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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000049673

Acronym

NITRACKD

Enrollment

Registered

2014-01-17

Start date

2014-04-01

Completion date

2015-10-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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).

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

50 Years to 90 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results