NCT01268098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

February 9, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2011

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

March 6, 2015

Completed
Last Updated

June 11, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

December 28, 2010

Results QC Date

February 20, 2015

Last Update Submit

June 4, 2021

Conditions

Hypoparathyroidism

Keywords

Hypoparathyroidism, rhPTH[1-84], NPSP558

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.

    8 Weeks

Study Arms (2)

25 µg dose

EXPERIMENTAL

25 µg

Drug: NPSP558

50 µg dose

EXPERIMENTAL

50 µg

Drug: NPSP558

Interventions

NPSP558DRUG

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

Also known as: RELAY
25 µg dose50 µg dose

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study
  • 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
  • Total serum calcium ≤ ULN based on local laboratory results prior to randomization
  • Serum 25(OH) vitamin D ≤ 1.5 times the ULN within approximately 8 weeks prior to randomization

You may not qualify if:

  • 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
  • Use of raloxifene hydrochloride or intravenous (IV) bisphosphonates since the end of participation in the REPLACE trial
  • Chronic (ie, ≥ 1 month exposure) use of systemic corticosteroids, oral bisphosphonates, calcitonin, fluoride tablets, or cinacalcet hydrochloride
  • Pregnant or lactating women
  • Any condition that would, in the investigator's opinion in consultation with the sponsor, preclude the safe use of PTH
  • Use of any experimental drug other than NPSP558 within 3 months of baseline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Advance Medical Research LLC

Lakewood, California, 90712, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Michigan Bone & Mineral Clinic PC

Detroit, Michigan, 48236, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University Physicians Group

Staten Island, New York, 10301, United States

Location

Physician East PA

Greenville, North Carolina, 27834, United States

Location

University of Cincinnati Bone Health and Osteoporosis Center

Cincinnati, Ohio, 45219, United States

Location

Cetero Research DGD Research Inc.

San Antonio, Texas, 78229, United States

Location

The Vancouver Clinic

Vancouver, Washington, 98664, United States

Location

Related Publications (5)

  • Ayodele O, Rejnmark L, Mu F, Lax A, Berman R, Swallow E, Gosmanova EO. Five-Year Estimated Glomerular Filtration Rate in Adults with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study. Adv Ther. 2022 Nov;39(11):5013-5024. doi: 10.1007/s12325-022-02292-1. Epub 2022 Aug 26.

    PMID: 36018496DERIVED

  • Rejnmark L, Ayodele O, Lax A, Mu F, Swallow E, Gosmanova EO. The risk of chronic kidney disease development in adult patients with chronic hypoparathyroidism treated with rhPTH(1-84): A retrospective cohort study. Clin Endocrinol (Oxf). 2023 Apr;98(4):496-504. doi: 10.1111/cen.14813. Epub 2022 Aug 28.

    PMID: 35974422DERIVED

  • Ayodele O, Mu F, Berman R, Swallow E, Rejnmark L, Gosmanova EO, Kaul S. Lower Risk of Cardiovascular Events in Adult Patients with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study. Adv Ther. 2022 Aug;39(8):3845-3856. doi: 10.1007/s12325-022-02198-y. Epub 2022 Jun 11.

    PMID: 35696069DERIVED

  • Chen KS, Gosmanova EO, Curhan GC, Ketteler M, Rubin M, Swallow E, Zhao J, Wang J, Sherry N, Krasner A, Bilezikian JP. Five-year Estimated Glomerular Filtration Rate in Patients With Hypoparathyroidism Treated With and Without rhPTH(1-84). J Clin Endocrinol Metab. 2020 Oct 1;105(10):e3557-65. doi: 10.1210/clinem/dgaa490.

    PMID: 32738041DERIVED

  • 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-mug or 50-mug Daily Doses. Clin Ther. 2017 Oct;39(10):2096-2102. doi: 10.1016/j.clinthera.2017.08.011. Epub 2017 Sep 21.

    PMID: 28942334DERIVED

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Results Point of Contact

Title
Study Director
Organization
Shire
ClinicalTransparency@shire.com
+1 866 842 5335

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2010

First Posted

December 29, 2010

Study Start

February 9, 2011

Primary Completion

September 23, 2011

Study Completion

November 11, 2011

Last Updated

June 11, 2021

Results First Posted

March 6, 2015

Record last verified: 2021-06

Locations

US(12)