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A 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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01297309
Recruitment Status : Completed
First Posted : February 16, 2011
Results First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.

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

Detailed Description:
Patients with a history of Hypoparathyroidism will be enrolled to receive study drug for up to 80 months, 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term 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)
Actual Study Start Date : April 6, 2011
Actual Primary Completion Date : June 8, 2018
Actual Study Completion Date : June 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: NPSP558
titration of 25, 50, 75 or 100 μg
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




Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) [ Time Frame: From start of study drug administration up to follow-up (82 months) ]
    SAE is an adverse event (AE) that results in death, life threatening, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, hospitalization or prolongation of existing hospitalization, congenital anomaly or birth defect, important medical events that may not result in death, be life threatening, or require hospitalization. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical or medicinal product. Treatment emergent adverse events (TEAEs) were defined as AEs whose onset occurs, severity worsens or intensity increases after receiving the study medication of this study and <= 30 days after last dose of study drug.

  2. Number of Responders With Calcium Source at Week 52 [ Time Frame: Week 52 ]
    A responder was defined as a participant who met all of the following 3 criteria at each (1) a greater than (>) 50% reduction from baseline or less than (<) 500 milligram (mg) of daily calcium supplementation. (2) a >50% reduction from baseline or <0.25 microgram (mcg) of daily calcitriol supplementation. (3) an albumin-corrected total serum calcium concentration that was normalized or maintained compared to the baseline greater than or equal to (>=) 1.875 millimoles per liter (mmol/L) and not exceeding the Upper Limit of Normal (ULN) values (2.15 to 2.55 mmol/L). End of Treatment (EOT) was defined as the last determination of response or last available measurement during the treatment period. Number of responders with calcium source for citrate and carbonate at week 52 was reported here.

  3. Number of Responders With Calcium Source at End Of Treatment (EOT) (Up to 82 Months) [ Time Frame: EOT (up to 82 months) ]
    A responder was defined as a participant who met all of the following 3 criteria at each (1) a greater than (>) 50% reduction from baseline or less than (<) 500 milligram (mg) of daily calcium supplementation. (2) a >50% reduction from baseline or <0.25 microgram (mcg) of daily calcitriol supplementation. (3) an albumin-corrected total serum calcium concentration that was normalized or maintained compared to the baseline greater than or equal to (>=) 1.875 millimoles per liter (mmol/L) and not exceeding the Upper Limit of Normal (ULN) values (2.15 to 2.55 mmol/L). End of Treatment (EOT) was defined as the last determination of response or last available measurement during the treatment period. Number of responders with calcium source for citrate and carbonate at EOT was reported here.


Secondary Outcome Measures :
  1. Percent Change From Baseline in Oral Calcium Supplementation at Week 52 and EOT (Up to 82 Months) [ Time Frame: Baseline, Week 52 and EOT (up to 82 months) ]
    Percent change from baseline of oral calcium supplementation were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.

  2. Percent Change From Baseline in Oral Calcitriol Supplementation at Week 52 and EOT (Up to 82 Months) [ Time Frame: Baseline, Week 52 and EOT (up to 82 months) ]
    Percent change from baseline of oral calcitriol supplementation were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.

  3. Percent Change From Baseline in Albumin Corrected Total Serum Calcium (ACSC) at EOT (Up to 82 Months) [ Time Frame: Baseline, EOT (up to 82 months) ]
    Percent change in ACSC was reported. EOT was defined as the last determination of response or last available measurement during the treatment period.

  4. Change From Baseline in 24-Hour Urine Calcium Excretion Through EOT (Up to 82 Months) [ Time Frame: Baseline, EOT (up to 82 months) ]
    Change in 24 hour urine calcium excretion was reported. EOT was defined as the last determination of response or last available measurement during the treatment period.

  5. Change From Baseline in 24-hour Urine Calcium Excretion in Participants Who Used Calcium-Sparing Diuretics Through EOT (Up to 82 Months) [ Time Frame: Baseline, EOT (up to 82 months) ]
    Change from baseline in urinary calcium concentration in participants who used at least one calcium-sparing diuretics and participants who not used calcium-sparing diuretics were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.

