Searchable abstracts of presentations at key conferences in endocrinology

ea0070aep212 | Bone and Calcium | ECE2020

Renal complications in patients with chronic hypoparathyroidism receiving conventional therapy: A systematic literature review

Gosmanova Elvira , Houillier Pascal , Bilezikian John , Marelli Claudio , Rejnmark Lars

Conventional therapy for chronic hypoparathyroidism is oral calcium and active vitamin D; despite treatment, chronic hypoparathyroidism may be associated with increased risk of renal complications. Without the effect of parathyroid hormone on renal tubular reabsorption, calcium-conserving and phosphaturic effects are lost, serum calcium levels are reduced and serum phosphate levels are increased. This may lead to hypercalciuria and hyperphosphataemia, which may be associated w...

ea0035p160 | Calcium and Vitamin D metabolism | ECE2014

PARADIGHM: a natural history registry for patients with chronic hypoparathyroidism

Bowlin Steven , Sadowski Tara , Vokes Tamara , Bilezikian John , Clarke Bart , Mannstadt Michael , Shoback Dolores , Lagast Hjalmar

Chronic hypoparathyroidism affects ~2.5/10 000 individuals in the European Union and is classified as a rare disorder. There is limited knowledge of the natural history and epidemiology of this disease. Publications frequently represent a single center’s experience and information across the population of patients with hypoparathyroidism is lacking and needed. To fill the gap, a voluntary global hypoparathyroidism patient registry (PARADIGHM) was initiated by NPS Pharmace...

ea0016p750 | Thyroid | ECE2008

Impact of Cinacalcet treatment on health related quality of life (HRQOL) in patients with primary hyperparathyroidism (PHPT) who have failed or in whom parathyroidectomy (PTX) is contraindicated

Chanson Philippe , Shoback Dolores , Lu John , Cheng Sunfa , Ren Lulu , Bilezikian John

Hypercalcemic complications of PHPT include renal, cardiovascular, gastrointestinal, neuromuscular and neuropsychiatric issues, all potentially impacting negatively on HRQOL. As control of the hypercalcemia associated with PHPT might improve HRQOL, the SF-36 and a 6-item scale on cognitive functioning (CF) were included in a phase 2, single-arm study evaluating the ability of cinacalcet to control serum calcium levels in 17 patients with intractable PHPT. Mean±S.E....

ea0056gp177 | Parathyroid | ECE2018

Maintenance of key biochemical parameters with recombinant human parathyroid hormone (1-84) in patients with hypoparathyroidism: an analysis of a long-term, open-label, single-centre study

Krasner Alan , Cusano Natalie E , Rubin Mishaela R , Piccolo Rebecca , Bilezikian John P

Hypoparathyroidism is a rare disorder characterised by hypocalcaemia and insufficient or undetectable parathyroid hormone (PTH). Recombinant human PTH, rhPTH(1-84), has been approved in the United States and Europe as an adjunctive treatment for adult patients with hypoparathyroidism. When hypoparathyroidism is established, long-term administration of rhPTH(1-84) is a treatment option. Thus, long-term safety and efficacy data for rhPTH(1-84) are needed. To this end, we evaluat...

ea0035oc6.5 | Bone, calcium & vitamin D | ECE2014

The effect of recombinant human parathyroid hormone, rhPTH(1–84), on vitamin D metabolism and phosphate homeostasis: Results from phase III 24-Week REPLACE and phase I clinical studies

Brandi Maria Luisa , Beckers Albert , Vokes Tamara , Mannstadt Michael , Bilezikian John , Clarke Bart , Lagast Hjalmar , Shoback Dolores

PTH promotes conversion of 25-hydroxyvitamin D (25[OH]D) to 1,25-dihydroxyvitamin D (1,25[OH]2D), thus stimulating intestinal calcium and phosphate absorption. Because of low PTH levels in hypoparathyroidism, patients are prescribed calcitriol. Patients are predisposed to hyperphosphatemia owing to loss of PTH-stimulated phosphate excretion by the kidneys. Effects of rhPTH(1–84) on vitamin D metabolism and serum phosphate were studied.In ...

