Clinical Trial: Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 4, Open-Label, Single-Center Clinical Study of Extended Use of rhPTH(1-84) in Hypoparathyroidism
Brief Summary: Chronic hypoparathyroidism is a life-long disease for which the chronic administration of rhPTH(1-84) is a potential treatment option. The group of subjects in the AAAE0544 core study has been taking rhPTH(1-84) for the treatment of hypoparathyroidism for up to 11 years. This study is designed to extend this experience and gain knowledge about how safe and effective rhPTH(1-84) is in patients with hypoparathyroidism over a long-term duration.
Detailed Summary:
Sponsor: Shire
Current Primary Outcome: To evaluate albumin-corrected serum calcium while on rhPTH(1-84) treatment [ Time Frame: Baseline to 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To evaluate urinary calcium excretion while on rhPTH(1-84) treatment [ Time Frame: Baseline to 24 months ]
- To evaluate serum phosphate while on rhPTH(1-84) treatment [ Time Frame: Baseline to 24 months ]
- To evaluate calcium and active vitamin D supplement doses while on rhPTH(1-84) treatment as measured by serum chemistry panel [ Time Frame: Baseline to 24 months ]
- Participant disease- related symptoms as measured by Hypoparathyroidism (HPT) multi-symptom diary (patient reported symptom assessment ) [ Time Frame: Baseline to 24 months ]
- Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) patient reported assessment of cognitive function [ Time Frame: Baseline to 24 months ]
- Participant health-related quality-of-life measured with 36-item Short Form Health Survey (SF-36) [ Time Frame: Baseline to 24 months ]
- Skeletal actions of rhPTH(1-84) as measured by bone turnover (markers) [ Time Frame: Baseline to 24 months ]
- Skeletal actions of rhPTH(1-84) as measured by bone architecture [ Time Frame: Baseline to 24 months ]
- Skeletal actions of rhPTH(1-84) on bone histology measured by bone biopsy [ Time Frame: Baseline to 24 months ]
Original Secondary Outcome:
- To evaluate urinary calcium excretion while on rhPTH(1-84) treatment [ Time Frame: Baseline to 24 months ]
- To evaluate serum phosphate while on rhPTH(1-84) treatment [ Time Frame: Baseline to 24 months ]
- To evaluate calcium and active vitamin D supplement doses while on rhPTH(1-84) treatment as measured by serum chemistry panel [ Time Frame: Baseline to 24 months ]
- Particpant disease- related symptoms as measured by HPT multi-symptom diary (patient reported symptom assessment ) [ Time Frame: Baseline to 24 months ]
- FACT-Cog patient reported assessment of cognitive function [ Time Frame: Baseline to 24 months ]
- Particpant health-related quality-of-life measured with SF-36 survey [ Time Frame: Baseline to 24 months ]
- Skeletal actions of rhPTH(1-84) as measured by bone turnover (markers) [ Time Frame: Baseline to 24 months ]
- Skeletal actions of rhPTH(1-84) as measured by bone architecture [ Time Frame: Baseline to 24 months ]
- Skeletal actions of rhPTH(1-84) on bone histology measured by bone biopsy [ Time Frame: Baseline to 24 months ]
Information By: Shire
Dates:
Date Received: September 20, 2016
Date Started: October 2016
Date Completion: April 2019
Last Updated: October 24, 2016
Last Verified: October 2016