This study is open to adults with hypoparathyroidism who complete the SHP634-101 study (PARALLAX Study). The purpose of this study is to see if rhPTH(1-84) is safe and effective in adults with hypoparathyroidism who previously participated in the SHP634-101 study. All participants enrolled in this study will receive rhPTH(1-84) once-daily for 52 weeks via an injection. Patients who complete the SHP634-101 study will have the option to screen for this extension study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Participants will receive rhPTH(1-84) SC injection in the thigh (alternate thigh every day) QD.
University of Kentucky Medical Center
Lexington, Kentucky, United States
Crescent City Clinical Research Center, LLC
Metairie, Louisiana, United States
Northern Nevada Endocrinology - Lisa Abbott MD
Reno, Nevada, United States
Percentage of Participants Who Achieved Total Albumin-corrected Serum Calcium (ACSC) Values Greater Than or Equal to (>=) to the Range of 7.5 mg/dL (1.875 mmol/L) and Less Than or Equal to (<=) Upper Limit of Normal (ULN) at Week 24
Percentage of participants who achieved ACSC values \>= to range of 1.875 mmol/L and \<= ULN at Week 24 was reported.
Time frame: At Week 24
Percentage of Participants With Total ACSC Values >= to the Range of 7.5 mg/dL (1.875 mmol/L) and <=ULN at Week 52 (End-of-treatment [EOT])
Percentage of participants who achieved ACSC values \>= to range of 1.875 mmol/L and \<= ULN at Week 52 (EOT) was reported.
Time frame: At Week 52 (EOT)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, and is an important medical event. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose.
Time frame: From start of study drug administration to end of study (Week 56)
Number of Participants With Clinically Significant Change in Clinical Laboratory Values
Clinical laboratory assessment included hematology, serum chemistry, urine chemistry and urinalysis. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any changes in clinical laboratory results which were deemed clinically significant by the investigator was reported.
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Ohio State University
Columbus, Ohio, United States
Thomas Jefferson University, Jefferson Rheumatology Associates
Philadelphia, Pennsylvania, United States
Bone Research and Education Centre
Oakville, Ontario, Canada
CHU de Quebec-Universite Laval
Québec, Canada
Aarhus Universitetshospital
Aarhus N, Denmark
Semmelweis Egyetem
Budapest, Hungary
Pecsi Tudomanyegyetem, I. sz. Belgyogyaszati Klinika
Pécs, Hungary
Time frame: From start of study drug administration to end of study (Week 56)
Number of Participants With Clinically Significant Change in Vital Sign
Vital sign parameters included: temperature, pulse rate, respiration rate, systolic and diastolic blood pressure. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any changes in vital signs which were deemed clinically significant by the investigator was reported.
Time frame: From start of study drug administration to end of study (Week 56)
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters
Twelve-lead ECGs was performed in triplicate with a minimum 2-minute gap between traces. The participant rested in the supine position for at least 5 minutes before collecting the ECG. Assessment of ECG parameters included: heart rate, RR interval, PR interval, QRS interval, QT interval, and QTc interval. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any change in ECG assessments which were deemed clinically significant by the investigator was reported.
Time frame: From start of study drug administration to end of study (Week 56)
Number of Participants With Clinically Significant Change in Estimated Glomerular Filtration Rate (eGFR) Values
eGFR was calculated using the chronic kidney disease epidemiology (CDK-epi) formula. Clinical significance was judged by the investigator based upon the out of range values of standard range set for parameter. Any change in eGFR assessments which were deemed clinically significant by the investigator was reported.
Time frame: From start of study drug administration to end of study (Week 56)
Number of Participants With Clinically Significant Change in Serum Creatinine Value
eGFR was assessed by measuring serum creatinine. Serum creatinine level was obtained directly from laboratory results. Clinical significance was judged by the investigator based upon the out of range values of standard range set for parameter. Any change in serum creatinine assessments which were deemed clinically significant by the investigator was reported.
Time frame: From start of study drug administration to end of study (Week 56)
Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 24
Number of participants with positive anti-parathyroid hormone antibodies at Week 24 was reported.
Time frame: Week 24
Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 52 (EOT)
Number of participants with positive anti-parathyroid hormone antibodies at Week 52 (EOT) was reported.
Time frame: Week 52 (EOT)
Change From Baseline in Albumin Corrected Serum Calcium (ACSC) Concentration at Weeks 24 and 52 (EOT)
Change from baseline in ACSC concentration at Weeks 24 and 52 (EOT) was reported.
Time frame: Baseline, Weeks 24 and 52 (EOT)
Change From Baseline in Serum Phosphate Concentration at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)
Change from baseline in serum phosphate concentration at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) was reported.
Time frame: Baseline, Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)
Change From Baseline in ACSC-phosphate Product at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)
Change from baseline in ACSC-phosphate product at Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT) was reported. Here "mmol\^2/L\^2" is abbreviated as millimoles square per liter square.
Time frame: Baseline, Weeks 4, 8, 16, 24, 32, 40 and 52 (EOT)
Change From Baseline in 24-hour Urine Calcium Excretion at Weeks 16, 32 and 52 (EOT)
Change from baseline in 24-hour urine calcium excretion at Weeks 16, 32 and 52 (EOT) was reported.
Time frame: Baseline, Weeks 16, 32 and 52 (EOT)
Percentage Change From Baseline in Prescribed Supplemental Oral Calcium Dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (End of Study [EOS])
Percentage change from baseline in prescribed supplemental oral calcium dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) were reported.
Time frame: Baseline and at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS)
Percentage Change From Baseline in Prescribed Supplemental Active Vitamin D Dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS)
Percentage change from baseline in prescribed supplemental oral calcium dose at Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS) were reported.
Time frame: Baseline, Weeks 4, 8, 16, 24, 32, 40, 52 (EOT) and 56 (EOS)
Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase at Weeks 8, 24 and 52 (EOT)
Percentage change from baseline in serum bone-specific alkaline phosphatase at Weeks 8, 24 and 52 (EOT) was reported.
Time frame: Baseline, Weeks 8, 24 and 52 (EOT)
Percentage Change From Baseline in Serum Osteocalcin at Weeks 8, 24 and 52 (EOT)
Percentage change from baseline in serum osteocalcin at Weeks 8, 24 and 52 (EOT) was reported.
Time frame: Baseline, Weeks 8, 24 and 52 (EOT)
Percentage Change From Baseline in Procollagen 1 N-Terminal Propeptide at Weeks 8, 24 and 52 (EOT)
Percentage change from baseline in procollagen 1 N-terminal propeptide at Weeks 8, 24 and 52 (EOT) was reported.
Time frame: Baseline, Weeks 8, 24 and 52 (EOT)
Percentage Change From Baseline in Type I Collagen C-Telopeptides at Weeks 8, 24 and 52 (EOT)
Percentage change from baseline in type I collagen C-telopeptides at Week 8, 24 and 52 (EOT) was reported.
Time frame: Baseline, Weeks 8, 24 and 52 (EOT)
Percentage Change From Baseline in Type I Collagen N-Telopeptides at Weeks 8, 24 and 52 (EOT)
Percentage change from baseline in type I collagen N-telopeptides at Week 8, 24 and 52 (EOT) was reported.
Time frame: Baseline, Weeks 8, 24 and 52 (EOT)