  6. Change From Baseline in Serum Calcium Concentration in Participants Who Used and Calcium Sparing Diuretics at EOT (Upto 82 Months) [ Time Frame: Baseline, EOT (upto 82 months) ]
    Change in serum calcium concentration of the number of participants who used at least one calcium-sparing diuretics and not used calcium sparing diuretics were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.

  7. Change From Baseline in Serum Phosphate at Month 72 and EOT (Upto 82 Months) [ Time Frame: Baseline, Month 72, EOT (upto 82 months) ]
    Change of serum phosphate from baseline were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.

  8. Number of Participants Who Maintained a Calcium Phosphate Product in A Normal Range at EOT (Up to 82 Months) [ Time Frame: EOT (up to 82 months) ]
    The normal range of calcium phosphate product is defined as <= 4.441 millimoles square per liter square (mmol^2/L^2).

  9. Change From Baseline in Bone Turnover Markers at EOT (Up to 82 Months) [ Time Frame: Baseline, EOT (up to 82 months) ]
    Bone Turnover Markers such as bone specific alkaline phosphatase (BSAP), serum procollagen type 1 amino-terminal propeptide (P1NP) , osteocalcin were reported in particpiants. EOT was defined as the last determination of response or last available measurement during the treatment period.

  10. Change From Baseline in Serum Carboxy Terminal Telopeptide of Type I Collagen (s-CTx) Bone Turnover Marker at EOT (Up to 82 Months) [ Time Frame: Baseline, EOT (up to 82 months) ]
    Change form baseline in bone turnover marker (s-CTx)was reported. EOT was defined as the last determination of response or last available measurement during the treatment period.

  11. Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) [ Time Frame: Baseline, Week 52 and EOT (up to 82 months) ]
    Change from baseline in BMD of lumbar spine (L1-L4), hip-total, hip-trochanter, hip-intertrochanter, hip-ward's triangle, hip-femoral neck, distal one third radius at Week 52 then every 12 months until EOT were assessed by dual-energy X-ray absorptiometry [DXA] and Z-score. EOT was defined as the last determination of response or last available measurement during the treatment period.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Previously completed the rhPTH[1-84] RELAY study (8 weeks of active therapy) and/or previously completed the rhPTH[1-84] REPLACE study (Visit 18).
  • Able to perform daily SC self-injections of study medication (or have a designee perform injection).
  • Women who are (1) postmenopausal; (2) surgically sterilized; or, (3) of childbearing potential with a negative pregnancy test and who consent to use two acceptable methods of contraception for the duration of the study.
  • Males who have female partners of childbearing potential must use two acceptable forms of contraception for the duration of the study.
  • Serum creatinine <1.5 mg/dL at enrollment.
  • Total serum calcium less than or equal to upper limit of normal (ULN) based on local laboratory result prior to enrollment.
  • Serum 25 hydroxy (OH) vitamin D less than or equal to 1.5 times the ULN within approximately 16 weeks prior to enrollment.

Exclusion Criteria:

  • Any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of parathyroid hormone (PTH).
  • Pregnant or lactating women.
  • Any disease or condition which has a high probability of precluding the subject from completing the study or where the subject cannot or will not appropriately comply with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297309


Locations
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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
Shire
Investigators
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Study Director: Study Director Shire
  Study Documents (Full-Text)

Documents provided by Shire:
Study Protocol: Original Protocol  [PDF] December 30, 2010
Study Protocol: Protocol Amendment 1  [PDF] June 29, 2011
Study Protocol: Protocol Amendment 2  [PDF] October 5, 2011
Study Protocol: Protocol Amendment 3  [PDF] March 15, 2012
Study Protocol: Protocol Amendment 6  [PDF] October 24, 2016
Statistical Analysis Plan  [PDF] March 22, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01297309    
Other Study ID Numbers: PAR-C10-008
First Posted: February 16, 2011    Key Record Dates
Results First Posted: August 6, 2019
Last Update Posted: August 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.shiretrials.com website. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://www.shiretrials.com/en/our-commitment-to-transparency/data-sharing-with-researchers
Keywords provided by Shire:
PTH 1-84
Hypoparathyroidism
Parathyroid Hormone 1-84
NPSP558
Additional relevant MeSH terms:
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Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases