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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
13/01/2025
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
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
Secondary ID [1] 313602 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone health 336147 0
Condition category
Condition code
Alternative and Complementary Medicine 332695 332695 0 0
Herbal remedies
Musculoskeletal 332696 332696 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 330200 0
Treatment: Other
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)
Control group
Placebo

Outcomes
Primary outcome [1] 340222 0
Marker of bone formation
Timepoint [1] 340222 0
Days 0 (day before commencement of intervention) and 180 post-intervention commencement
Primary outcome [2] 340223 0
Marker of bone resorption
Timepoint [2] 340223 0
Days 0 (day before commencement of intervention) and 180 post-intervention commencement
Secondary outcome [1] 443381 0
Quality of life
Timepoint [1] 443381 0
Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
Secondary outcome [2] 443382 0
Quality of life
Timepoint [2] 443382 0
Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
Secondary outcome [3] 443383 0
Quality of life
Timepoint [3] 443383 0
Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
Secondary outcome [4] 443384 0
Energy
Timepoint [4] 443384 0
Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
Secondary outcome [5] 443385 0
Emotional wellbeing
Timepoint [5] 443385 0
Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
Secondary outcome [6] 443386 0
Social functioning
Timepoint [6] 443386 0
Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
Secondary outcome [7] 443387 0
Pain
Timepoint [7] 443387 0
Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
Secondary outcome [8] 443388 0
General health
Timepoint [8] 443388 0
Days 0 (day before commencement of intervention), 30, 60, 90, 120, 150, and 180 post-intervention commencement
Secondary outcome [9] 443745 0
Renal Function (safety outcome)
Timepoint [9] 443745 0
Days 0 (day before commencement of intervention) and 180 post-intervention commencement
Secondary outcome [10] 443747 0
Liver Function (safety outcome)
Timepoint [10] 443747 0
Days 0 (day before commencement of intervention) and 180 post-intervention commencement

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.
Minimum age
50 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque numbered containers
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)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
23/06/2025
Actual
Date of last data collection
Anticipated
22/12/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 318072 0
Commercial sector/Industry
Name [1] 318072 0
NuLiv Science USA, Inc
Country [1] 318072 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
Country
Australia
Secondary sponsor category [1] 320427 0
None
Name [1] 320427 0
Address [1] 320427 0
Country [1] 320427 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316721 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 316721 0
https://niim.com.au/research/niim-human-research-ethics-committee
Ethics committee country [1] 316721 0
Australia
Date submitted for ethics approval [1] 316721 0
28/10/2024
Approval date [1] 316721 0
19/12/2024
Ethics approval number [1] 316721 0
0148E_2024

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 Bone Alkaline Phosphatase (B-ALP) 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138786 0
Dr Adrian Lopresti
Address 138786 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 138786 0
Australia
Phone 138786 0
+61 08 94487376
Fax 138786 0
Email 138786 0
[email protected]
Contact person for public queries
Name 138787 0
Adrian Lopresti
Address 138787 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 138787 0
Australia
Phone 138787 0
+61 08 94487376
Fax 138787 0
Email 138787 0
[email protected]
Contact person for scientific queries
Name 138788 0
Adrian Lopresti
Address 138788 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 138788 0
Australia
Phone 138788 0
+61 08 94487376
Fax 138788 0
Email 138788 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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.