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Abstract: PO0407

A Randomized, Double-Blind, Placebo-Controlled Trial Assessing Efficacy of Standard and Low-Dose Hydrochlorothiazide Treatment for Prevention of Recurrent Calcareous Nephrolithiasis (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, Inselspital Universitatsspital Bern, Bern, BE, Switzerland
  • Fuster, Daniel G., Inselspital Universitatsspital Bern, Bern, BE, Switzerland

Group or Team Name

  • on behalf of the 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 with the purpose to assess the dose-response relationship for three different dosages of hydrochlorothiazide (placebo, 12.5mg, 25.0mg, 50.0mg) in kidney stone prevention. The primary outcome is incidence of stone recurrence (a composite of symptomatic or radiologic recurrence) at 3 years, a low-dose CT will be performed at the beginning and the end of the trial. Patients from 12 hospitals throughout Switzerland were included in the trial.

Results

NOSTONE received all necessary approvals by the end of February 2017. Recruitment started in Bern on the 9th of March 2017, all study sites are operative since June 30th 2017. As of October 31st 2019, the target number of 416 patients randomized in the trial was reached and therefore recruitment stopped (www.nostone.ch). 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.

Conclusion

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

Funding

  • Government Support - Non-U.S.