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

• ClinicalTrials.gov Identifier: NCT01268098
• Recruitment Status: Completed
• First Posted: December 29, 2010
• Results First Posted: March 6, 2015
• Last Update Posted: December 8, 2015
• Sponsor: Shire
• Information provided by (Responsible Party): Shire

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypoparathyroidism	Drug: NPSP558	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: January 2011
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: November 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: 25 µg dose; 25 µg	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.; Other Name: RELAY
Experimental: 50 µg dose; 50 µg	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.; Other Name: RELAY

Outcome Measures

Primary Outcome Measures :

1. Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. [ Time Frame: 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 :

1. The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8. [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

Advance Medical Research LLC

Lakewood, California, United States, 90712

United States, Illinois

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

United States, Indiana

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

United States, Michigan

Michigan Bone & Mineral Clinic PC

Detroit, Michigan, United States, 48236

United States, Minnesota

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

University Physicians Group

Staten Island, New York, United States, 10301

United States, North Carolina

Physician East PA

Greenville, North Carolina, United States, 27834

United States, Ohio

University of Cincinnati Bone Health and Osteoporosis Center

Cincinnati, Ohio, United States, 45219

United States, Texas

Cetero Research DGD Research Inc.

San Antonio, Texas, United States, 78229

United States, Washington

The Vancouver Clinic

Vancouver, Washington, United States, 98664

Sponsors and Collaborators

Shire

Investigators

• Study Director: Hjalmar Lagast, M.D.; NPS Pharma

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bilezikian JP, Clarke BL, Mannstadt M, Rothman J, Vokes T, Lee HM, Krasner A. Safety and Efficacy of Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism Randomly Assigned to Receive Fixed 25-μg or 50-μg Daily Doses. Clin Ther. 2017 Oct;39(10):2096-2102. doi: 10.1016/j.clinthera.2017.08.011. Epub 2017 Sep 21.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT01268098
• Other Study ID Numbers: PAR-C10-007
• First Posted: December 29, 2010
• Results First Posted: March 6, 2015
• Last Update Posted: December 8, 2015
• Last Verified: March 2015

Keywords provided by Shire:

Hypoparathyroidism, rhPTH[1-84], NPSP558

Additional relevant MeSH terms:

Hypoparathyroidism; Parathyroid Diseases; Endocrine System Diseases