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Trial registered on ANZCTR
Registration number
ACTRN12625000021471
Ethics application status
Approved
Date submitted
20/12/2024
Date registered
13/01/2025
Date last updated
15/06/2025
Date data sharing statement initially provided
13/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
The effects of supplementation with a phyto-blend (Osteosine) on makers of bone health and general wellbeing in post-menopausal women
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Scientific title
The effects of supplementation with a phyto-blend (Osteosine) on makers of bone health and general wellbeing in post-menopausal women: A randomised, double-blind, placebo-controlled study
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Secondary ID [1]
313602
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bone health
336147
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Condition category
Condition code
Alternative and Complementary Medicine
332695
332695
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0
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Herbal remedies
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Musculoskeletal
332696
332696
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0
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Normal musculoskeletal and cartilage development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Cuscuta chinensis and Cnidium monnieri extract (Osteosine) (1 capsule taken orally, once daily, after dinner with or without food, delivering 100mg a day for 180 days). Adherence to capsule intake will be measured by a count of capsules returned on day 180
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Intervention code [1]
330200
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Treatment: Other
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Comparator / control treatment
A matching placebo (containing psyllium husk) in terms of taste and appearance and containing all ingredients except the active ingredient (Cuscuta chinensis and Cnidium monnieri extract)
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Marker of bone formation
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Assessment method [1]
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Procollagen type 1 N-terminal Propeptide (PINP)
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Timepoint [1]
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Days 0 (day before commencement of intervention) and 180 post-intervention commencement
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Primary outcome [2]
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Marker of bone resorption
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Assessment method [2]
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Serum ß-isomerized C-terminal telopeptide (ß-CTX)
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Timepoint [2]
340223
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Days 0 (day before commencement of intervention) and 180 post-intervention commencement
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Secondary outcome [1]
443384
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Energy
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Assessment method [1]
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Short Form - 36 energy score
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Timepoint [1]
443384
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Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
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Secondary outcome [2]
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Renal Function (safety outcome)
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Assessment method [2]
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Serum Renal Function Test
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Timepoint [2]
443745
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Days 0 (day before commencement of intervention) and 180 post-intervention commencement
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Secondary outcome [3]
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Quality of life
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Assessment method [3]
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Short Form - 36 Role limitations due to physical health score
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Timepoint [3]
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Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
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Secondary outcome [4]
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General health
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Assessment method [4]
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Short Form - 36 general health score
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Timepoint [4]
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Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
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Secondary outcome [5]
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Quality of life
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Assessment method [5]
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Short Form - 36 Physical Functioning Score
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Timepoint [5]
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Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
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Secondary outcome [6]
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Pain
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Assessment method [6]
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Short Form - 36 pain score
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Timepoint [6]
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Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
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Secondary outcome [7]
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Emotional wellbeing
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Assessment method [7]
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Short Form - 36 emotional wellbeing score
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Timepoint [7]
443385
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Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
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Secondary outcome [8]
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Quality of life
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Assessment method [8]
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Short Form - 36 Role limitations due to emotional problems score
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Timepoint [8]
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Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
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Secondary outcome [9]
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Social functioning
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Assessment method [9]
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Short Form - 36 social functioning score
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Timepoint [9]
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Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
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Secondary outcome [10]
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Liver Function (safety outcome)
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Assessment method [10]
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Serum Liver Funtion Test
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Timepoint [10]
443747
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Days 0 (day before commencement of intervention) and 180 post-intervention commencement
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Eligibility
Key inclusion criteria
1. Women aged between 50 and 80 years
2. Postmenopausal women (no menses for at least 12 months)
3. Non-smoker
4. BMI between 18 and 35 kg/m2
5. No plan to commence new treatments over the study period.
6. Understand, willing and able to comply with all study procedures.
7. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
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Minimum age
50
Years
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Maximum age
80
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Diagnosis of osteoporosis
2. Diagnosed with a disease-causing secondary osteoporosis within the last year, such as primary hyperparathyroidism, chronic obstructive pulmonary disease, chronic kidney disease, inflammatory bowel disease, celiac disease, or diabetes.
3. Use of pharmaceutical medications including but not limited to corticosteroids, antiepileptic drugs and antiresorptive therapy, including systemic hormone replacement therapy, bisphosphonates, and strontium ranelate.
4. Commencement of, or change in medication, herbal or vitamin supplements within 4 weeks before starting the study
5. The intake of any supplements known to affect bone metabolism, including vitamin D and mineral supplements.
6. A recent history of fragility fractures, especially those requiring surgical intervention.
7. Planned major lifestyle change in the next 6 months.
8. Alcohol intake greater than 14 standard drinks per week
9. Current or 12-month history of illicit drug use
10. Any significant surgeries over the last year
11. Participation in any other clinical trial in the last month
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque numbered containers
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
3/02/2025
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Actual
1/04/2025
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Date of last participant enrolment
Anticipated
23/06/2025
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Actual
11/06/2025
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Date of last data collection
Anticipated
8/12/2025
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Actual
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Sample size
Target
60
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Accrual to date
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Final
62
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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NuLiv Science USA, Inc
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Address [1]
318072
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Clinical Research Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
320427
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None
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Name [1]
320427
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Address [1]
320427
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Country [1]
320427
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316721
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National Institute of Integrative Medicine Human Research Ethics Committee
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Ethics committee address [1]
316721
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https://niim.com.au/research/niim-human-research-ethics-committee
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Ethics committee country [1]
316721
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Australia
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Date submitted for ethics approval [1]
316721
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28/10/2024
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Approval date [1]
316721
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19/12/2024
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Ethics approval number [1]
316721
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0148E_2024
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Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 60 generally healthy post-menopausal women aged 50 to 80 years will be randomly assigned to receive a phyto-blend comprising Cuscuta chinensis and Cnidium monnieri (Osteosine), or a placebo for 180 days (6 months). Changes in blood markers of bone turnover comprising Procollagen type 1 N-terminal Propeptide (PINP) and ß-isomerized C-terminal telopeptide (ß-CTX) will be measured at the beginning and end of supplementation to examine the effects of supplementation on bone turnover. A self-report questionnaire will also be regularly administered to examine changes in quality of life.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Adrian Lopresti
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Address
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
138786
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Australia
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Phone
138786
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+61 08 94487376
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Fax
138786
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Email
138786
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[email protected]
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Contact person for public queries
Name
138787
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Adrian Lopresti
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Address
138787
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
138787
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Australia
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Phone
138787
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+61 08 94487376
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Fax
138787
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Email
138787
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[email protected]
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Contact person for scientific queries
Name
138788
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Adrian Lopresti
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Address
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
138788
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Australia
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Phone
138788
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+61 08 94487376
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Fax
138788
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Email
138788
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Case-by-case basis at the discretion of Primary Sponsor
Conditions for requesting access:
•
-
What individual participant data might be shared?
•
Individual participant data underlying published results
What types of analyses could be done with individual participant data?
•
for IPD meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
Beginning 3 months and ending 5 years following main results publication
To:
-
Where can requests to access individual participant data be made, or data be obtained directly?
•
Access subject to approvals by Principal Investigator (
[email protected]
)
Are there extra considerations when requesting access to individual participant data?
No
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
No additional documents have been identified.
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