Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04921124
Status:
COMPLETED
Last Update Posted:
2021-08-12
First Post:
2021-05-19
Brief Title:
Pharmacokinetic and PHarmacodynamic Analysis and Evaluation of Teriparatide PTH 1-34 Between Sexes
Sponsor:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Organization:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Study Overview
Official Title:
Pharmacokinetic and PHarmacodynamic Analysis and Evaluation of Teriparatide PTH 1-34 Between Sexes
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHAB
Brief Summary:
To test for a difference in the pharmacokinetics PK and pharmacodynamics PD of teriparatide PTH 1-34 between healthy male and female volunteers matched to military recruits in training
Detailed Description:
Teriparatide first licensed for fracture prevention in osteoporosis in 2003 is a human recombinant preparation of parathyroid hormone PTH 1-34 The licensed dose is a 20 µg sub-cutaneous SC injection delivered once daily using a pre-filled pen Published pharmacokinetic PK and pharmacodynamic PD data focus on administration in adult female pre-menopausal women Eli Lilly did not publish their original First in Human data therefore there is a lack of available data in men The patent on the Eli Lilly formulation expired in August 2019 and three teriparatide biosimilars have been released onto the UK market Gedeon Richter and Thornton and Ross presented data in osteoporotic patients to the MHRA to license their products as biosimilars Teriparatide has also been investigated in the treatment of stress fractures but there are no published data comparing the PKs and PDs of these drugs in a population equivalent to individuals undergoing military training ie young healthy men and women
Existing data to support the equivalence of teriparatide between sexes is limited Citrate and calcium infusions have been used to characterise the impact of sex differences on PTH dynamics in twelve women with mean age SD of 264 16 years and 12 men with mean age of 266 13 years They reported no between sex differences in serum PTH concentrations It has also been reported that 2-weeks of intermittent PTH administration in mice was anabolic for cortical bone with a greater effect observed in male compared with female animals No studies have investigated between sex PK or PD differences or efficacy of teriparatide injection in humans By examining this the present study will help to further our understanding of how teriparatide can be used in men and women
A review considering a number of trials supported the use of PTH in its licensed indications and demonstrated the efficacy of this drug in both male and female subjects The evidence base cited in this review is primarily from post-menopausal women in line with the licensed indication
This study compliments the RETURN trial which is investigating the efficacy of teriparatide for accelerating stress fracture healing in Army infantry recruits EudraCT 2018-002130-20 The study is based at the Infantry Training Centre ITC which currently predominantly trains men hence men will form the majority of the RETURN study participants Opening front line roles to women comes with a well-documented risk of musculoskeletal injury due to the nature of infantry training HQ Army 2016 If the results of the RETURN trial are to be extrapolated to women and inform Defence treatment policy for stress fractures the between sex differences in PK and PD in a population matched to individuals in military training must be established This study is required if the results of RETURN are to be extrapolated to a female population undergoing military training
The Gedeon Richter preparation Terossa will be used in this study as this is the preparation that is being used in the RETURN study This will control for inter-brand variation
Nephrogenous cyclic Adenosine Mono Phosphate is a measurement of PTH 1-34 activity at the kidney and can therefore be used to estimate the early biological effects of PTH 1-34 in humans
The research questions are
1 Is there a difference in the PK or PD profile of teriparatide subcutaneous injection between men and women
2 Are the PK and PD measurements reliable and reproducible The cohort for investigation is young healthy free from immune cardiovascular or metabolic diseases men and women military or physically trained civilians free from illness and matched to a military population in training based on age body mass index BMI and absence of medical conditions that would be a bar to entry to the Army Can I Join The Army Find Out if You Are Eligible British Army - British Army Jobs moduk Accessed 16012021
The intervention involves a single dose of teriparatide administered on 2 occasions
Participants will be closely monitored for 12 hours plus a further 12 hours urine collection followed by a 24-hour washout period
Existing data to support the equivalence of teriparatide between sexes is limited Citrate and calcium infusions have been used to characterise the impact of sex differences on PTH dynamics in twelve women with mean age SD of 264 16 years and 12 men with mean age of 266 13 years They reported no between sex differences in serum PTH concentrations It has also been reported that 2-weeks of intermittent PTH administration in mice was anabolic for cortical bone with a greater effect observed in male compared with female animals No studies have investigated between sex PK or PD differences or efficacy of teriparatide injection in humans By examining this the present study will help to further our understanding of how teriparatide can be used in men and women
A review considering a number of trials supported the use of PTH in its licensed indications and demonstrated the efficacy of this drug in both male and female subjects The evidence base cited in this review is primarily from post-menopausal women in line with the licensed indication
This study compliments the RETURN trial which is investigating the efficacy of teriparatide for accelerating stress fracture healing in Army infantry recruits EudraCT 2018-002130-20 The study is based at the Infantry Training Centre ITC which currently predominantly trains men hence men will form the majority of the RETURN study participants Opening front line roles to women comes with a well-documented risk of musculoskeletal injury due to the nature of infantry training HQ Army 2016 If the results of the RETURN trial are to be extrapolated to women and inform Defence treatment policy for stress fractures the between sex differences in PK and PD in a population matched to individuals in military training must be established This study is required if the results of RETURN are to be extrapolated to a female population undergoing military training
The Gedeon Richter preparation Terossa will be used in this study as this is the preparation that is being used in the RETURN study This will control for inter-brand variation
Nephrogenous cyclic Adenosine Mono Phosphate is a measurement of PTH 1-34 activity at the kidney and can therefore be used to estimate the early biological effects of PTH 1-34 in humans
The research questions are
1 Is there a difference in the PK or PD profile of teriparatide subcutaneous injection between men and women
2 Are the PK and PD measurements reliable and reproducible The cohort for investigation is young healthy free from immune cardiovascular or metabolic diseases men and women military or physically trained civilians free from illness and matched to a military population in training based on age body mass index BMI and absence of medical conditions that would be a bar to entry to the Army Can I Join The Army Find Out if You Are Eligible British Army - British Army Jobs moduk Accessed 16012021
The intervention involves a single dose of teriparatide administered on 2 occasions
Participants will be closely monitored for 12 hours plus a further 12 hours urine collection followed by a 24-hour washout period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None