A 12-Month Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01297309
First received: February 11, 2011
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

This study is a 12-month, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.


Condition Intervention Phase
Hypoparathyroidism
Drug: NPSP558
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12-Month Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)

Resource links provided by NLM:


Further study details as provided by NPS Pharmaceuticals:

Primary Outcome Measures:
  • A reduction in oral calcium or an oral calcium dose of ≤ 500 mg [ Time Frame: 52 weeks of treatment, 4 weeks of follow-up ] [ Designated as safety issue: Yes ]
  • A reduction in oral calcitriol to ≤ 0.25 μg [ Time Frame: 52 weeks of treatment, 4 weeks of follow-up ] [ Designated as safety issue: Yes ]
  • An albumin-corrected total serum calcium concentration that is normalized or maintained compared to the baseline value (≥7.5 mg/dL) and ULN [ Time Frame: 52 weeks of treatment, 4 weeks of follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPSP558 Drug: NPSP558
All patients will inject NPSP558 individual titration of 25, 50, 75 or 100 μg SC QD into alternating thighs in the morning via a multidose injection pen device.
Other Name: RACE

Detailed Description:

Patients with a history of Hypoparathyroidism will be enrolled to receive study drug for 52 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Hypoparathyroidism ≥ 18 months
  2. Adult males and females ages 18 to 85 years of age
  3. Able to perform daily SC self-injections of study medication
  4. Previously completed a NPSP558 study
  5. Women of childbearing potential need to use two methods of contraception.

Exclusion Criteria:

  1. Any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of PTH 1-84 and/or completing this trial
  2. Pregnant or lactating woman.
  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: NCT01297309

Locations
United States, California
Advance Medical Research LLC
Lakewood, California, United States, 90712
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
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, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
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
NPS Pharmaceuticals
Investigators
Study Director: Hjalmar Lagast, M.D. NPS Pharmaceuticals
  More Information

No publications provided

Responsible Party: NPS Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01297309     History of Changes
Other Study ID Numbers: PAR-C10-008
Study First Received: February 11, 2011
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by NPS Pharmaceuticals:
Hypoparathyroidism
NPSP558
Parathyroid Hormone 1-84
PTH 1-84

Additional relevant MeSH terms:
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014