A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism

What Was Tested

The trial (phase 4) is built around Parathyroid Hormone (PTH 1-84).

Chronic hypoparathyroidism is a life-long and irreversible disease for which the chronic administration of rhPTH(1-84) is a potential treatment option.

The group of participants in the AAAE0544 core study has been taking rhPTH(1-84) for the treatment of hypoparathyroidism for up to 11 years.

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

The registry classes the interventions as drug.

Who Took Part

39 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Signed and dated informed consent form (ICF). Adult men and women 18 to 85 years of age. Able to perform daily subcutaneous (SC) self-injections of study medication (or have designee perform injection). Willingness and ability to understand and comply with the protocol. Women must agree to pregnancy testing and acceptable methods of contraception, as detailed in the protocol.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: the participant is treated or has been treated with any investigational drug, aside from rhpth(1-84), within 30 days of consent; as assessed by the investigator, the participant has any safety or medical issues that contraindicate participation in the study; the participant and/or the participant's parent(s) or legally-authorized representative(s) are unable to understand the nature, scope, and possible consequences of the study.

How the Study Was Run

The set-up was 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 2016-10-27 with completion listed for 2019-12-20.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 6 (time frame: Baseline (402), Month 6). Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 12 (time frame: Baseline (402), Month 12). Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 18 (time frame: Baseline (402), Month 18).

It also tracked 19 secondary outcomes, for example Change From Baseline (402) in Urinary Calcium Excretion at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36), Change From Baseline (402) in Concentration of Serum Phosphate Levels at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36), Change From Baseline (402) in Hypoparathyroidism Symptoms Diary (HPT-SD) at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36), Change From Baseline (402) in Hospital Anxiety and Depression Scale (HADS) at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36), Change From Baseline (402) in Concentration of Bone Turnover Markers at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) and Mean Bone Histology (Biopsy) of Adjusted Apposition Rate and Cancellous Minimum Apposition Rate at Month 12, and EOT (up to Month 36).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Parathyroid Hormone (PTH 1-84) in 39 people.

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

The trial is marked completed; 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.