Extended Treatment With Recombinant Human Parathyroid Hormone (1-84) in Adult Patients With Chronic Hypoparathyroidism.

Rubin MR, Cusano N, Yin S, Tokareva E, Ayodele O, Finkelman RD

Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists10 Dec 2023Cited by 8 (Europe PMC)

PMID38086524DOI10.1016/j.eprac.2023.12.001PepBankPUB-38086524

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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 study11

11 results from studies that gave the peptide. 11 results from people.

01HumanNon-randomized trialEfficacy outcome
In adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), mean albumin-adjusted serum calcium was within the target range at treatment end.
In plain wordsIn adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), mean serum calcium was within the target range at treatment end.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableAlbumin-adjusted serum calcium
Study
n = 39
Analysis
Primary
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
Dose not stated · subcutaneous · 3 yearsAs given in this study (human).
Source sentences
Summary
Mean albumin-adjusted serum calcium concentrations were within the target range, and mean serum phosphate, serum calcium-phosphate product, and 24-hour urinary calcium excretion levels were within reference ranges at end of treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 4, single-center, open-label, single-arm, 3-year extension (NCT02910466) of the phase 3 Hypo Extended (HEXT) study (NCT01199614).
Summary · context
Patients self-administered rhPTH(1-84) once daily by subcutaneous injection, with doses individualized based on clinical parameters.
Summary · context
All patients (n = 39) had been exposed to rhPTH(1-84) (mean exposure [SD] 8.5 [3.5] years) before the start of the study, resulting in a mean exposure of 10.8 years including the present study.
Report a problemFND-3808652401
02HumanNon-randomized trialEfficacy outcome
In adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), mean serum phosphate was within the reference range at treatment end.
In plain wordsIn adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), mean serum phosphate was within the reference range at treatment end.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableSerum phosphate
Study
n = 39
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
Dose not stated · subcutaneous · 3 yearsAs given in this study (human).
Source sentences
Summary
Mean albumin-adjusted serum calcium concentrations were within the target range, and mean serum phosphate, serum calcium-phosphate product, and 24-hour urinary calcium excretion levels were within reference ranges at end of treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 4, single-center, open-label, single-arm, 3-year extension (NCT02910466) of the phase 3 Hypo Extended (HEXT) study (NCT01199614).
Summary · context
Patients self-administered rhPTH(1-84) once daily by subcutaneous injection, with doses individualized based on clinical parameters.
Summary · context
All patients (n = 39) had been exposed to rhPTH(1-84) (mean exposure [SD] 8.5 [3.5] years) before the start of the study, resulting in a mean exposure of 10.8 years including the present study.
Report a problemFND-3808652402
03HumanNon-randomized trialEfficacy outcome
In adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), mean serum calcium-phosphate product was within the reference range at treatment end.
In plain wordsIn adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), mean calcium-phosphate product was within the reference range at treatment end.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableSerum calcium-phosphate product
Study
n = 39
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
Dose not stated · subcutaneous · 3 yearsAs given in this study (human).
Source sentences
Summary
Mean albumin-adjusted serum calcium concentrations were within the target range, and mean serum phosphate, serum calcium-phosphate product, and 24-hour urinary calcium excretion levels were within reference ranges at end of treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 4, single-center, open-label, single-arm, 3-year extension (NCT02910466) of the phase 3 Hypo Extended (HEXT) study (NCT01199614).
Summary · context
Patients self-administered rhPTH(1-84) once daily by subcutaneous injection, with doses individualized based on clinical parameters.
Summary · context
All patients (n = 39) had been exposed to rhPTH(1-84) (mean exposure [SD] 8.5 [3.5] years) before the start of the study, resulting in a mean exposure of 10.8 years including the present study.
Report a problemFND-3808652403
04HumanNon-randomized trialEfficacy outcome
In adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), mean 24-hour urinary calcium excretion was within the reference range at treatment end.
In plain wordsIn adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), mean urinary calcium excretion was within the reference range at treatment end.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableUrinary calcium
Study
n = 39
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated · subcutaneous · 3 yearsAs given in this study (human).
Source sentences
Summary
Mean albumin-adjusted serum calcium concentrations were within the target range, and mean serum phosphate, serum calcium-phosphate product, and 24-hour urinary calcium excretion levels were within reference ranges at end of treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 4, single-center, open-label, single-arm, 3-year extension (NCT02910466) of the phase 3 Hypo Extended (HEXT) study (NCT01199614).
Summary · context
Patients self-administered rhPTH(1-84) once daily by subcutaneous injection, with doses individualized based on clinical parameters.
Summary · context
All patients (n = 39) had been exposed to rhPTH(1-84) (mean exposure [SD] 8.5 [3.5] years) before the start of the study, resulting in a mean exposure of 10.8 years including the present study.
Report a problemFND-3808652404
05HumanNon-randomized trialEfficacy outcome
In adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), mean supplemental calcium doses were maintained throughout the study.
In plain wordsIn adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), mean calcium supplement doses were maintained throughout the study.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableSupplemental calcium dose
Study
n = 39
Outcome group
Supplement Requirements · Endocrine and hormones
Studied dose
Dose not stated · subcutaneous · 3 yearsAs given in this study (human).
Source sentences
Summary
Mean doses of supplemental calcium and active vitamin D were maintained throughout the study.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 4, single-center, open-label, single-arm, 3-year extension (NCT02910466) of the phase 3 Hypo Extended (HEXT) study (NCT01199614).
Summary · context
Patients self-administered rhPTH(1-84) once daily by subcutaneous injection, with doses individualized based on clinical parameters.
Summary · context
All patients (n = 39) had been exposed to rhPTH(1-84) (mean exposure [SD] 8.5 [3.5] years) before the start of the study, resulting in a mean exposure of 10.8 years including the present study.
Report a problemFND-3808652405
06HumanNon-randomized trialEfficacy outcome
In adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), mean active vitamin D doses were maintained throughout the study.
In plain wordsIn adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), mean active vitamin D doses were maintained throughout the study.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableActive vitamin D dose
Study
n = 39
Outcome group
Supplement Requirements · Endocrine and hormones
Studied dose
Dose not stated · subcutaneous · 3 yearsAs given in this study (human).
Source sentences
Summary
Mean doses of supplemental calcium and active vitamin D were maintained throughout the study.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 4, single-center, open-label, single-arm, 3-year extension (NCT02910466) of the phase 3 Hypo Extended (HEXT) study (NCT01199614).
Summary · context
Patients self-administered rhPTH(1-84) once daily by subcutaneous injection, with doses individualized based on clinical parameters.
Summary · context
All patients (n = 39) had been exposed to rhPTH(1-84) (mean exposure [SD] 8.5 [3.5] years) before the start of the study, resulting in a mean exposure of 10.8 years including the present study.
Report a problemFND-3808652406
07HumanNon-randomized trialEfficacy outcome
In adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), bone turnover marker levels were maintained from baseline to treatment end.
In plain wordsIn adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), bone turnover marker levels were maintained from baseline to treatment end.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableBone turnover markers
Study
n = 39
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneous · 3 yearsAs given in this study (human).
Source sentences
Summary
Bone turnover marker levels were maintained from baseline to end of treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 4, single-center, open-label, single-arm, 3-year extension (NCT02910466) of the phase 3 Hypo Extended (HEXT) study (NCT01199614).
Summary · context
Patients self-administered rhPTH(1-84) once daily by subcutaneous injection, with doses individualized based on clinical parameters.
Summary · context
All patients (n = 39) had been exposed to rhPTH(1-84) (mean exposure [SD] 8.5 [3.5] years) before the start of the study, resulting in a mean exposure of 10.8 years including the present study.
Report a problemFND-3808652407
08HumanNon-randomized trialEfficacy outcome
In adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), no clinically relevant bone mineral density changes were observed.
In plain wordsIn adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), bone mineral density showed no clinically relevant changes.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableBone mineral density
Study
n = 39
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneous · 3 yearsAs given in this study (human).
Source sentences
Summary
No clinically relevant changes in bone mineral density were observed.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 4, single-center, open-label, single-arm, 3-year extension (NCT02910466) of the phase 3 Hypo Extended (HEXT) study (NCT01199614).
Summary · context
Patients self-administered rhPTH(1-84) once daily by subcutaneous injection, with doses individualized based on clinical parameters.
Summary · context
All patients (n = 39) had been exposed to rhPTH(1-84) (mean exposure [SD] 8.5 [3.5] years) before the start of the study, resulting in a mean exposure of 10.8 years including the present study.
Report a problemFND-3808652408
09HumanNon-randomized trialEfficacy outcome
In adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), health-related quality-of-life scores were generally maintained throughout the study.
In plain wordsIn adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), quality-of-life scores were generally maintained throughout the study.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableHealth-related quality of life
Study
n = 39
Outcome group
Quality of life · Endocrine and hormones
Studied dose
Dose not stated · subcutaneous · 3 yearsAs given in this study (human).
Source sentences
Summary
Patient-reported health-related quality-of-life scores were generally maintained throughout the study.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 4, single-center, open-label, single-arm, 3-year extension (NCT02910466) of the phase 3 Hypo Extended (HEXT) study (NCT01199614).
Summary · context
Patients self-administered rhPTH(1-84) once daily by subcutaneous injection, with doses individualized based on clinical parameters.
Summary · context
All patients (n = 39) had been exposed to rhPTH(1-84) (mean exposure [SD] 8.5 [3.5] years) before the start of the study, resulting in a mean exposure of 10.8 years including the present study.
Report a problemFND-3808652409
10HumanNon-randomized trialSafety outcome
In adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), four adverse events were considered treatment related.
In plain wordsIn adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), four adverse events were considered treatment related.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableTreatment-related adverse events
Study
n = 39
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneous · 3 yearsAs given in this study (human).
Measurements
Treatment-related adverse events
4 events
extended rhPTH(1-84)
Source sentences
Summary
Four adverse events were considered treatment related and no new safety signals were identified.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 4, single-center, open-label, single-arm, 3-year extension (NCT02910466) of the phase 3 Hypo Extended (HEXT) study (NCT01199614).
Summary · context
Patients self-administered rhPTH(1-84) once daily by subcutaneous injection, with doses individualized based on clinical parameters.
Summary · context
All patients (n = 39) had been exposed to rhPTH(1-84) (mean exposure [SD] 8.5 [3.5] years) before the start of the study, resulting in a mean exposure of 10.8 years including the present study.
Report a problemFND-3808652410
11HumanNon-randomized trialSafety outcome
In adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), no new safety signals were identified.
In plain wordsIn adults with chronic hypoparathyroidism receiving extended rhPTH(1-84), no new safety signals were identified.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Not applicableNew safety signals
Study
n = 39
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneous · 3 yearsAs given in this study (human).
Source sentences
Summary
Four adverse events were considered treatment related and no new safety signals were identified.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 4, single-center, open-label, single-arm, 3-year extension (NCT02910466) of the phase 3 Hypo Extended (HEXT) study (NCT01199614).
Summary · context
Patients self-administered rhPTH(1-84) once daily by subcutaneous injection, with doses individualized based on clinical parameters.
Summary · context
All patients (n = 39) had been exposed to rhPTH(1-84) (mean exposure [SD] 8.5 [3.5] years) before the start of the study, resulting in a mean exposure of 10.8 years including the present study.
Report a problemFND-3808652411

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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

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