A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)

PHASE4CompletedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

January 24, 2018

Primary Completion Date

May 19, 2022

Study Completion Date

May 19, 2022

Conditions
Hypoparathyroidism
Interventions
BIOLOGICAL

rhPTH (1-84)

rhPTH (1-84) SC injection.

BIOLOGICAL

Placebo

Placebo QD SC injection.

Trial Locations (40)

128

Università Campus Bio Medico Di Roma, Roma

372

Oslo Universitetssykehus HF Rikshospitalet, Oslo

1307

Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden

3000

UZ Leuven, Leuven

5000

Odense Universitetshospital, Odense C

5021

Haukeland Universitetssykehus, Bergen

8200

Aarhus Universitetshospital, Aarhus N

9000

UZ Gent, Ghent

19104

Children's Hospital of Philadelphia, Philadelphia

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

25030

Hopital Jean Minjoz, Besançon

27834

Physicians East PA, Greenville

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28223

Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón

41345

Sahlgrenska Universitetssjukhuset, Gothenburg

43203

Ohio State University Wexner Medical Center, Columbus

48236

Michigan Bone and Mineral Clinic, Detroit

49933

CHU Angers, Angers

50139

Universita di Firenze, Dipartimento di Chirurgia e Medicina Traslazionale (DCMT), Florence

55905

Mayo Clinic - PPDS, Rochester

59000

CHRU Lille, Lille

60637

University of Chicago, Chicago

94275

CHU Bicêtre, Le Kremlin-Bicêtre

B3H 1V7

Nova Scotia Health Authority (Capital District Health Authority), Halifax

L6M 1M1

Bone Research and Education Centre, Oakville

G1J 1Z4

CHU de Quebec-Universite Laval, Québec

A1B3V6

Eastern Health - Health Sciences Center- General Hospital, St. John's

1081 HV

VU Medisch Centrum, Amsterdam

2300 RC

Leids Universitair Medisch Centrum, Leiden

N-0514

Oslo Universitetssykehus Aker, Oslo

3000-075

Centro Hospitalar E Universitário de Coimbra EPE, Coimbra

4464-513

Unidade Local de Saúde de Matosinhos SA, Matosinhos Municipality

4200-319

Centro Hospitalar de São João, E.P.E., Porto

Unknown

C.H. Regional Reina Sofia - PPDS, Córdoba

DD1 9SY

Ninewells Hospital - PPDS, Dundee

NR4 7UY

Norfolk and Norwich University Hospital, Norwich

B15 2TH

Queen Elizabeth Hospital, Birmingham

LE1 5WW

Leicester Royal Infirmary, Leicester

M13 9WL

Manchester Royal Infirmary - PPDS, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT03324880 - A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE) | Biotech Hunter | Biotech Hunter