A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism (NCT02910466) | Clinical Trial Compass
CompletedPhase 4
A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism
United States39 participantsStarted 2016-10-27
Plain-language summary
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. This study is designed to extend this experience and gain knowledge about how safe and effective rhPTH(1-84) is in participants with hypoparathyroidism over a long-term duration.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Participants that are currently or previously enrolled in the core study (AAAE0544 \[NCT01199614\]) and have maintained uninterrupted therapy with recombinant human parathyroid hormone (rhPTH(1-84)) (transient interruptions of up to 1 month continuously off treatment may be allowed).
* Signed and dated informed consent form (ICF).
* Adult men and women 18 to 85 years of age.
* History of hypoparathyroidism for at least 12 months prior to rhPTH(1-84) treatment, defined by the requirement for supplemental calcium and/or active vitamin D to maintain serum calcium along with an undetectable or insufficient Parathyroid hormone (PTH) concentration.
* 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.
Exclusion Criteria
* 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.
* The participant is unable to comply with the protocol, example, uncoop…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 6
Timeframe: Baseline (402), Month 6
2
Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 12
Timeframe: Baseline (402), Month 12
3
Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 18
Timeframe: Baseline (402), Month 18
4
Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 24
Timeframe: Baseline (402), Month 24
5
Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 30
Timeframe: Baseline (402), Month 30
6
Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 36
Timeframe: Baseline (402), Month 36
7
Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at End of Treatment (EOT) (up to Month 36)