None listed
Conditions
Brief summary
A number of observational studies have indicated that urate has positive effects on bone. Inosine is a nutritional supplement (available as an over the counter supplement ) that increases serum urate levels. We plan a six month randomised, double-blind, placebo-controlled trial of 120 postmenopausal female participants. Participants will be randomised to one of two groups (60 participants per group): either placebo or inosine 1g daily (500mg morning, 500mg evening). The coprimary endpoints will be change in markers of bone health (P1NP and ßCTX). Key secondary endpoints will be measures of kidney function, blood pressure and other features of metabolic syndrome.
Interventions
Inosine 500mg tablets (1 tablet in the morning, 1 tablet in the evening) for 6 months.
Adherence will be assessed by pill counts
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
56 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
a. Age >55 years b. Post-menopausal c. Female d. eGFR >60ml/min e. Serum urate <0.42mmol/L f. Able to provide written informed consent and attend study visits
Exclusion criteria
a. Bone mineral density T score <-2.5 at the total hip, femoral neck or lumbar spine b. Previous fragility fracture of the hip or clinical spine fracture c. Current or past use of bisphosphonate therapy within 12 months, or any past zoledronate use d. Use of hormone replacement therapy within 12 months e. History of gout f. History of kidney stones g. History of diabetes mellitus h. Diuretic use i. Urine pH less than 5.0 (risk factor for uric acid urolithiasis) j. Current use of inosine as a nutritional supplement
Outcome results
None listed