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Abstract: PO0599

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Assessing Efficacy of Standard and Low-Dose Hydrochlorothiazide in Recurrent Calcareous Nephrolithiasis Prevention: The NOSTONE Trial

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Dhayat, Nasser, Inselspital Universitatsspital Bern, Bern, BE, Switzerland
  • Bonny, Olivier, Centre Hospitalier Universitaire Vaudois, Lausanne, VD, Switzerland
  • Roth, Beat, Centre Hospitalier Universitaire Vaudois, Lausanne, VD, Switzerland
  • Cereghetti, Grazia Maria, Universitat Bern, Bern, Bern, Switzerland
  • Fuster, Daniel G., Inselspital Universitatsspital Bern, Bern, BE, Switzerland

Group or Team Name

  • NOSTONE investigators
Background

Nephrolithiasis is a global healthcare problem with a current lifetime risk of up to 18.8 % in men and 9.4 % in women. Without specific treatment, 5- and 20-year recurrence rates are 40 % and 75 %, respectively. Given the high cost of medical treatments and surgical interventions as well as the morbidity related to symptomatic stone disease, medical prophylaxis for stone recurrence is an attractive approach.
Efficacy of thiazides for kidney stone prevention was tested in 11 trials in the past. However, all these trials had major methodological deficiencies. Nowadays, thiazides are widely used in the treatment of recurrent nephrolithiasis and arterial hypertension, but at significantly lower doses. In the case of recurrent nephrolithiasis, however, this practice is not supported by randomized evidence. Thus, evidence for benefits and harms of thiazides in the prevention of kidney stones remains unclear.

Methods

NOSTONE is a multicenter, randomized, placebo-controlled, double-blind, parallel-group trial aiming to assess the dose-response relationship of three different dosages of hydrochlorothiazide (12.5mg, 25.0mg, 50.0mg) compared to placebo in the kidney stone prevention. The primary outcome incidence of stone recurrence at 3 years is a composite of symptomatic and radiologic recurrence (comparison of basal and end-of-study low-dose CT). The study included patients from 12 hospitals throughout Switzerland.

Results

The study was approved by all competent authorities by the end of February 2017. Recruitment started in Bern on March 9th 2017. All study sites are operative since June 30th 2017. The target number of 416 patients randomized in the trial was reached October 31st 2019 and recruitment stopped. In March 2020 the first patient randomized in the trial completed the treatment phase. All patients are expected to reach end of treatment by the end of August 2021 (www.nostone.ch).

Conclusion

The NOSTONE study will provide physicians with crucial information for the treatment of kidney stones. The impact of the results of this study will affect many patients currently under treatment with hydrochlorothiazide for the prevention of recurrent nephrolithiasis.

Funding

  • Government Support – Non-U.S.