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Effect of Surgery Versus Observation: Skeletal 5‐Year Outcomes in a Randomized Trial of Patients With Primary HPT (the SIPH Study)
Author(s) -
Lundstam Karolina,
Heck Ansgar,
Godang Kristin,
Mollerup Charlotte,
Baranowski Marek,
Pernow Ylva,
Aas Turid,
Hessman Ola,
Rosén Thord,
Nordenström Jörgen,
Jansson Svante,
Hellström Mikael,
Bollerslev Jens
Publication year - 2017
Publication title -
journal of bone and mineral research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.882
H-Index - 241
eISSN - 1523-4681
pISSN - 0884-0431
DOI - 10.1002/jbmr.3177
Subject(s) - medicine , bone mineral , randomized controlled trial , primary hyperparathyroidism , femoral neck , asymptomatic , parathyroidectomy , bone remodeling , urology , bone density , surgery , gastroenterology , osteoporosis , parathyroid hormone , calcium
Mild primary hyperparathyroidism (PHPT) is known to affect the skeleton, even though patients usually are asymptomatic. Treatment strategies have been widely discussed. However, long‐term randomized studies comparing parathyroidectomy to observation are lacking. The objective was to study the effect of parathyroidectomy (PTX) compared with observation (OBS) on bone mineral density (BMD) in g/cm 2 and T ‐scores and on biochemical markers of bone turnover (P1NP and CTX‐1) in a prospective randomized controlled study of patients with mild PHPT after 5 years of follow‐up. Of 191 patients with mild PHPT randomized to either PTX or OBS, 145 patients remained for analysis after 5 years (110 with validated DXA scans). A significant decrease in P1NP ( p < 0.001) and CTX‐1 ( p < 0.001) was found in the PTX group only. A significant positive treatment effect of surgery compared with observation on BMD (g/cm 2 ) was found for the lumbar spine (LS) ( p = 0.011), the femoral neck (FN) ( p < 0.001), the ultradistal radius (UDR) ( p = 0.042), and for the total body (TB) ( p < 0.001) but not for the radius 33% (Rad33), where BMD decreased significantly also in the PTX group ( p = 0.012). However, compared with baseline values, there was no significant BMD increase in the PTX group, except for the lumbar spine. In the OBS group, there was a significant decrease in BMD (g/cm 2 ) for all compartments (FN, p < 0.001; Rad33, p = 0.001; UDR, p = 0.006; TB, p < 0.001) with the exception of the LS, where BMD was stable. In conclusion, parathyroidectomy improves BMD and observation leads to a small but statistically significant decrease in BMD after 5 years. Thus, bone health appears to be a clinical concern with long‐term observation in patients with mild PHPT. © 2017 American Society for Bone and Mineral Research.