Plain English Summary
Background and study aims
The menopause happens when a woman stops having periods and is no longer able to get pregnant naturally. Symptoms can include hot flushes, low mood or anxiety, reduced sex drive and problems with memory and concentration. It can also increase the risk of developing osteoporosis, a condition where the bones become weaker and more likely to break. This study investigates whether a food supplement can alleviate the symptoms of the menopause and reduce the likelihood of developing osteoporosis.
Who can participate?
Women aged between 50-55 and going through the menopause.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are given the active food supplement. Those in group 2 are given a placebo (dummy pill). Markers that show whether the participant is at risk of developing osteoporosis are measured for all participats before treatment begins, 6 months after treatment and again after 12 months.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Farcoderm Srl, San Martino Siccomario (Italy)
When is the study starting and how long is it expected to run for?
April 2011 to May 2012
Who is funding the study?
Paladin Pharma S.p.A.
Who is the main contact?
Dr Nobile Vincenzo
vincenzo.nobile@farcoderm.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Nobile Vincenzo
ORCID ID
http://orcid.org/0000-0001-9147-302X
Contact details
Via Mons. Angelini
21
San Martino Siccomario
27028
Italy
0039 0382 25504
vincenzo.nobile@farcoderm.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SI.02.DS.L_2011/584+SI.02.DS.L_2011/585
Study information
Scientific title
Assessment of the efficacy of a food supplement in improving bone turnover markers and menopause-related symptoms in post-menopausal women: a double blind, randomized clinical study of efficacy and safety.
Acronym
Study hypothesis
The study is aimed to assess the efficacy of the product in modulating the bone turnover markers and in improving the menopause-related symptoms in post-menopausal women.
Ethics approval
Independent Ethical Committee for Non-Pharmacological Clinical trials’, 30/03/2011, ref: 2011/02).
Study design
Monocentric, randomized, parallel group, interventional study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Home
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Menopause and bone turnover
Intervention
Treatment allocation is randomized according to a computer generated restricted randomization list.
The active product was named “Integratore menopausa Lot. FH226” while the placebo product was named “Integratore menopausa Lot. FH314”. The active and the placebo products were in tablet form and identical in appearance.
Product efficacy in modulating bone turnover markers was evaluated in 60 subjects (30 subjects per treatment arm) before and after 6 and 12 months treatment. The following markers were measured: deoxypyridinoline (DPD), acid phosphatase (AP), osteocalcin (OC), and bone-specific alkaline phosphatase (BAP). Bone mineral density (BMD) was assessed in a sub-group (n=15) of subjects. Product efficacy on ameliorating menopausal symptomatology was assessed in 60 subjects (30 subjects per treatment arm) before and after 1 and 3 months treatment by means of a validated questionnaire.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
1. Urinary Deoxypyridinoline (DPD) measured by means of high-performance liquid cromatography (HPLC), at baseline, and then 6 months and 12 months after treatment
2. Serum Acid phosphatase (AP) measured by means of electrophoresis on agarose gel according to the optimized method by D.G.K.C. at 37°C, at baseline, and then 6 months and 12 months after treatment
3. Serum Osteocalcin (OC) measured by means of electrochemiluminescence technique (ECLIA), at baseline, and then 6 months and 12 months after treatment
4. Serum Bone-specific alkaline phosphatase (BAP) measured by means of colorimetric-enzymatic technique, at baseline, and then 6 months and 12 months after treatment
5. Menopause syndrome by means of Menopause Rating Scale, assessed at baseline, 1 month and 3 months after treatment
Secondary outcome measures
1. Bone mineral density (BMD), measured at baseline, and then 6 months and 12 months after treatment
2. Amelioration of depression associated to menopause
3. Amelioration of sleep
Overall trial start date
19/04/2011
Overall trial end date
19/05/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy female subjects; Age: between 50 and 55 years old
2. Caucasian ethnicity
3. Body mass index between 20 and 25
4. Slightly overweight (10-20% than ideal weight)
5. Menopause onset (date of last menstrual cycle) not longer than 1 year from the date of study entry
6. Case history characterized by menopausal syndrome psychological complaints (anxiety, emotional instability, depression), hot flush, localized fat and body fat percentage increase
7. No participation in similar trials
8. Absence of disease
9. Agreement not to make any changes to the normal everyday routine
10. Agreement not to use during the study products with activity similar such than the tested product
11. Agreement not to make any changes to eating habits
12. Subjects informed of the trial procedures who have signed an informed consent form
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
120
Participant exclusion criteria
1. Subjects not satisfying the inclusion criteria
2. Subjects under local or systemic pharmacological treatment
3. Subjects who do not have endometrial hyperplasia in their case history
4. Hormone replacement therapy
5. Metabolic syndrome
6. Depressive syndrome not menopause related
7. Subjects with food intolerances
Recruitment start date
19/04/2011
Recruitment end date
19/06/2011
Locations
Countries of recruitment
Italy
Trial participating centre
Farcoderm Srl
Via Mons. Angelini. 21
San Martino Siccomario
27028
Italy
Sponsor information
Organisation
Paladin Pharma S.p.A.
Sponsor details
Via Vincenzo Monti
12/A
Torino
10126
Italy
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Paladin Pharma S.p.A.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Data (all the study data) will be published in an appropriate scientific journal in the field of menopause. The manuscript is under drafting and is planned to be submitted to the identified scientific journal by May 2016.
Intention to publish date
31/05/2016
Participant level data
Not expected to be available
Results - basic reporting
Publication summary