ea0041ep129b | Bone & Osteoporosis | ECE2016

Similarities in postsurgical vs nonsurgical patients with hypoparathyroidism: post hoc analysis from recombinant human parathyroid hormone (rhPTH[1-84], parathyroid hormone rDNA) REPLACE study

Brandi Maria Luisa , Bilezikian John P , Clarke Bart L , Fraser William , Krasner Alan , Lagast Hjalmar , Li Benjamin , Mannstadt Michael , Rejnmark Lars , Shoback Dolores M , Vokes Tamara J

Hypoparathyroidism, a rare disorder characterized by absent or low levels of parathyroid hormone (PTH), often results from thyroid surgery. However, nonsurgical etiologies are present in >10% of patients. Data about this group of patients are limited.In this post hoc REPLACE (NCT00732615, EudraCT2008-005063-34) analysis, baseline characteristics and response to 50–100 μg/day rhPTH(1-84) in patients with postsurgical or nonsurgical ...

ea0037oc3.5 | Calcium, vitamin D and bone | ECE2015

Three-year safety and efficacy data for recombinant human parathyroid hormone, rhPTH(1-84), in the treatment of adults with hypoparathyroidism: the RACE study

Clarke Bart L , Mannstadt Michael , Vokes Tamara J , Rothman Jeffrey , Warren Mark L , Denham Douglas S , Levine Michael A , Lagast Hjalmar , Bilezikian John P , Shoback Dolores M

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 r...

ea0056oc3.4 | New insights in bone disorders | ECE2018

Renal function change in chronic hypoparathyroidism patients treated with recombinant human parathyroid hormone (1-84) (rhPTH[1-84]) and in a historical control cohort treated with standard therapy

Chen Kristina , Rubin Mishaela , Mu Fan , Swallow Elyse , Zhao Jing , Wang Jessie , Krasner Alan , Sherry Nicole , Signorovitch James , Ketteler Markus , Bilezikian John

Standard therapy (ST) for chronic hypoparathyroidism (HPT) includes calcium and active vitamin D supplementation, which can be associated with an increased risk of renal complications. This study compared renal function change, assessed by estimated glomerular filtration rate (eGFR) over 5 years between HPT patients receiving rhPTH1-84 as an adjunct to ST and a historical control cohort without rhPTH1-84. rhPTH1-84-treated HPT patients were selected from two single-arm, long-t...

ea0073aep104 | Calcium and Bone | ECE2021

Evaluation of bone quality by dxa-based bone strain index in primary hyperparathyroidism

Tabacco Gaia , Naciu Anda Mihaela , Messina Carmelo , Rinaudo Luca , Cesareo Roberto , Falcone Stefania , Manfrini Silvia , Napoli Nicola , Bilezikian John , Ulivieri Fabio Massimo , Palermo Andrea

BackgroudPrimary hyperparathyroidism (PHPT) is associated with impaired bone quality and increased fracture risk. Reliable tools for the evaluation of bone quality parameters are not yet clinically available. Bone Strain Index (BSI) is a new metric for bone strength based on Finite Element Analysis from lumbar spine and femoral neck dual X-ray absorptiometry images.AimTo assess the lumbar spine (LS), femoral ...

ea0063gp15 | Calcium and Bone 1 | ECE2019

Recombinant human parathyroid hormone 1–84 for the treatment of adults with chronic hypoparathyroidism: Six-year safety and efficacy results of the RACE study

Bilezikian John P , Bone Henry , Clarke Bart L , Denham Douglas , Germak John , Lee Hak-Myung , Levine Michael A , Mannstadt Michael , Peacock Munro , Rothman Jeffrey G , Sherry Nicole , Shoback Dolores M , Vokes Tamara J , Warren Mark L , Watts Nelson B

Background: RACE is an open-label study that assessed the long-term safety and efficacy of recombinant human parathyroid hormone 1–84 (rhPTH[1–84]) for the treatment of hypoparathyroidism in adults (ClinicalTrials.gov identifier NCT01297309). Here, we present 6-year safety and efficacy data.Methods: Patients initially received 25 or 50 μg of rhPTH(1–84) subcutaneously, once daily, with stepwise dose adjustments of 25 μg (up or do...