A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2021
• Main ID: NCT02910466
• Date of registration: 20/09/2016
• Prospective Registration: Yes
• Primary sponsor: Shire
• Public title: A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism
• Scientific title: A Phase 4, Open-Label, Single-Center Clinical Study of Extended Use of rhPTH(1-84) in Hypoparathyroidism
• Date of first enrolment: October 27, 2016
• Target sample size: 39
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02910466
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Study Director
• Affiliation: Shire

Key inclusion & exclusion criteria

Inclusion Criteria

- Participants that are currently or previously enrolled in the core study (AAAE0544
[NCT01199614]) and have maintained uninterrupted therapy with recombinant human
parathyroid hormone (rhPTH(1-84)) (transient interruptions of up to 1 month
continuously off treatment may be allowed).

- Signed and dated informed consent form (ICF).

- Adult men and women 18 to 85 years of age.

- History of hypoparathyroidism for at least 12 months prior to rhPTH(1-84) treatment,
defined by the requirement for supplemental calcium and/or active vitamin D to
maintain serum calcium along with an undetectable or insufficient Parathyroid hormone
(PTH) concentration.

- Able to perform daily subcutaneous (SC) self-injections of study medication (or have
designee perform injection).

- Willingness and ability to understand and comply with the protocol. Women must agree
to pregnancy testing and acceptable methods of contraception, as detailed in the
protocol.

Exclusion Criteria

- The participant is treated or has been treated with any investigational drug, aside
from rhPTH(1-84), within 30 days of consent.

- As assessed by the investigator, the participant has any safety or medical issues that
contraindicate participation in the study.

- The participant and/or the participant's parent(s) or legally-authorized
representative(s) are unable to understand the nature, scope, and possible
consequences of the study.

- The participant is unable to comply with the protocol, example, uncooperative with
protocol schedule, refusal to agree to all of the study procedures, inability to
return for evaluations, or is otherwise unlikely to complete the study, as determined
by the investigator or the medical monitor.

- The participant is pregnant or lactating.

- Participants who are at increased baseline risk for osteosarcoma such as participant
with Paget's disease of bone or unexplained new elevations of alkaline phosphatase,
participants with hereditary disorders predisposing to osteosarcoma or participants
with a prior history of external beam or implant radiation therapy involving the
skeleton.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Hypoparathyroidism

Hypoparathyroidism

Intervention(s)

Drug: rhPTH(1-84)

Primary Outcome(s)

Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at End of Treatment (EOT) (up to Month 36) [Time Frame: Baseline (402), EOT (up to Month 36)]

Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 24 [Time Frame: Baseline (402), Month 24]

Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 36 [Time Frame: Baseline (402), Month 36]

Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 6 [Time Frame: Baseline (402), Month 6]

Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 18 [Time Frame: Baseline (402), Month 18]

Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 12 [Time Frame: Baseline (402), Month 12]

Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 30 [Time Frame: Baseline (402), Month 30]

Secondary Outcome(s)

Change From Baseline (402) in Active Vitamin D Supplement Dose Based on Investigator-prescribed Data and Diary Data at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) [Time Frame: Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36)]

Change From Baseline (402) in Bone Architecture Evaluated Using Dual-energy X-ray Absorptiometry (DXA) for Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) [Time Frame: Baseline, At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36)]

Change From Baseline (402) in Concentration of Bone Turnover Marker for Bone Specific Alkaline Phosphatase and Tartrate-resistant Acid Phosphatase-5b at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) [Time Frame: Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36)]

Change From Baseline (402) in Concentration of Serum Phosphate Levels at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) [Time Frame: Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36)]

Change From Baseline (402) in Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Assessment at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) [Time Frame: Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36)]

Change From Baseline (402) in Health-related Quality-of-life Measured With 36-item Short Form Health (SF-36) Survey at Month 12, 24, 36, and EOT (up to Month 36) [Time Frame: Baseline (402), At Month 12, 24, 36, and EOT (up to Month 36)]

Change From Baseline (402) in Concentration of Bone Turnover Markers at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) [Time Frame: Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36)]

Percentage of Participants Who Achieved ACSC Concentrations Above, Below, or in the Range of 1.875 mmol/L (7.5 Milligram Per Deciliter [mg/dL]) to Upper Limit of Normal (ULN) at Month 6, 12, 18, 24, 30, 36 and EOT (up to Month 36) [Time Frame: At Month 6, 12, 18, 24, 30, 36 and EOT (up to Month 36)]

Change From Baseline (402) in Hospital Anxiety and Depression Scale (HADS) at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) [Time Frame: Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36)]

Mean Bone Histology (Biopsy) of Adjusted Apposition Rate and Cancellous Minimum Apposition Rate at Month 12, and EOT (up to Month 36) [Time Frame: At Month 12, and EOT (up to Month 36)]

Mean Bone Histology (Biopsy) of Cancellous Bone Volume, Cancellous Eroded Surface, Cancellous Mineral Surface, And Cancellous Osteoid Surface at Month 12, and EOT (up to Month 36) [Time Frame: At Month 12, and EOT (up to Month 36)]

Mean Bone Histology (Biopsy) of Cancellous Osteoid Thickness and Cortical Width at Month 12, and EOT (up to Month 36) [Time Frame: At Month 12, and EOT (up to Month 36)]

Change From Baseline (402) in Bone Architecture Evaluated Using Dual-energy X-ray Absorptiometry (DXA) for Total T-scores at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) [Time Frame: Baseline, At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36)]

Mean Bone Histology (Biopsy) of Bone Formation Rate at Month 12, and EOT (up to Month 36) [Time Frame: At Month 12, and EOT (up to Month 36)]

Change From Baseline (402) in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Total Score at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) [Time Frame: Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36)]

Change From Baseline (402) in Hypoparathyroidism Symptoms Diary (HPT-SD) at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) [Time Frame: Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36)]

Change From Baseline (402) in Bone Architecture Evaluated Using High-resolution Peripheral Quantitative Computerized Tomography (HRpQCT) for Total Area of Radius and Tibia at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) [Time Frame: Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36)]

Change From Baseline (402) in Calcium Supplement Doses and Elemental Calcium Based on Investigator-prescribed Data and Diary Data at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) [Time Frame: Baseline, At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36)]

Change From Baseline (402) in Urinary Calcium Excretion at Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36) [Time Frame: Baseline (402), At Month 6, 12, 18, 24, 30, 36, and EOT (up to Month 36)]

Secondary ID(s)

SHP634-402

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/07/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02910466