Transitory Activation and Improved Transition from Erosion to Formation within Intracortical Bone Remodeling in Hypoparathyroid Patients Treated with rhPTH(1-84).

van Dijk Christiansen P, Sikjær T, Andreasen CM, Thomsen JS, Brüel A, Hauge EM, Delaisse JM, Rejnmark L, Andersen TL

JBMR plus17 Nov 2023Cited by 4 (Europe PMC)

PMID38130746PMCIDPMC10731115DOI10.1002/jbm4.10829PepBankPUB-38130746

Summary

In hypoparathyroidism, lack of parathyroid hormone (PTH) leads to low calcium levels and decreased bone remodeling. Treatment with recombinant human PTH (rhPTH) may normalize bone turnover. This study aimed to investigate whether rhPTH(1-84) continued to activate intracortical bone remodeling after 30 months and promoted the transition from erosion to formation and whether this effect was transitory when rhPTH(1-84) was discontinued. Cortical histomorphometry was performed on 60 bone biopsies from patients (aged 31 to 78 years) with chronic hypoparathyroidism randomized to either 100 μg rhPTH(1-84) a day (n = 21) (PTH) or similar placebo (n = 21) (PLB) for 6 months as add-on to conventional therapy. This was followed by an open-label extension, where patients extended their rhPTH(1-84) (PTH) (n = 5), continued conventional treatment (CON) (n = 5), or withdrew from rhPTH(1-84) and resumed conventional therapy (PTHw) for an additional 24 months (n = 8). Bone biopsies were collected at months 6 (n = 42) and 30 (n = 18). After 6 and 30 months, the overall cortical microarchitecture (cortical porosity, thickness, pore density, and mean pore diameter) in the PTH group did not differ from that of the PLB/CON and PTHw groups. Still, the PTH group had a significantly and persistently higher percentage of pores undergoing remodeling than the PLB/CON groups. A significantly higher percentage of these pores was undergoing bone formation in the PTH compared with the PLB/CON groups, whereas the percentage of pores with erosion only was not different. This resulted in a shift in the ratio between formative and eroded pores, reflecting a faster transition from erosion to formation in the PTH-treated patients. In the rhPTH(1-84) withdrawal group PTHw, the latter effects of PTH were completely reversed in comparison to those of the PLB/CON groups. In conclusion, rhPTH(1-84) replacement therapy in hypoparathyroidism patients promotes intracortical remodeling and its transition from erosion to formation without affecting the overall cortical microstructure. The effect persists for at least 30 months and is reversible when treatment is withdrawn. © 2023 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study12

12 results from studies that gave the peptide. 12 results from people.

