ECE2017 Eposter Presentations: Calcium and Bone Calcium & Vitamin D metabolism (65 abstracts)
Chronic hypoparathyroidism disease profile from 492 patients in the PARADIGHM™ natural history global registry
Bart L Clarke 1 , Steven Ing 2 , Aliya Khan 3 , Michael Mannstadt 4 , Michael McDermott 5 , Rebecca Piccolo 6 , Michael H. Shanik 7 , Tamara J Vokes 8 & John Germak 9
1Mayo Clinic, Rochester, MN, USA; 2Ohio State University Wexner Medical Center, Columbus, OH, USA; 3McMaster University, Ontario, Canada; 4Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; 5University of Colorado Hospital, Aurora, CO, USA; 6Shire Human Genetic Therapies, Inc., Lexington, MA, USA; 7Endocrine Associates of Long Island, PC, Smithtown, NY, USA; 8University of Chicago Medicine, Chicago, IL, USA; 9Shire International GmbH, Zug, Switzerland.
PARADIGHM™ is a global registry (NCT01922440) of patients diagnosed with hypoparathyroidism (HPT) ≥6 months regardless of aetiology and management. Routine medical care data were entered using electronic case report forms; the 36-item Short Form Health Survey was completed by patients. Baseline-recorded data are reported for 492 patients enrolled as of 1 December 2016 from 41 centres. At baseline, 78% were women, mean (S.D.) age was 49 (17) years, and mean (S.D.) BMI was 29.8 (8.6) kg/m2. Medical histories included mood disorder (29%), arthritis (16%), kidney stones (11%), fractures (8%), chronic renal disease (6%), and hypercalciuria (3%). 93% of patients had baseline symptom data (for the previous 6 months), all reported ≥1 symptom; the most common were fatigue (40%), paraesthesia (30%), muscle twitching (24%), anxiety (20%), brain fog (17%), muscle weakness (17%), back pain (16%), and headache (16%). HPT management included oral calcium in 91% (calcium carbonate, 59%) and active vitamin D in 84% (calcitriol, 94%) of patients; 7% received recombinant PTH (1–84) in a clinical trial. 62% were taking ≥1 concomitant medication (45% thyroid hormone, 4% hydrochlorothiazide, 1% psycholeptics, <1% magnesium supplements). Key laboratory mean (S.D.) values were PTH 1.5 (1.5) pmol/l, albumin-corrected total serum calcium 2.1 (0.3) mmol/l, phosphate 1.4 (0.3) mmol/l, magnesium 0.8 (0.1) mmol/l, and 24-hour urinary calcium 7.2 (4.6) mmol/day. Among 330 patients who had imaging, calcifications were reported in 40 patients (12%): kidney (n=12), brain (n=9), cardiovascular (n=7), and other sites (n=12). In the previous 12 months, 47% of patients had 2−3 doctor visits and 49% had ≥1 emergency room visit owing to HPT. Mean (S.D., range) SF-36v2 summary scores for physical and mental components were 45.6 (10.7; 11.2−64.2) and 48.4 (11.0; 11.9−70.3). These real-world data for 492 patients enrolled in the PARADIGHM™ registry provide valuable insight into disease variability, symptom burden, and HPT treatment approach.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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