Effect of Surgery Versus Observation: Skeletal 5‐Year Outcomes in a Randomized Trial of Patients With Primary HPT (the SIPH Study)

@article{Lundstam2017EffectOS,
  title={Effect of Surgery Versus Observation: Skeletal 5‐Year Outcomes in a Randomized Trial of Patients With Primary HPT (the SIPH Study)},
  author={Karolina Lundstam and Ansgar Heck and Kristin Godang and Charlotte L. Mollerup and Marek Baranowski and Ylva Pernow and Turid Aas and Ola Hessman and Thord Ros{\'e}n and J{\"o}rgen Nordenstr{\"o}m and Svante Jansson and Mikael Hellstr{\"o}m and Jens Bollerslev},
  journal={Journal of Bone and Mineral Research},
  year={2017},
  volume={32}
}
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/cm2 and T‐scores and on biochemical markers of bone turnover (P1NP and CTX‐1) in a prospective… 
Effects of Parathyroidectomy on Quality of Life: 10 Years of Data From a Prospective Randomized Controlled Trial on Primary Hyperparathyroidism (the SIPH‐Study)
TLDR
The results of this large and long‐term RCT indicate improvement in some of the mental domains of SF‐36 following PTX, and in the absence of declines in renal and skeletal parameters, it may be safe to observe patients with mild PHPT for a decade.
Efficacy of parathyroidectomy compared with active surveillance in patients with mild asymptomatic primary hyperparathyroidism: a systematic review and meta-analysis of randomized-controlled studies
TLDR
In patients with mild asymptomatic PHPT, PTx increases BMD and reduces serum calcium concentrations, and its superiority over active surveillance in terms of fracture risk, nephrolithiasis and QoL cannot be supported by current data.
Long-Term Skeletal Outcomes of Primary Hyperparathyroidism Patients After Treatment with Parathyroidectomy: A Systematic Review and Meta-Analysis.
TLDR
The existing RCTs do not provide sufficient or precise evidence that PTX-treatment affects the fracture risk of primary hyperparathyroidism patients, but offer data that subsets of patients who could potentially benefit from PTx-treatment can be identified.
Effectiveness of anti-osteoporotic treatment after successful parathyroidectomy for primary hyperparathyroidism: a randomized, double-blind, placebo-controlled trial
TLDR
Postoperative anti-osteoporotic treatment can positively influence regain of BMD mainly in the lumbar spine and should be considered in patients with preoperatively diagnosed osteoporosis or osteopenia.
The Impact of Observation Versus Parathyroidectomy on Bone Mineral Density and Fracture Risk Determined by FRAX Tool in Patients With Primary Hyperparathyroidism.
  • R. Khan, James C. Martin, G. Das
  • Medicine
    Journal of clinical densitometry : the official journal of the International Society for Clinical Densitometry
  • 2020
Identification of independent factors affecting bone mineral density after successful parathyroidectomy for symptomatic hyperparathyroidism
TLDR
This study suggests that patient characteristics were not associated with the > 10% BMD increase, however, the BMD values of the femur and lumbar spine were significantly increased in symptomatic PHPT patients after parathyroidectomy.
Prediction of bone mass changes after successful parathyroidectomy using biochemical markers of bone metabolism in primary hyperparathyroidism: is it clinically useful?
TLDR
PHPT patients presented a significant correlation between preoperative levels of turnover markers and BMD improvement 1 year after PTX, correlating these measurements with bone mineral density (BMD) changes.
Risk of Fracture Among Older Adults With Primary Hyperparathyroidism Receiving Parathyroidectomy vs Nonoperative Management.
TLDR
This longitudinal cohort study found that parathyroidectomy was associated with a lower risk of any fracture and hip fracture among older adults with PHPT, suggesting a clinically meaningful benefit of operative management in this population.
Primary hyperparathyroidism: recent advances
TLDR
Recommendations are made for more extensive renal and skeletal evaluation and broader criteria for PTX in PHPT, in addition to those based on age, serum calcium, bone densitometry and renal function.
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TLDR
Even though new vertebral fractures occurred only in the observation group, the frequency was not significantly different from the surgery group, and firm conclusions can be drawn about the long-term safety of observation, as opposed to surgery.
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It is feasible to conduct a randomized, controlled clinical trial of parathyroidectomy in patients with mild asymptomatic primary hyperparathyroidism, and measurable benefits of surgery on BMD, quality of life, and psychological function can be demonstrated.
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TLDR
In patients with mild asymptomatic primary hyperparathyroidism, successful PTx is followed by an improvement in BMD and quality of life, and most patients followed without surgery did not show evidence of progression.
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Evaluated evidence for the current recommendations concerning operation vs observation, repletion with vitamin D (VitD) and alternative medical management of patients with mild primary hyperparathyroidism found operation seems not to be superior to observation for cardiovascular risk factors.
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TLDR
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TLDR
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TLDR
Gender, age, more severe pre-operative bone disease, and insurance status were all predictors for greater BMD improvement following PTX, and the use of bisphosphonates, estrogens, vitamin D supplementation, or tobacco were not independently associated with post-operative B MD improvement.
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TLDR
Calcium and PTH levels were normalized after surgery, and biochemical markers of bone turnover decreased by 35%, followed by a significant increase in BMD in the spine and femoral neck compared with the observation group.
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TLDR
Parathyroidectomy led to normalization of biochemical indices and sustained increases in BMD, which raises questions regarding how long patients with PHPT should be followed up without intervention.
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