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

Hypoparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268098
• Other study ID #: PAR-C10-007
• Status: Completed
• Phase: Phase 3
• Start date: February 9, 2011
• Est. completion date: November 11, 2011

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 11, 2011
• Est. primary completion date: September 23, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Main 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.

Related Conditions & MeSH terms

• Hypoparathyroidism

Intervention

Drug:
• NPSP558
All patients will inject NPSP558 25 or 50 µg SC QD into alternating thighs in the morning via a multidose injection pen device.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Cincinnati Bone Health and Osteoporosis Center	Cincinnati	Ohio
United States	Michigan Bone & Mineral Clinic PC	Detroit	Michigan
United States	Physician East PA	Greenville	North Carolina
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Advance Medical Research LLC	Lakewood	California
United States	Columbia University Medical Center	New York	New York
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Cetero Research DGD Research Inc.	San Antonio	Texas
United States	University Physicians Group	Staten Island	New York
United States	The Vancouver Clinic	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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