ECE2015 Oral Communications Calcium, vitamin D and bone (5 abstracts)
Three-year safety and efficacy data for recombinant human parathyroid hormone, rhPTH(1-84), in the treatment of adults with hypoparathyroidism: the RACE study
Bart L Clarke 1 , Michael Mannstadt 2 , Tamara J Vokes 3 , Jeffrey Rothman 4 , Mark L Warren 5 , Douglas S Denham 6 , Michael A Levine 7 , Hjalmar Lagast 8 , John P Bilezikian 9 & Dolores M Shoback 10
1Mayo Clinic Division of Endocrinology, Diabetes, Metabolism, & Nutrition, Rochester, Minnesota, USA; 2Endocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA; 3Section of Endocrinology, University of Chicago Medicine, Chicago, Illinois, USA; 4Division of Endocrinology, Staten Island University Hospital, Staten Island, New York, USA; 5Endocrinology and Metabolism, Physicians East, PA, Greenville, North Carolina, USA; 6Clinical Trials of Texas, Inc., San Antonio, Texas, USA; 7Division of Endocrinology and Diabetes, Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA; 8NPS Pharmaceuticals, Inc., Bedminster, New Jersey, USA; 9Division of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York, USA; 10Endocrine Research Unit, SF Department of Veterans Affairs Medical Center, University of California, San Francisco, California, USA.
Hypoparathyroidism is a rare endocrine deficiency due to inadequate amounts of parathyroid hormone (PTH) and is characterised by hypocalcaemia and hyperphosphataemia. Current management regimens with large amounts of oral calcium and active vitamin D do not adequately control mineral homeostasis and can lead to complications in many patients. The phase III REPLACE and RELAY clinical trials established the efficacy and safety of once-daily s.c. injection of recombinant human PTH, rhPTH(1-84). Here we present 3-year data from RACE, the open-label extension of REPLACE and RELAY. Patients received 25 or 50 μg/day rhPTH(1-84) with up-titration to 50, 75, or 100 μg/day if active vitamin D and oral calcium could be further reduced and serum calcium level remained at or above optimised baseline. Of 49 patients enrolled at 12 US centres (mean age 48±10 years; 82% women; mean hypoparathyroidism duration 16±12 years), 38 (78%) completed 36 months of rhPTH(1-84) as of September 30, 2014. 50% of patients (18/36) met the efficacy endpoint (≧50% reduction in oral calcium (or ≤500 mg/day), ≧50% reduction in active vitamin D dose (or ≤0.25 μg/day), and albumin-corrected serum calcium ≧1.87 mmol/l). Mean calcium and calcitriol doses were 2194±1732 mg/day and 0.7±0.4 μg/day, respectively, at baseline, and fell to 803±1259 mg/day (–54%±80%) and 0.2±0.3 μg/day (−71%±39%), respectively, at month 36. Albumin-corrected serum calcium levels were maintained (2.1±0.2 mmol/l at both baseline and month 36). Serum phosphorus levels were uniformly lower than baseline (1.56±0.19 mmol/l): mean change was −0.22±0.29 mmol/l at month 36. Adverse events (AEs) were reported by 48 (98%) patients; most common AEs were hypocalcemia (35%), muscle spasms (29%), and nausea (27%). Serious AEs occurred in 9 (18%) patients; none were considered to be treatment related. This extension trial confirms the efficacy and safety of rhPTH(1-84) for an extended 3-year period.
Volume 37
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Endocrine Abstracts
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