Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism

What Was Tested

This registered phase 3 trial tested Parathyroid Hormone (PTH 1-84).

This study is open to adults with hypoparathyroidism who complete the SHP634-101 study (PARALLAX Study).

All participants enrolled in this study will receive rhPTH(1-84) once-daily for 52 weeks via an injection.

It had 1 arm (groups): rhPTH(1-84) (experimental).

The registry classes the interventions as biological.

Who Took Part

The registry lists 22 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: An understanding, ability, and willingness to fully comply with study procedures and restrictions. Ability to voluntarily provide written, signed, and dated informed consent to participate in the study. Previously completed the SHP634-101 (NCT02781844) study, including the 30-day follow-up. Male or non-pregnant, non-lactating female subjects who agree to comply with applicable contraceptive requirements of the protocol or females of non-childbearing potential.

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: received investigational study drug, aside from that received in study shp634-101 (nct02781844), within 3 months prior to the screening visit; received parathyroid hormone (pth), pth analog, or parathyroid hormone fragment 1-34 \[pth(1-34)\] treatment within the last 30 days from the screening visit; subjects with a history of parathyroid hormone intolerance, based on investigator determination.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Parathyroid Hormone (PTH 1-84) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-09-26 with completion listed for 2020-04-14.

It ran at 10 sites in United States (5), Canada (2), Hungary (2) and Denmark (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (time frame: From start of study drug administration to end of study (Week 56)). Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 24 (time frame: Week 24). Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 52 (EOT) (time frame: Week 52 (EOT)).

It also tracked 11 secondary outcomes, for example Change From Baseline in Albumin Corrected Serum Calcium (ACSC) Concentration at Weeks 24 and 52 (EOT), Change From Baseline in Serum Phosphate Concentration at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT), Change From Baseline in ACSC-phosphate Product at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT), Change From Baseline in 24-hour Urine Calcium Excretion at Weeks 16, 32 and 52 (EOT), Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase at Weeks 8, 24 and 52 (EOT) and Percentage Change From Baseline in Serum Osteocalcin at Weeks 8, 24 and 52 (EOT).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Parathyroid Hormone (PTH 1-84) in 22 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.