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

Phase 3

Completed

• Conditions: Hypoparathyroidism
• Interventions: Drug: NPSP558

• Registration Number: NCT01268098
• Lead Sponsor: Shire

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-12-28
• Study First Submitted QC: 2010-12-28
• Study First Posted: 2010-12-29
• Study Start: 2011-02-09
• Primary Completion: 2011-09-23
• Study Completion: 2011-11-11
• Disposition First Submitted: 2012-09-21
• Disposition First Submitted QC: 2012-09-21
• Disposition First Posted: 2012-10-01
• Results First Submitted: 2015-02-20
• Results First Submitted QC: 2015-02-20
• Results First Posted: 2015-03-06
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-04
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study
2. 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
3. Total serum calcium ≤ ULN based on local laboratory results prior to randomization
4. Serum 25(OH) vitamin D ≤ 1.5 times the ULN within approximately 8 weeks prior to randomization

Main

Exclusion Criteria

1. 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
2. Use of raloxifene hydrochloride or intravenous (IV) bisphosphonates since the end of participation in the REPLACE trial
3. Chronic (ie, ≥ 1 month exposure) use of systemic corticosteroids, oral bisphosphonates, calcitonin, fluoride tablets, or cinacalcet hydrochloride
4. Pregnant or lactating women
5. Any condition that would, in the investigator's opinion in consultation with the sponsor, preclude the safe use of PTH
6. Use of any experimental drug other than NPSP558 within 3 months of baseline.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25 µg dose	NPSP558	25 µg
50 µg dose	NPSP558	50 µg

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.	8 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.	8 Weeks	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

Trial Locations

Locations (12)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Michigan Bone & Mineral Clinic PC; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Cetero Research DGD Research Inc.; 🇺🇸 San Antonio, Texas, United States

Advance Medical Research LLC; 🇺🇸 Lakewood, California, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

University of Cincinnati Bone Health and Osteoporosis Center; 🇺🇸 Cincinnati, Ohio, United States

Physician East PA; 🇺🇸 Greenville, North Carolina, United States

University Physicians Group; 🇺🇸 Staten Island, New York, United States

The Vancouver Clinic; 🇺🇸 Vancouver, Washington, United States