01HumanRandomized controlled trialEfficacy outcome
In hypoparathyroidism, PTH cortical microarchitecture did not differ from placebo after 6 months.
In plain wordsIn hypoparathyroidism, PTH cortical microarchitecture did not differ from placebo after 6 months.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
No significant changeCortical microarchitecture at six months
Study
n = 42
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 μg a day · 6 monthsAs given in this study (human).
Source sentences
Summary
After 6 and 30 months, the overall cortical microarchitecture (cortical porosity, thickness, pore density, and mean pore diameter) in the PTH group did not differ from that of the PLB/CON and PTHw groups.
2 context sentences(design, population, supporting numbers)
Summary · context
Cortical histomorphometry was performed on 60 bone biopsies from patients (aged 31 to 78 years) with chronic hypoparathyroidism randomized to either 100 μg rhPTH(1-84) a day (n = 21) (PTH)
Summary · context
This was followed by an open-label extension, where patients extended their rhPTH(1-84) (PTH) (n = 5), continued conventional treatment (CON) (n = 5), or withdrew from rhPTH(1-84) and resumed conventional therapy (PTHw) for an additional 24 months (n = 8).
Show in the study text Report a problemFND-3813074601
02HumanRandomized controlled trialEfficacy outcome
In hypoparathyroidism, PTH increased the percentage of remodeling pores versus placebo.
In plain wordsIn hypoparathyroidism, PTH increased the percentage of remodeling pores versus placebo.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreasePores undergoing remodeling at six months
Study
n = 42
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 μg a day · 6 monthsAs given in this study (human).
Source sentences
Summary
Still, the PTH group had a significantly and persistently higher percentage of pores undergoing remodeling than the PLB/CON groups.
2 context sentences(design, population, supporting numbers)
Summary · context
Cortical histomorphometry was performed on 60 bone biopsies from patients (aged 31 to 78 years) with chronic hypoparathyroidism randomized to either 100 μg rhPTH(1-84) a day (n = 21) (PTH)
Summary · context
This was followed by an open-label extension, where patients extended their rhPTH(1-84) (PTH) (n = 5), continued conventional treatment (CON) (n = 5), or withdrew from rhPTH(1-84) and resumed conventional therapy (PTHw) for an additional 24 months (n = 8).
Show in the study text Report a problemFND-3813074604
03HumanRandomized controlled trialEfficacy outcome
In hypoparathyroidism, PTH increased the percentage of formative pores versus placebo.
In plain wordsIn hypoparathyroidism, PTH increased the percentage of formative pores versus placebo.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreasePores undergoing bone formation at six months
Study
n = 42
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 μg a day · 6 monthsAs given in this study (human).
Source sentences
Summary
A significantly higher percentage of these pores was undergoing bone formation in the PTH compared with the PLB/CON groups, whereas the percentage of pores with erosion only was not different.
2 context sentences(design, population, supporting numbers)
Summary · context
Cortical histomorphometry was performed on 60 bone biopsies from patients (aged 31 to 78 years) with chronic hypoparathyroidism randomized to either 100 μg rhPTH(1-84) a day (n = 21) (PTH)
Summary · context
This was followed by an open-label extension, where patients extended their rhPTH(1-84) (PTH) (n = 5), continued conventional treatment (CON) (n = 5), or withdrew from rhPTH(1-84) and resumed conventional therapy (PTHw) for an additional 24 months (n = 8).
Show in the study text Report a problemFND-3813074606
04HumanRandomized controlled trialEfficacy outcome
In hypoparathyroidism, PTH did not change the percentage of erosion-only pores versus placebo.
In plain wordsIn hypoparathyroidism, PTH did not change the percentage of erosion-only pores versus placebo.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
No significant changePores with erosion only at six months
Study
n = 42
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 μg a day · 6 monthsAs given in this study (human).
Source sentences
Summary
A significantly higher percentage of these pores was undergoing bone formation in the PTH compared with the PLB/CON groups, whereas the percentage of pores with erosion only was not different.
2 context sentences(design, population, supporting numbers)
Summary · context
Cortical histomorphometry was performed on 60 bone biopsies from patients (aged 31 to 78 years) with chronic hypoparathyroidism randomized to either 100 μg rhPTH(1-84) a day (n = 21) (PTH)
Summary · context
This was followed by an open-label extension, where patients extended their rhPTH(1-84) (PTH) (n = 5), continued conventional treatment (CON) (n = 5), or withdrew from rhPTH(1-84) and resumed conventional therapy (PTHw) for an additional 24 months (n = 8).
Show in the study text Report a problemFND-3813074608
05HumanRandomized controlled trialEfficacy outcome
In hypoparathyroidism, PTH shifted the formative-to-eroded pore ratio toward formation versus placebo after 6 months.
In plain wordsIn hypoparathyroidism, PTH shifted the balance of bone pores toward formation versus placebo after 6 months.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseFormative-to-eroded pore ratio at 6 months
Study
n = 42
