and in body pain (P < 0.05), general health (P < 0.05), and vitality (P < 0.001) domains as compared with baseline values.
    2 context sentences
    Summary · context
    After an optimization period when calcium and/or active vitamin D supplements were adjusted to reach target serum calcium levels (8.0 to 9.0 mg/dL; 2.0 to 2.2 mmol/L), patients were randomly assigned to receive placebo (n = 39) or rhPTH(1-84) (n = 83) (starting dose, 50 μg/d, could be titrated up to 100 μg/d); supplement doses were adjusted to maintain target serum calcium levels.
    Summary · context
    Change from baseline (postoptimization, at randomization) to week 24 in HRQoL as assessed by the SF-36.
  3. 03HumanNon-randomized trialEfficacy outcome

    In chronic hypoparathyroidism, body pain domain scores improved during PTH treatment versus baseline (P < 0.05).

    In plain wordsIn chronic hypoparathyroidism, pain scores improved during PTH treatment versus baseline.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    IncreaseBody pain domain score
    Study

    n = 83

    Comparator
    Baseline
    Outcome group
    Quality of life · Whole body
    Studied dose
    50 μg/d titrated up to 100 μg/dAs given in this study (human).

    Source sentences

    Summary
    However, in the rhPTH(1-84) group, there were significant improvements in the physical component summary score (P = 0.004), and in body pain (P < 0.05), general health (P < 0.05), and vitality (P < 0.001) domains as compared with baseline values.
    2 context sentences
    Summary · context
    After an optimization period when calcium and/or active vitamin D supplements were adjusted to reach target serum calcium levels (8.0 to 9.0 mg/dL; 2.0 to 2.2 mmol/L), patients were randomly assigned to receive placebo (n = 39) or rhPTH(1-84) (n = 83) (starting dose, 50 μg/d, could be titrated up to 100 μg/d); supplement doses were adjusted to maintain target serum calcium levels.
    Summary · context
    Change from baseline (postoptimization, at randomization) to week 24 in HRQoL as assessed by the SF-36.
  4. 04HumanNon-randomized trialEfficacy outcome

    In chronic hypoparathyroidism, general health scores improved during PTH treatment versus baseline (P < 0.05).

    In plain wordsIn chronic hypoparathyroidism, general health scores improved during PTH treatment versus baseline.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    IncreaseGeneral health domain score
    Study

    n = 83

    Comparator
    Baseline
    Outcome group
    Quality of life · Whole body
    Studied dose
    50 μg/d titrated up to 100 μg/dAs given in this study (human).

    Source sentences

    Summary
    However, in the rhPTH(1-84) group, there were significant improvements in the physical component summary score (P = 0.004), and in body pain (P < 0.05), general health (P < 0.05), and vitality (P < 0.001) domains as compared with baseline values.
    2 context sentences
    Summary · context
    After an optimization period when calcium and/or active vitamin D supplements were adjusted to reach target serum calcium levels (8.0 to 9.0 mg/dL; 2.0 to 2.2 mmol/L), patients were randomly assigned to receive placebo (n = 39) or rhPTH(1-84) (n = 83) (starting dose, 50 μg/d, could be titrated up to 100 μg/d); supplement doses were adjusted to maintain target serum calcium levels.
    Summary · context
    Change from baseline (postoptimization, at randomization) to week 24 in HRQoL as assessed by the SF-36.
  5. 05HumanNon-randomized trialEfficacy outcome

    In chronic hypoparathyroidism, vitality scores improved during PTH treatment versus baseline (P < 0.001).

    In plain wordsIn chronic hypoparathyroidism, vitality scores improved during PTH treatment versus baseline.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    IncreaseVitality domain score
    Study

    n = 83

    Comparator
    Baseline
    Outcome group
    Quality of life · Whole body
    Studied dose
    50 μg/d titrated up to 100 μg/dAs given in this study (human).

    Source sentences

    Summary
    However, in the rhPTH(1-84) group, there were significant improvements in the physical component summary score (P = 0.004), and in body pain (P < 0.05), general health (P < 0.05), and vitality (P < 0.001) domains as compared with baseline values.
    2 context sentences
    Summary · context
    After an optimization period when calcium and/or active vitamin D supplements were adjusted to reach target serum calcium levels (8.0 to 9.0 mg/dL; 2.0 to 2.2 mmol/L), patients were randomly assigned to receive placebo (n = 39) or rhPTH(1-84) (n = 83) (starting dose, 50 μg/d, could be titrated up to 100 μg/d); supplement doses were adjusted to maintain target serum calcium levels.
    Summary · context
    Change from baseline (postoptimization, at randomization) to week 24 in HRQoL as assessed by the SF-36.
  6. 06HumanObservational studyEfficacy outcome

    In hypoparathyroidism, baseline SF-36 scores were negatively correlated with changes between 0 and 24 weeks in response to treatment.

    In plain wordsIn hypoparathyroidism, lower baseline quality-of-life scores correlated with greater score improvement between weeks 0 and 24 during treatment.

    Peptide
    PTH 1-84 (parathyroid hormone)
    Outcome
    DecreaseBaseline SF-36 association with score change
    Study

    n: not reported in source

    Outcome group
    Quality of life · Whole body
    Studied dose
    50 μg/d titrated up to 100 μg/dAs given in this study (human).

    Source sentences

    Summary
    The magnitude of change between 0 and 24 weeks in SF-36 scores was negatively correlated with baseline scores, such that patients with lower HRQoL at baseline were more likely to experience improvement in response to treatment.
    2 context sentences
    Summary · context
    Adults (N = 122) with chronic hypoparathyroidism.
    Summary · context
    Change from baseline (postoptimization, at randomization) to week 24 in HRQoL as assessed by the SF-36.

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 3Results postedNCT00732615

Use of NPSP558 in the Treatment of Hypoparathyroidism

Shiren = 12418 Dec 2008 to 28 Sept 2011

Hypoparathyroidism

Trial pageClinicalTrials.govUpdated 3 Jun 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

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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