SFEBES2026 Emerging Researcher and Plenary Orals Clinical Endocrinology Journal Foundation Best Abstract (Clinical) (1 abstracts)
Improved Skeletal Dynamics in Adults Treated with Palopegteriparatide for Chronic Hypoparathyroidism: 214-Week Results from the Phase 2 PaTH Forward Trial
Jeremy Turner 1 , Mishaela Rubin 2 , Aliya Khan 3 , Peter Schwarz 4 , Andrea Palermo 5 , Elena Tsourdi 6 , Filomena Cetani 7 , Lynn Kohlmeier 8 , Rajesh Jain 9 , Bart Clarke 10 , Carol Zhao 11 , Michael Ominsky 11 , Bryant Lai 11 , Jenny Ukena 11 , Christopher Sibley 11 & Lars Rejnmark 12
1Norfolk and Norwich University Hospital, Norwich, United Kingdom; 2Columbia University, New York, USA; 3McMaster University, Hamilton, Canada; 4Rigshospitalet, Copenhagen, Denmark; 5Unit of Metabolic Bone and Thyroid Disorders, Fondazione Policlinico Campus Bio-medico, Rome, Italy; 6Department of Medicine III and 6Center for Healthy Aging, Technische Universität Dresden, Dresden, Germany; 7Department of Clinical and Experimental Medicine, Endocrine Unit, University of Pisa, Pisa, Italy; 8Endocrinology and Spokane Osteoporosis, Spokane, USA; 9University of Chicago, Chicago, USA; 10Mayo Clinic, Rochester, USA; 11Ascendis Pharma Inc, Palo Alto, USA; 12Aarhus University Hospital, Aarhus N, Denmark
Background: Hypoparathyroidism is associated with low rates of bone remodeling and increased bone mineral density (BMD) due to insufficient levels of parathyroid hormone (PTH). Palopegteriparatide (TransCon PTH), a prodrug of PTH (1-34) administered once daily, is designed to provide active PTH within the physiological range for 24 hours/day in adults with chronic hypoparathyroidism. Palopegteriparatide has received regulatory approval in the US, EU, UK and several other countries. This analysis investigated skeletal endpoints through week 214 of the PaTH Forward trial.
Methods: PaTH Forward was a phase 2, randomized, double-blind placebo-controlled 4-week trial followed by an open-label extension though week 266. Serum bone turnover markers procollagen type 1 N-terminal propeptide (P1NP) and C-terminal telopeptide of type 1 collagen (CTx) and BMD measured by DXA at the lumbar spine, total hip, femoral neck, and 1/3 distal radius were assessed.
Results: Of the 95% (n = 56) of participants who continued to receive palopegteriparatide treatment through week 214, 93% were independent from conventional therapy (≤600 mg/day elemental calcium and no active vitamin D) and 98% had albumin-adjusted serum calcium levels in the normal range (8.3-10.6 mg/dl). Mean CTx and P1NP were in the low end of normal at baseline, and increased with palopegteriparatide treatment, peaking at weeks 12 and 26, respectively. Thereafter, mean CTx and P1NP declined and remained stable and above baseline levels through week 214. The elevated baseline mean BMD Z-scores trended towards age- and sex-matched norms at the lumbar spine, femoral neck, and total hip and largely stabilized after 26 weeks of treatment, remaining above zero through week 214. No new safety signals were identified.
Conclusions: In adults with chronic hypoparathyroidism, continued treatment with palopegteriparatide through week 214 of PaTH Forward showed sustained skeletal remodeling with trends toward a new skeletal steady state closer to age-appropriate norms.
Volume 117
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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