MENOPAUSE BONE DENSITY

Current Study – Enrol Now!

Menopause Bone Density Study

Prevention of Bone Loss During Early Menopause Study

 

Bone density study in post-menopausal women. Are you in post-menopause and interested in your bone density?

If it has been between 12 months and 6 years since your last menstrual period, you could help assess the effectiveness of a new pre- and probiotic for maintaining bone density after menopause.

Thank you for your interest in our study which is evaluating the effectiveness of a pre- and probiotic supplement (in capsule form) for maintaining bone density in post-menopausal women who currently have normal (in normal range) bone density.

Do not worry if you don’t currently know what your bone density is. As part of the screening for this study, you will have a DEXA scan (at no cost to you) which will measure your bone density.

We are looking for healthy female volunteers who are between 12 months and 6 years since the last menstrual period.

You can make a difference by helping to investigate a natural treatment alternative for helping prevent bone density loss following menopause.

 

How long is the study, and when does it start?

Your involvement in this study will be 12 months and you will be required to come into our clinic for five visits over the duration of the study (at the beginning and then every 3 months).

To make timings of these visits as convenient as possible for you, we are recruiting on a rolling basis which means that your start date is flexible.

 

Quick Facts Menopause Bone Density Study

  • Location – Newstead, Brisbane
  • Duration of study – 12 months
  • Number of clinic visits – up to 5
  • Blood samples – 3
  • Product – supplied supplement to be taken twice-daily for 12 months

More Information About This Study

About the supplement you'll help test...

The investigational product is a capsule-form of four strains of probiotics isolated from various foods, and two foods that are known as prebiotics (foods that feed our gut microbiome). Previous research has shown these products to have beneficial effects on maintaining bone mass in post-menopausal women. All clinical studies, to date, found the product to be safe for use with no serious adverse effects associated with its oral administration. This study aims to investigate the efficacy of these products in changing bone mineral density, menopausal symptoms, and the quality of life associated with this condition.

The probiotics in the supplement are Lactobacillus brevis, Lactobacillus plantarum, Leuconostoc mesenteroides, and Pichia kudriavzevii. The prebiotics in the supplement are oligofructose and dried ground blueberry powder.

As this study is placebo-controlled, you may or may not be allocated the active product. 50% of participants will be assigned the placebo which is maltodextrin (a harmless inactive substance typically used as an additive in food production). During the study period, neither you nor the study investigators will know which product you have been allocated.

Regardless of whether you are randomly allocated to either the active or placebo group, you will also be provided a Vitamin D supplement to take with the study product for the duration of the study.

Vitamin D is an important nutrient for maintaining bone density. Reduction in estrogen levels may reduce your Vitamin D levels or cause a problem with Vitamin D deficiency. Therefore, we are including Vitamin D (500IU) supplementation free as part of the study.

Why is this study being conducted...

Due to a reduction in estrogen, bone density can decline post-menopause. This can lead to a condition called osteoporosis. It is estimated that on average, women lose around 10% of their bone mass after menopause.

This study is being conducted to assess whether taking the probiotic/prebiotic supplement will help maintain bone density over a 12-month period. We are also assessing whether the product reduces post-menopausal symptoms (such as hot flushes, mood swings and insomnia).

What is required of participants...

As part of the screening process for the study, you will have a DEXA scan to check your current bone density. This scan is provided as part of the study and is at no cost to you. If you are within the normal range, you will be eligible to join the study. If your scan detects abnormally low bone density, you will be referred to our study doctor for a consultation (at no cost to you).

Once we have confirmed that you have normal bone density, you will be allocated to one of the treatment groups.
The study is a randomized clinical study with two treatment groups. Each group will involve approximately 150 participants (300 in total).
150 participants will receive prebiotic/probiotic capsules + Vitamin D
150 participants will receive control (placebo) capsules + Vitamin D
As well as taking the study product, you will be asked to attend interviews, either at the clinic or via telephone consultation, and complete several assessments over the 12 months of the study.

The assessments for this study are as follows:

In your home

  • Online Gastrointestinal Questionnaire (Weekly at weeks 1, 2, 3 and 4)
  • Fecal Sample – via in home kit (Baseline, 6 months and 12 months)

At RDC Clinic Newstead (free parking available at the door)

  • Blood Sample (Baseline, 6 months and 12 months)
  • Online Questionnaires (Baseline, 3, 6, 9 and 12 months)

Exact Radiology Newstead (free parking available at the door)

  • DEXA Scan (Baseline, 6 months and 12 months)
  • CT Scan (Baseline and 12 months)

 

You will be provided with your bone density results within 2 weeks of each assessment. At the conclusion of your participation in the study, you will also be provided with a summary of your menopause symptom questionnaire results.
Blood and fecal samples will be analysed after all participants of the trial have completed. In a large, long term study such as this one, this may be up to 2 years after you have completed your individual participation in the study. Therefore, your individual blood and fecal sample results will not be available to you.

Payment

Being part of the study, all health assessments are free and paid for by the study funds. You will also be renumerated ($600 in total) for your time and travel to participate in the study with payments for completed timepoints as follows:

  • 3 months: $100
  • 6 months: $150
  • 9 months: $100
  • 12 months: $250

 

If you would like to help research bone density after menopause, we’d love to hear from you. Please register your interest by answering the questionnaire and completing the form on this page. We’ll then get in touch to screen you for eligibility.

Check if you can take part. Participant requirements...
  • In early menopause (at least 1 year but a maximum of 6 years since your last menstruation)
  • Available throughout the 12 months study period and able to fulfill all details of the protocol; including DEXA scan (x3), CT scan (x2),
  • provide stool samples for analysis of gut microbiome (x3), have blood tests (x3)
  • No known bone density issues (we will arrange a DEXA scan for you as part of the screening process)
  • At least 6-months since the last intake of any hormone replacement therapy
  • Body Mass Index (BMI) between 18.5 and 32.5
  • No serious or unstable illness
Ethics approval and privacy, you're in safe hands...

This Clinical study has been approved by National Institute of Integrative Medicine Human Research Ethics Committee under Approval Number: 0089E-2021.

Trained Trial Co-ordinators will supervise your progress throughout the study. Any of your personal information collected during the study will be kept in the strictest confidence, and all data is de-identified prior to analysis.

No personal details are ever published.

About the location where you'll attend clinic appointments...

The RDC Clinic is located at 76 Doggett Street, Newstead, Brisbane. Our clinic is open from 6.30am to 6pm M-F and have Saturday appointments available from 6.30am.

We are walking distance from the Commercial Road Ferry Terminal & local buses, and a quick 10-minute walk from Bowen Hills train station.

We also have free onsite visitor parking available.

Exact Radiology is also located in Newstead (in the ‘Bunnings Complex’ at 142 Breakfast Creek Road) and has ample free visitor parking available.