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 μg a day · 6 monthsAs given in this study (human).
Source sentences
Summary
This resulted in a shift in the ratio between formative and eroded pores, reflecting a faster transition from erosion to formation in the PTH-treated patients.
3 context sentences(design, population, supporting numbers)
Summary · context
A significantly higher percentage of these pores was undergoing bone formation in the PTH compared with the PLB/CON groups, whereas the percentage of pores with erosion only was not different.
Summary · context
Cortical histomorphometry was performed on 60 bone biopsies from patients (aged 31 to 78 years) with chronic hypoparathyroidism randomized to either 100 μg rhPTH(1-84) a day (n = 21) (PTH)
Summary · context
This was followed by an open-label extension, where patients extended their rhPTH(1-84) (PTH) (n = 5), continued conventional treatment (CON) (n = 5), or withdrew from rhPTH(1-84) and resumed conventional therapy (PTHw) for an additional 24 months (n = 8).
Show in the study text Report a problemFND-3813074611
06HumanNon-randomized trialEfficacy outcome
In hypoparathyroidism, cortical microarchitecture with continued PTH did not differ from PTH withdrawal after 30 months.
In plain wordsIn hypoparathyroidism, cortical microarchitecture with continued PTH did not differ from PTH withdrawal after 30 months.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
No significant changeCortical microarchitecture versus withdrawal
Study
n = 13
Comparator
PTH withdrawal
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 μg a day · 30 monthsAs given in this study (human).
Source sentences
Summary
After 6 and 30 months, the overall cortical microarchitecture (cortical porosity, thickness, pore density, and mean pore diameter) in the PTH group did not differ from that of the PLB/CON and PTHw groups.
2 context sentences(design, population, supporting numbers)
Summary · context
Cortical histomorphometry was performed on 60 bone biopsies from patients (aged 31 to 78 years) with chronic hypoparathyroidism randomized to either 100 μg rhPTH(1-84) a day (n = 21) (PTH)
Summary · context
This was followed by an open-label extension, where patients extended their rhPTH(1-84) (PTH) (n = 5), continued conventional treatment (CON) (n = 5), or withdrew from rhPTH(1-84) and resumed conventional therapy (PTHw) for an additional 24 months (n = 8).
Show in the study text Report a problemFND-3813074603
07HumanNon-randomized trialEfficacy outcome
In hypoparathyroidism, PTH cortical microarchitecture did not differ from conventional treatment after 30 months.
In plain wordsIn hypoparathyroidism, PTH cortical microarchitecture did not differ from conventional treatment after 30 months.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
No significant changeCortical microarchitecture at thirty months
Study
n = 10
Comparator
Conventional treatment
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 μg a day · 30 monthsAs given in this study (human).
Source sentences
Summary
After 6 and 30 months, the overall cortical microarchitecture (cortical porosity, thickness, pore density, and mean pore diameter) in the PTH group did not differ from that of the PLB/CON and PTHw groups.
2 context sentences(design, population, supporting numbers)
Summary · context
Cortical histomorphometry was performed on 60 bone biopsies from patients (aged 31 to 78 years) with chronic hypoparathyroidism randomized to either 100 μg rhPTH(1-84) a day (n = 21) (PTH)
Summary · context
This was followed by an open-label extension, where patients extended their rhPTH(1-84) (PTH) (n = 5), continued conventional treatment (CON) (n = 5), or withdrew from rhPTH(1-84) and resumed conventional therapy (PTHw) for an additional 24 months (n = 8).
Show in the study text Report a problemFND-3813074602
08HumanNon-randomized trialEfficacy outcome
In hypoparathyroidism, PTH maintained a higher percentage of remodeling pores versus conventional treatment.
In plain wordsIn hypoparathyroidism, PTH maintained a higher percentage of remodeling pores versus conventional treatment.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreasePores undergoing remodeling at thirty months
Study
n = 10
Comparator
Conventional treatment
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 μg a day · 30 monthsAs given in this study (human).
Source sentences
Summary
Still, the PTH group had a significantly and persistently higher percentage of pores undergoing remodeling than the PLB/CON groups.
2 context sentences(design, population, supporting numbers)
Summary · context
Cortical histomorphometry was performed on 60 bone biopsies from patients (aged 31 to 78 years) with chronic hypoparathyroidism randomized to either 100 μg rhPTH(1-84) a day (n = 21) (PTH)
Summary · context
This was followed by an open-label extension, where patients extended their rhPTH(1-84) (PTH) (n = 5), continued conventional treatment (CON) (n = 5), or withdrew from rhPTH(1-84) and resumed conventional therapy (PTHw) for an additional 24 months (n = 8).
Show in the study text Report a problemFND-3813074605
09HumanNon-randomized trialEfficacy outcome
In hypoparathyroidism, PTH increased the percentage of formative pores versus conventional treatment.
In plain wordsIn hypoparathyroidism, PTH increased the percentage of formative pores versus conventional treatment.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreasePores undergoing bone formation at thirty months
Study
n = 10
Comparator
Conventional treatment
