SFEBES2025 Oral Communications Bone and Calcium (6 abstracts)
Sustained improvement in renal function with palopegteriparatide in adults with chronic hypoparathyroidism: 2-year results from the phase 3 pathway trial
Neil Gittoes 1 , Peter Schwarz 2 , Lars Rejnmark 3 , Elvira Gosmanova 4 , Aliya Khan 5 , Noriko Makita 6 , Yasuo Imanishi 7 , Yasuhiro Takeuchi 8,9 , Stuart Sprague 10 , Dolores Shoback 11 , Lynn Kohlmeier 12 , Mishaela Rubin 13 , Andrea Palermo 14 , Claudia Gagnon 15 , Elena Tsourdi 16 , Carol Zhao 17 , Michael Makara 17 , Michael Ominsky 17 , Bryant Lai 17 , Jenny Ukena 17 , Christopher Sibley 17 & Aimee Shu 17
1Centre for Endocrinology, Diabetes and Metabolism, University of Birmingham and Queen Elizabeth Hospital, Birmingham, United Kingdom. 2Rigshpospitalet, Copenhagen, Denmark. 3Aarhus University Hospital, Aarhus, Denmark. 4Albany Medical College, Albany, USA. 5McMaster University, Hamilton, Canada. 6University of Tokyo Graduate School of Medicine, Tokyo, Japan. 7Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan. 8Toranomon Hospital, Tokyo, Japan. 9Japan and Okinaka Memorial Institute for Medical Research, Tokyo, Japan. 10NorthShore University Health System-University of Chicago Pritzker School of Medicine, Chicago, USA. 11University of California, San Francisco and VA Medical Center, San Francisco, USA. 12Endocrinology and Spokane Osteoporosis, Spokane, USA. 13Columbia University, New York, USA. 14Fondazione Policlinico Campus Bio-medico and Unit of Endocrinology and Diabetes, Campus Bio-medico University, Rome, Italy. 15CHU de Quebec-Universite Laval Reserach Centre and Department of Medicine, Quebec City, Canada. 16Technische Universitat Dresden Medical Center, Dresden, Germany. 17Ascendis Pharma Inc, Palo Alto, USA
Individuals with chronic hypoparathyroidism managed with conventional therapy (active vitamin D and calcium) are at increased risk for renal complications and declines in renal function. In clinical trials, palopegteriparatide treatment enabled independence from conventional therapy (no active vitamin D and ≤600 mg/day elemental calcium) and maintained serum biochemistries within normal ranges. This post hoc analysis examines the impact of palopegteriparatide treatment on renal function in adults with chronic hypoparathyroidism through week 104 of PaTHway, a phase 3 trial with a randomized, double-blind, placebo-controlled 26-week period and ongoing 156-week open-label extension. Changes in renal function were assessed using estimated glomerular filtration rate (eGFR). At week 104, 93% (76/82) of participants remained in the trial. Of those, 82% had normal albumin-adjusted serum calcium levels (2.07-2.64 mmol/l), 97% were independent from conventional therapy, none required active vitamin D. Mean (SD) serum phosphate (1.1 (0.2) mmol/l) and albumin-adjusted calcium x phosphate product (2.5(0.4) mmol2/l2) were normal. At week 104, mean (SD) eGFR was 77.8 (14.8) mL/min/1.73m2. With palopegteriparatide treatment mean eGFR increased 8.9 (11.0) mL/min/1.73m2 (P<.0001) from baseline to week 52, which was sustained through week 104 with a mean (SD) change from baseline of 9.0 (10.3) mL/min/1.73m2 (P<.0001). By week 104, 61% and 44% of participants had an increase in eGFR of ≥5 mL/min/1.73m2 and ≥10 mL/min/1.73m2, respectively. Palopegteriparatide treatment normalized mean 24-hour urine calcium within 26 weeks, maintaining levels below 6.2 mmol/day through week 104 (4.0 (2.3) mmol/day). No cases of nephrolithiasis were reported with palopegteriparatide. Most TEAEs were mild or moderate; no new safety signals reported. These findings demonstrate the sustained renal safety of palopegteriparatide and suggest that PTH replacement therapy with palopegteriparatide and independence from conventional therapy may not only preserve but improve renal function in adults with chronic hypoparathyroidism.
Volume 109
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Endocrine Abstracts
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