Karolina Lundstam1, Ansgar Heck, Charlotte Mollerup, Kristin Godang, Marek Baranowski, Ylva Pernow, Jan Erik Varhaug, Ola Hessman, Thord Rosén, Jörgen Nordenström, Svante Jansson, Mikael Hellström, Jens Bollerslev. 1. Department of Radiology (K.L., M.H.), Institute of Clinical Sciences, The Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, 413 46 Gothenburg, Sweden; Section of Specialized Endocrinology (A.H., K.G., J.B.), Oslo University Hospital, and Faculty of Medicine, University of Oslo, 0372 Oslo, Norway; Clinic of Breast and Endocrine Surgery (C.M.), Center HOC, Copenhagen University Hospital, Rigshospitalet, 2100 Copenhagen, Denmark; St. Olavs Hospital (M.B.), 7030 Trondheim, Norway; Departments of Molecular Medicine and Surgery, and Endocrinology (Y.P.), Karolinska Institutet, Karolinska University Hospital, 171 77 Stockholm, Sweden; Department of Surgery (J.E.V.), Haukeland University Hospital, 5021 Bergen, Norway; Department of Surgical Sciences (O.H.), University of Uppsala, 751 85 Uppsala, Sweden; Department of Medicine (T.R.), Section of Endocrinology, Diabetes and Metabolism, Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden; Department of Molecular Medicine and Surgery (J.N.), Karolinska Institutet, 171 76 Stockholm, Sweden; Department of Surgery (S.J.), Institute of Clinical Sciences, The Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden.
Abstract
CONTEXT: Mild primary hyperparathyroidism (PHPT) is a common disease especially in middle-aged and elderly women. The diagnosis is frequently made incidentally and treatment strategies are widely discussed. OBJECTIVE: To study the effect of parathyroidectomy (PTX) compared with observation (OBS) on biochemistry, safety, bone mineral density (BMD), and new fractures. DESIGN: Prospective, randomized controlled study (SIPH study), with a 5-year follow-up. SETTING: The study was conducted at multicenter, tertiary referral centers. PATIENTS: Of 191 randomized patients with mild PHPT, biochemical data were available for 145 patients after 5 years, with a mean age at inclusion of 62.8 years (OBS group, 9 males) and 62.1 years (PTX group, 10 males). INTERVENTION: Parathyroidectomy vs observation. MAIN OUTCOME MEASURES: Biochemistry, BMD, and new radiographic vertebral fractures. RESULTS:Serum-calcium and PTH-levels normalized after surgery and did not deteriorate by observation. BMD Z-scores were normal at inclusion in the lumbar spine (LS) and femoral neck (FN). For LS, BMD Z-scores were stable for 5 years with observation, but decreased in FN (P < .02). After surgery, BMD Z-scores increased significantly in both compartments (P < .02 for both), with a highly significant treatment effect of surgery compared to observation (P < .001). During follow-up, five new clinically unrecognized vertebral fractures were found in 5 females, all in the OBS group (P = .058). CONCLUSION: Even though new vertebral fractures occurred only in the observation group, the frequency was not significantly different from the surgery group. Longer follow-up is needed before firm conclusions can be drawn about the long-term safety of observation, as opposed to surgery.
RCT Entities:
CONTEXT: Mild primary hyperparathyroidism (PHPT) is a common disease especially in middle-aged and elderly women. The diagnosis is frequently made incidentally and treatment strategies are widely discussed. OBJECTIVE: To study the effect of parathyroidectomy (PTX) compared with observation (OBS) on biochemistry, safety, bone mineral density (BMD), and new fractures. DESIGN: Prospective, randomized controlled study (SIPH study), with a 5-year follow-up. SETTING: The study was conducted at multicenter, tertiary referral centers. PATIENTS: Of 191 randomized patients with mild PHPT, biochemical data were available for 145 patients after 5 years, with a mean age at inclusion of 62.8 years (OBS group, 9 males) and 62.1 years (PTX group, 10 males). INTERVENTION: Parathyroidectomy vs observation. MAIN OUTCOME MEASURES: Biochemistry, BMD, and new radiographic vertebral fractures. RESULTS: Serum-calcium and PTH-levels normalized after surgery and did not deteriorate by observation. BMD Z-scores were normal at inclusion in the lumbar spine (LS) and femoral neck (FN). For LS, BMD Z-scores were stable for 5 years with observation, but decreased in FN (P < .02). After surgery, BMD Z-scores increased significantly in both compartments (P < .02 for both), with a highly significant treatment effect of surgery compared to observation (P < .001). During follow-up, five new clinically unrecognized vertebral fractures were found in 5 females, all in the OBS group (P = .058). CONCLUSION: Even though new vertebral fractures occurred only in the observation group, the frequency was not significantly different from the surgery group. Longer follow-up is needed before firm conclusions can be drawn about the long-term safety of observation, as opposed to surgery.
Authors: C Marcocci; M L Brandi; A Scillitani; S Corbetta; A Faggiano; L Gianotti; S Migliaccio; S Minisola Journal: J Endocrinol Invest Date: 2015-03-28 Impact factor: 4.256
Authors: N Singh Ospina; S Maraka; R Rodriguez-Gutierrez; A E Espinosa de Ycaza; S Jasim; M Gionfriddo; A Castaneda-Guarderas; J P Brito; A Al Nofal; P Erwin; R Wermers; V Montori Journal: Osteoporos Int Date: 2016-08-25 Impact factor: 4.507
Authors: Milan D Jovanovic; Vladan R Zivaljevic; Aleksandar D Diklic; Branislav R Rovcanin; Goran V Zoric; Ivan R Paunovic Journal: Eur Arch Otorhinolaryngol Date: 2016-09-12 Impact factor: 2.503