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 μg a day · 30 monthsAs given in this study (human).
Source sentences
Summary
A significantly higher percentage of these pores was undergoing bone formation in the PTH compared with the PLB/CON groups, whereas the percentage of pores with erosion only was not different.
2 context sentences(design, population, supporting numbers)
Summary · context
Cortical histomorphometry was performed on 60 bone biopsies from patients (aged 31 to 78 years) with chronic hypoparathyroidism randomized to either 100 μg rhPTH(1-84) a day (n = 21) (PTH)
Summary · context
This was followed by an open-label extension, where patients extended their rhPTH(1-84) (PTH) (n = 5), continued conventional treatment (CON) (n = 5), or withdrew from rhPTH(1-84) and resumed conventional therapy (PTHw) for an additional 24 months (n = 8).
Show in the study text Report a problemFND-3813074607
10HumanNon-randomized trialEfficacy outcome
In hypoparathyroidism, PTH did not change the percentage of erosion-only pores versus conventional treatment.
In plain wordsIn hypoparathyroidism, PTH did not change the percentage of erosion-only pores versus conventional treatment.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
No significant changePores with erosion only at thirty months
Study
n = 10
Comparator
Conventional treatment
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 μg a day · 30 monthsAs given in this study (human).
Source sentences
Summary
A significantly higher percentage of these pores was undergoing bone formation in the PTH compared with the PLB/CON groups, whereas the percentage of pores with erosion only was not different.
2 context sentences(design, population, supporting numbers)
Summary · context
Cortical histomorphometry was performed on 60 bone biopsies from patients (aged 31 to 78 years) with chronic hypoparathyroidism randomized to either 100 μg rhPTH(1-84) a day (n = 21) (PTH)
Summary · context
This was followed by an open-label extension, where patients extended their rhPTH(1-84) (PTH) (n = 5), continued conventional treatment (CON) (n = 5), or withdrew from rhPTH(1-84) and resumed conventional therapy (PTHw) for an additional 24 months (n = 8).
Show in the study text Report a problemFND-3813074609
11HumanNon-randomized trialEfficacy outcome
In hypoparathyroidism, PTH shifted the formative-to-eroded pore ratio toward formation versus conventional treatment after 30 months.
In plain wordsIn hypoparathyroidism, PTH shifted the balance of bone pores toward formation versus conventional treatment after 30 months.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
IncreaseFormative-to-eroded pore ratio at 30 months
Study
n = 10
Comparator
Conventional treatment
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 μg a day · 30 monthsAs given in this study (human).
Source sentences
Summary
This resulted in a shift in the ratio between formative and eroded pores, reflecting a faster transition from erosion to formation in the PTH-treated patients.
3 context sentences(design, population, supporting numbers)
Summary · context
A significantly higher percentage of these pores was undergoing bone formation in the PTH compared with the PLB/CON groups, whereas the percentage of pores with erosion only was not different.
Summary · context
Cortical histomorphometry was performed on 60 bone biopsies from patients (aged 31 to 78 years) with chronic hypoparathyroidism randomized to either 100 μg rhPTH(1-84) a day (n = 21) (PTH)
Summary · context
This was followed by an open-label extension, where patients extended their rhPTH(1-84) (PTH) (n = 5), continued conventional treatment (CON) (n = 5), or withdrew from rhPTH(1-84) and resumed conventional therapy (PTHw) for an additional 24 months (n = 8).
Show in the study text Report a problemFND-3813074612
12HumanNon-randomized trialEfficacy outcome
In hypoparathyroidism, prior PTH effects on remodeling and transition to formation reversed after withdrawal relative to conventional treatment.
In plain wordsIn hypoparathyroidism, prior PTH effects on remodeling reversed after withdrawal relative to conventional treatment.
Peptide
PTH 1-84 (parathyroid hormone)
Outcome
Direction not reportedRemodeling effects after withdrawal
Study
n: not reported in source
Comparator
PLB/CON groups (placebo or conventional treatment)
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated
Source sentences
Summary
In the rhPTH(1-84) withdrawal group PTHw, the latter effects of PTH were completely reversed in comparison to those of the PLB/CON groups.
3 context sentences(design, population, supporting numbers)
Summary · context
This resulted in a shift in the ratio between formative and eroded pores, reflecting a faster transition from erosion to formation in the PTH-treated patients.
Summary · context
Cortical histomorphometry was performed on 60 bone biopsies from patients (aged 31 to 78 years) with chronic hypoparathyroidism randomized to either 100 μg rhPTH(1-84) a day (n = 21) (PTH)
Summary · context
This was followed by an open-label extension, where patients extended their rhPTH(1-84) (PTH) (n = 5), continued conventional treatment (CON) (n = 5), or withdrew from rhPTH(1-84) and resumed conventional therapy (PTHw) for an additional 24 months (n = 8).
Show in the study text Report a problemFND-3813074610

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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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