Chronic hypoparathyroidism is a life-long and irreversible disease for which the chronic administration of rhPTH(1-84) is a potential treatment option. The group of participants 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 participants with hypoparathyroidism over a long-term duration.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 6
Timeframe: Baseline (402), Month 6
Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 12
Timeframe: Baseline (402), Month 12
Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 18
Timeframe: Baseline (402), Month 18
Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 24
Timeframe: Baseline (402), Month 24
Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 30
Timeframe: Baseline (402), Month 30
Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at Month 36
Timeframe: Baseline (402), Month 36
Change From Baseline (402) in Concentration of Albumin-corrected Serum Calcium (ACSC) at End of Treatment (EOT) (up to Month 36)
Timeframe: Baseline (402), EOT (up to Month 36)