Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000940370
Ethics application status
Approved
Date submitted
23/06/2017
Date registered
30/06/2017
Date last updated
8/02/2021
Date data sharing statement initially provided
8/02/2021
Date results information initially provided
8/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Inosine Supplements on Markers of Bone Health
Scientific title
Effects of oral inosine supplements on bone turnover markers in healthy post-menopausal women
Secondary ID [1] 292270 0
Nil
Universal Trial Number (UTN)
U111111982020
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-menopausal bone health decline 303791 0
Condition category
Condition code
Musculoskeletal 303161 303161 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Inosine 500mg tablets (1 tablet in the morning, 1 tablet in the evening) for 6 months.
Adherence will be assessed by pill counts
Intervention code [1] 298447 0
Prevention
Comparator / control treatment
Placebo tablets (1 tablet in the morning, 1 tablet in the evening) consisting of lactose, microcrystalline cellulose, and magnesium stearate.
Adherence will be assessed by pill counts
Control group
Placebo

Outcomes
Primary outcome [1] 302530 0
1. Change in P1NP using serum samples
Timepoint [1] 302530 0
Measured at 6 weeks, 13 weeks, 19 weeks, 26 weeks
Primary outcome [2] 302531 0
2. Change in ßCTx using serum samples
Timepoint [2] 302531 0
Measured at 6 weeks, 13 weeks, 19 weeks, 26 weeks
Secondary outcome [1] 336316 0
Change in serum urate
Timepoint [1] 336316 0
Measured at 6 weeks, 13 weeks, 19 weeks, 26 weeks
Secondary outcome [2] 336317 0
Change in serum creatinine
Timepoint [2] 336317 0
Measured at 6 weeks, 13 weeks, 19 weeks, 26 weeks
Secondary outcome [3] 336318 0
Change in systolic blood pressure
Timepoint [3] 336318 0
Measured at 6 weeks, 13 weeks, 19 weeks, 26 weeks
Secondary outcome [4] 336319 0
Change in body mass index
Timepoint [4] 336319 0
Measured at 6 weeks, 13 weeks, 19 weeks, 26 weeks
Secondary outcome [5] 336320 0
All adverse events (as defined by the FDA)
Timepoint [5] 336320 0
Over 6 months
Secondary outcome [6] 336321 0
Change in grip strength using hand dynamometer
Timepoint [6] 336321 0
Measured at 6 weeks, 13 weeks, 19 weeks, 26 weeks
Secondary outcome [7] 336322 0
Change in lipid profile (LDL, HDL, TG) using a serum assay
Timepoint [7] 336322 0
Measured at 6 weeks, 13 weeks, 19 weeks, 26 weeks
Secondary outcome [8] 336323 0
Change in fasting serum glucose
Timepoint [8] 336323 0
Measured at 6 weeks, 13 weeks, 19 weeks, 26 weeks
Secondary outcome [9] 336324 0
Change in serum C-reactive protein
Timepoint [9] 336324 0
Measured at 6 weeks, 13 weeks, 19 weeks, 26 weeks
Secondary outcome [10] 336325 0
Change in fractional excretion of uric acid (FEUA) calculated from both serum and urine assays
Timepoint [10] 336325 0
Measured at 6 weeks, 13 weeks, 19 weeks, 26 weeks
Secondary outcome [11] 336417 0
Change in diastolic blood pressure
Timepoint [11] 336417 0
Measured at 6 weeks, 13 weeks, 19 weeks, 26 weeks
Secondary outcome [12] 336418 0
Serious adverse events (as defined by the FDA)
Timepoint [12] 336418 0
Over 6 months

Eligibility
Key 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
Minimum age
56 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/01/2018
Actual
17/04/2018
Date of last participant enrolment
Anticipated
Actual
12/04/2019
Date of last data collection
Anticipated
Actual
30/09/2019
Sample size
Target
120
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 9012 0
New Zealand
State/province [1] 9012 0

Funding & Sponsors
Funding source category [1] 296816 0
University
Name [1] 296816 0
University of Auckland
Country [1] 296816 0
New Zealand
Funding source category [2] 307804 0
Charities/Societies/Foundations
Name [2] 307804 0
Auckland Medical Research Foundation
Country [2] 307804 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85 Park Rd
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 295806 0
None
Name [1] 295806 0
Address [1] 295806 0
Country [1] 295806 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298052 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 298052 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 298052 0
New Zealand
Date submitted for ethics approval [1] 298052 0
23/06/2017
Approval date [1] 298052 0
19/07/2017
Ethics approval number [1] 298052 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75826 0
Prof Nicola Dalbeth
Address 75826 0
Department of Medicine
Faculty of Medical and Health Sciences
University of Auckland
85 Park Rd, Grafton, Auckland 1023
Country 75826 0
New Zealand
Phone 75826 0
+64 9 3737999
Fax 75826 0
+64 9 373 7677
Email 75826 0
n.dalbeth@auckland.ac.nz
Contact person for public queries
Name 75827 0
Bobby Mihov
Address 75827 0
Department of Medicine
Faculty of Medical and Health Sciences
University of Auckland
85 Park Rd, Grafton, Auckland 1023
Country 75827 0
New Zealand
Phone 75827 0
+64 9 9231747
Fax 75827 0
+64 9 373 7677
Email 75827 0
b.mihov@auckland.ac.nz
Contact person for scientific queries
Name 75828 0
Nicola Dalbeth
Address 75828 0
Department of Medicine
Faculty of Medical and Health Sciences
University of Auckland
85 Park Rd, Grafton, Auckland 1023
Country 75828 0
New Zealand
Phone 75828 0
+64 9 3737999
Fax 75828 0
+64 9 373 7677
Email 75828 0
n.dalbeth@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseElevated Urate Levels Do Not Alter Bone Turnover Markers: Randomized Controlled Trial of Inosine Supplementation in Postmenopausal Women.2021https://dx.doi.org/10.1002/art.41691
EmbaseEffects of elevated serum urate on cardiometabolic and kidney function markers in a randomised clinical trial of inosine supplementation.2022https://dx.doi.org/10.1038/s41598-022-17257-1
N.B. These documents automatically identified may not have been verified by the study sponsor.