MenopausePhase 2/3NCT00355953
Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women
A Phase 2/3 study testing Genistein in people with Menopause and Osteopenia, run by University of Messina.
Trial summary
The present research program is proposed deepening some pharmacological effects of the genistein therapy in order to individualize alternative treatments to the conventional hormonal replacement therapy useful to reduce the cardiovascular morbidity and mortality and the osteoporotic consequences in postmenopausal… Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Menopause, Osteopenia
- What is being tested?
- Genistein
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jun 2005
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one year of menopause
- No use of hormone replacement therapy
- Bone mineral density T-score at the femoral neck minor than one S.D.
Who cannot join
- Concomitant disease
- Smoke habit
About this study
The present research program is proposed deepening some pharmacological effects of the genistein therapy in order to individualize alternative treatments to the conventional hormonal replacement therapy useful to reduce the cardiovascular morbidity and mortality and the osteoporotic consequences in postmenopausal women.
Read the detailed description
Genistein is a phytoestrogen of the isoflavone family which has been shown to have beneficial effects on endothelial function and bone metabolism. On the basis of the so far obtained results, aim of our research was to investigate for a two years period the effects of genistein on cardiovascular risk factors, endothelial function and oxidative stress markers, bone metabolism and finally clarify pathophysiology mechanisms (by dosage of cytokines and endothelial markers) by which this molecule could interfere on atherosclerosis and bone mass loss progression.
Particularly, and in extreme synthesis the following parameters have been studied during the treatment:
- inflammation markers as fibrinogen
- lipid profile - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, lipoprotein(a)-
- endothelial function markers as VCAM-1 and ICAM-1
- oxidative stress by the evaluation of the F(2)-isoprostane
- cytokines as IL-6, OPG, RANK and RANKL
- bone mineral density, by DEXA, at lumbar spine and femoral neck
- Bone turnover markers as B-ALP, PYR, D-PYR
- PAP-test, transvaginal uterine ecography and mammography.
- Conditions
- Menopause, Osteopenia
- Being tested
- Genistein
- Keywords
- Post-Menopausal Women, Osteoporosis, Phytoestrogen, Genistein
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenisteinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy:
bone resorption/formation
bone mineral density
cardiovascular risk factors
Safety:
endometrial thickness
Secondary outcomes (5)
Efficacy:
hot flushes reduction
Safety:
mammography
vaginal cells maturation value
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startJan 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Investigators
- Francesco Squadrito, MD, Study director, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355953
- Sponsor's protocol ID
- 2002067398
- Status last verified
- Apr 2008
- First submitted
- 24 Jul 2006
- Last updated
- 22 Apr 2008
- Results posted
- No
Publications
Marini H, Minutoli L, Polito F, Bitto A, Altavilla D, Atteritano M, Gaudio A, Mazzaferro S, Frisina A, Frisina N, Lubrano C, Bonaiuto M, D'Anna R, Cannata ML, Corrado F, Adamo EB, Wilson S, Squadrito F. Effects of the phytoestrogen genistein on bone metabolism in osteopenic postmenopausal women: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):839-47. doi: 10.7326/0003-4819-146-12-200706190-00005.
PubMed 17577003
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00355953
- Acronym / sponsor ID
- 2002067398
- Conditions
- Menopause, Osteopenia
- Keywords
- Post-Menopausal Women, Osteoporosis, Phytoestrogen, Genistein
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- Jun 2005
- First posted
- 25 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present research program is proposed deepening some pharmacological effects of the genistein therapy in order to individualize alternative treatments to the conventional hormonal replacement therapy useful to reduce the cardiovascular morbidity and mortality and the osteoporotic consequences in postmenopausal women.
Detailed description
Genistein is a phytoestrogen of the isoflavone family which has been shown to have beneficial effects on endothelial function and bone metabolism. On the basis of the so far obtained results, aim of our research was to investigate for a two years period the effects of genistein on cardiovascular risk factors, endothelial function and oxidative stress markers, bone metabolism and finally clarify pathophysiology mechanisms (by dosage of cytokines and endothelial markers) by which this molecule could interfere on atherosclerosis and bone mass loss progression.
Particularly, and in extreme synthesis the following parameters have been studied during the treatment:
- inflammation markers as fibrinogen
- lipid profile - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, lipoprotein(a)-
- endothelial function markers as VCAM-1 and ICAM-1
- oxidative stress by the evaluation of the F(2)-isoprostane
- cytokines as IL-6, OPG, RANK and RANKL
- bone mineral density, by DEXA, at lumbar spine and femoral neck
- Bone turnover markers as B-ALP, PYR, D-PYR
- PAP-test, transvaginal uterine ecography and mammography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least one year of menopause
- No use of hormone replacement therapy
- Bone mineral density T-score at the femoral neck minor than one S.D.
Key exclusion criteria (2 listed)
- Concomitant disease
- Smoke habit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genistein | Drug | – |
Primary outcome
Efficacy:
bone resorption/formation
bone mineral density
cardiovascular risk factors
Safety:
endometrial thickness
5 secondary outcomes
Efficacy:
hot flushes reduction
Safety:
mammography
vaginal cells maturation value
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2008.
- Derived from this study: PubMed 17577003Marini H, Minutoli L, Polito F, Bitto A, Altavilla D, Atteritano M, Gaudio A, Mazzaferro S, Frisina A, Frisina N, Lubrano C, Bonaiuto M, D'Anna R, Cannata ML, Corrado F, Adamo EB, Wilson S, Squadrito F. Effects of the phytoestrogen genistein on bone metabolism in osteopenic postmenopausal women: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):839-47. doi: 10.7326/0003-4819-146-12-200706190-00005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Squadrito, MD study director
University of Messina
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Genistein in people with Menopause and Osteopenia, run by University of Messina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy:. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00355953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2008.