Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)

Study Overview
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Brief Summary
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Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.

Detailed Description
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Patients with a history of Hypoparathyroidism will be randomized to receive study drug for 8 weeks, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically calcium levels in blood or urine). In addition, the patients' intake of Vitamin D and Calcium will be measured.

Official Title
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A Randomized, Dose-blinded Study to Investigate the Safety and Efficacy of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)], at Fixed Doses of 25 µg and 50 µg for the Treatment of Adults With Hypoparathyroidism

Conditions
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Hypoparathyroidism

Intervention / Treatment
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* Drug: NPSP558


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study With regard to female patients: women who are postmenopausal or willing to use two medically acceptable methods of contraception for the duration of the study with pregnancy testing conducted at every scheduled office visit Total serum calcium ≤ ULN based on local laboratory results prior to randomization Serum 25(OH) vitamin D ≤ 1.5 times the ULN within approximately 8 weeks prior to randomization Main Exclusion Criteria: Any disease or condition that, in the opinion of the investigator, has a high probability of precluding the patient from completing the study or being able to appropriately comply with study requirements Use of raloxifene hydrochloride or intravenous (IV) bisphosphonates since the end of participation in the REPLACE trial Chronic (ie, ≥ 1 month exposure) use of systemic corticosteroids, oral bisphosphonates, calcitonin, fluoride tablets, or cinacalcet hydrochloride Pregnant or lactating women Any condition that would, in the investigator's opinion in consultation with the sponsor, preclude the safe use of PTH Use of any experimental drug other than NPSP558 within 3 months of baseline.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25 µg dose<br>25 µg | Drug: NPSP558<br>* All patients will inject NPSP558 25 or 50 µg SC QD into alternating thighs in the morning via a multidose injection pen device.<br>* Other names: RELAY;|
| Experimental: 50 µg dose<br>50 µg | Drug: NPSP558<br>* All patients will inject NPSP558 25 or 50 µg SC QD into alternating thighs in the morning via a multidose injection pen device.<br>* Other names: RELAY;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. | The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data. | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8. | The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data | 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoparathyroidism, rhPTH[1-84], NPSP558