ECE2016 Eposter Presentations Bone & Osteoporosis (40 abstracts)
Similarities in postsurgical vs nonsurgical patients with hypoparathyroidism: post hoc analysis from recombinant human parathyroid hormone (rhPTH[1-84], parathyroid hormone rDNA) REPLACE study
Maria Luisa Brandi 1 , John P Bilezikian 2 , Bart L Clarke 3 , William Fraser 4 , Alan Krasner 5 , Hjalmar Lagast 6 , Benjamin Li 6 , Michael Mannstadt 7 , Lars Rejnmark 8 , Dolores M Shoback 9 & Tamara J Vokes 10
1Endocrinology and Metabolic Diseases, University of Florence, Florence, Italy; 2Division of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York, USA; 3Mayo Clinic Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Rochester, Rochester, Minnesota, USA; 4Department of Medicine, Norwich Medical School, University of East Anglia, Norwich, UK; 5Shire Plc., Lexington, Massachusetts, USA; 6NPS Pharmaceuticals, Inc., Bedminster, New Jersey, USA; 7Endocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA; 8Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark; 9Endocrine Research Unit, SF Department of Veterans Affairs Medical Center, University of California, San Francisco, California, USA; 10Section of Endocrinology, University of Chicago Medicine, Chicago, Illinois, USA.
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 hypoparathyroidism were evaluated. Demographic and baseline characteristics were compared between groups with chi-square tests for categorical variables and one-way analysis of variance with effect for continuous variables. Responders were defined as patients whose need for conventional treatment with oral calcium and active vitamin D was reduced by ≥50% while maintaining serum calcium at 2.00–2.25 mmol/l.
Of 124 randomized patients, 89 (72%) had postsurgical and 35 (28%) had nonsurgical hypoparathyroidism. Interestingly per criteria in the 2015 ESE guidelines, ≥80% of patients within each subgroup were not well controlled pre-rhPTH(1-84) even after optimization with conventional treatment. Overall, there were more similarities than differences between the two groups. The only significant differences between groups were male gender (9/89 [10%] vs 17/35 [49%]; P<0.0001), age at onset (49.1 vs 42.9 years, P=0.014), and time since diagnosis (12.1 vs 17.5 years, P=0.008). At baseline, mean (S.D.) serum intact PTH levels were 0.79 (0.94) and 0.37 (0.48) pmol/l in the postsurgical and nonsurgical groups, respectively; healthy adult range is 1.48-7.63 pmol/l. In the postsurgical group, the 58% responder rate with rhPTH(1-84) (35/60) was significantly higher than the 3% rate with placebo (1/29; P<0.001). In the nonsurgical group, the 46% responder rate in the rhPTH(1-84) group (11/24) was numerically higher than the 0% placebo group rate (0/11; P=0.007).
This post hoc analysis did not suggest any differences in response to PTH(1-84) based on etiology of hypoparathyroidism.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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