Searchable abstracts of presentations at key conferences in endocrinology
Endocrine Abstracts (2014) 35 OC6.4 | DOI: 10.1530/endoabs.35.OC6.4

ECE2014 Oral Communications Bone, calcium & vitamin D (5 abstracts)

The REPEAT Study: An open-label clinical trial evaluating the safety and efficacy of recombinant human parathyroid hormone, rhPTH(1–84), for the treatment of hypoparathyroidism in hungary

Peter Lakatos 1 , Laszlo Bajnok 2 , Hjalmar Lagast 3 & Zsuzsanna Valkusz 4


1Semmelweis University Medical School, Budapest, Hungary; 2University of Pécs, School of Medicine, Pécs, Hungary; 3NPS Pharmaceuticals, Inc., Bedminster, NJ, USA; 4University of Szeged and Albert Szent-Györgyi Medical and Pharmaceutical Center, Szeged, Hungary.


In hypoparathyroidism, inadequate levels of parathyroid hormone (PTH) result in hypocalcemia and often hyperphosphatemia. Large doses of calcium (Ca) and active vitamin D are typically used to manage symptoms, although these are often associated with complications and do not address the underlying PTH deficiency. In the phase III REPLACE trial, 24 weeks of treatment with rhPTH(1–84) was associated with maintained serum Ca without urine Ca excretion increases despite clinically meaningful reductions in oral Ca and active vitamin D in adults with hypoparathyroidism.

This open-label, 24-week study of subcutaneous rhPTH(1–84) was an extension of REPLACE. Patients received 50 μg/day rhPTH(1–84) (escalated to 75 and then to 100 μg/day, if needed, to reduce active vitamin D and oral Ca). The primary endpoint was defined as a ≥50% reduction from baseline in oral Ca and active vitamin D (or oral Ca ≤500 mg/day and calcitriol ≤0.25 μg/day or alfacalcidol ≤0.50 μg/day) and maintenance of serum Ca within normal limits.

Twenty-four patients [n=16 previously treated with rhPTH(1–84); n=8 rhPTH(1–84)-naive] enrolled (mean age, 52.7±10.9 years; 88% women; mean disease duration, 15.1±12.6 years). On average, 10.4 weeks elapsed between completion of REPLACE and REPEAT enrollment. At Week 24, 18/24 (75%) patients met the primary efficacy endpoint; 14/24 (58%) patients eliminated all oral Ca and active vitamin D. Treatment-emergent adverse events (TEAEs) were reported by 22/24 (92%) patients. The most common TEAEs were hypoesthesia (12/24 (50%)); muscle spasms and decreased vitamin D (both 6/24 (25%); unrelated); hypercalcemia (5/24 (21%)); fatigue, headache, and hypocalcemia (all 4/24 (17%); unrelated). No serious AEs occurred; no patients discontinued because of AEs.

rhPTH(1–84) 50, 75, or 100 μg/day was generally well tolerated. For the 16 patients who previously received rhPTH(1–84) in REPLACE, efficacy was sustained over long-term treatment.

Article tools

My recent searches

No recent searches.