Not Yet RecruitingPhase 3ACTRN12614000049673

Nitrates for bone protection in chronic kidney disease

Nitrates as a potential therapeutic option for bone fragility in chronic kidney disease - a randomised, double blind placebo controlled trial


Sponsor

The University of Melbourne

Enrollment

60 participants

Start Date

Apr 1, 2014

Study Type

Interventional

Conditions

Summary

Studies have consistently shown that low trauma fractures are widely prevalent among patients with chronic kidney disease (CKD). However, the management of this condition remains controversial because the safety and efficacy of most currently available treatments for the prevention of fractures have not been adequately tested in patients with CKD. Further, many of these treatments are potentially toxic to kidneys and may also have deleterious effects in certain types renal bone disease. Therefore, there is a need for investigating new therapies for bone protection in CKD, using drugs that are safe and effective in patients with CKD. Recent evidence suggests that nitrates have all the attributes to be a potential candidate for bone protection in CKD. They have been shown to have bone protective properties in postmenopausal women, although not specifically in patients with CKD, and their safety in CKD, including in patients with advanced CKD, is well established. The current study is arandomised, placebo-controlled trail designed to assess the efficacy of isosorbide dinitrate, a commonly available oral nitrate preparation in Australia, versus placebo in the prevention of spinal bone loss in patients with moderately severe kidney disease (CKD stage 3 and 4).


Eligibility

Sex: Both males and femalesMin Age: 50 YearssMax Age: 90 Yearss

Inclusion Criteria2

  • Participants willl have both stage 3 or 4 CKD and either
  • osteopenia or osteoporosis

Exclusion Criteria6

  • Minimal trauma fractures
  • Uncorrected vitamin D deficiency (< 50 nmol/L)
  • PTH > 15 pmols/L
  • Metabolic bone diseases
  • Prednisolone > 5 mgs/d
  • Unexplained elevation of serum alkaline phosphatase

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Interventions

Isosorbide dinitrate 20 mg or matching placebo once daily for 12 months as an oral tablet. Adherence will be monitored by counting of drug tablet returned.

Isosorbide dinitrate 20 mg or matching placebo once daily for 12 months as an oral tablet. Adherence will be monitored by counting of drug tablet returned.


Locations(2)

Western Hospital - Footscray

VIC, Australia

Sunshine Hospital - St Albans

VIC, Australia

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