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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01268098
First received: December 28, 2010
Last updated: November 10, 2015
Last verified: March 2015
History of Changes
  Purpose
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 Intervention Phase
Hypoparathyroidism
 Drug: NPSP558
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shire:

Primary Outcome Measures:
  • Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    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:
  • The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    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
Enrollment: 42
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268098

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

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01268098     History of Changes
Other Study ID Numbers: PAR-C10-007 
Study First Received: December 28, 2010
Results First Received: February 20, 2015
Last Updated: November 10, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
Hypoparathyroidism, rhPTH[1-84], NPSP558

Additional relevant MeSH terms:
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 26, 2016