MenopauseNCT00626769
Third Year Evaluation on Genistein Efficacy and Safety
An observational study of Menopause and Osteopenia, run by University of Messina.
Trial summary
BACKGROUND: Recent evidences showed that the phytoestrogen genistein positively affects bone metabolism with no clinically significant adverse effects in a cohort of osteopenic, postmenopausal women. Read more about this study
- Who is it for?
- Ages 49 to 67 years, women only
- Conditions the study is for
- Menopause, Osteopenia
- What is being tested?
- aglycone genistein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Sep 2006
- Phase
- Observational
- 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 49 to 67 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal women (age 49-67 yrs)
Who may be able to join
- Good general health
- Have not had a menstrual period in the preceding year
- Had not undergone surgically induced menopause
- Had a follicle-stimulating hormone level > 50 IU/liter and a serum 17 beta-estradiol level ≤ 100 pmol/liter
- Established osteopenia (-1<T-score<-2.5 SD)
Who cannot join
- Clinical or laboratory evidence of confounding systemic diseases, such as cardiovascular, hepatic, or renal disorders
- Coagulopathy, use of oral or transdermal estrogen, progestin, androgen or other steroids
- Biphosphonates, cholesterol-lowering therapy or cardiovascular medications in the preceding six months
- Smoking habit of more than two cigarettes per day
- Previous treatment with any drug that could affect the skeleton in the preceding year
- A family history of estrogen-dependent cancer
- BMD at femoral neck > 0.795 g/cm2; this BMD value corresponds to a T score of -1 standard deviation
About this study
Official title: Safety Profile and Bone Efficacy of the Phytoestrogen Genistein in a Cohort of Osteopenic, Postmenopausal Women After Three Years of Treatment: a Follow-up Study
BACKGROUND: Recent evidences showed that the phytoestrogen genistein positively affects bone metabolism with no clinically significant adverse effects in a cohort of osteopenic, postmenopausal women. However, there is still a knowledge gap regarding the long-term safety of genistein on the breast, the uterus, the thyroid gland and its efficacy in postmenopausal women.
OBJECTIVE: To assess the safety profile of genistein on mammary and thyroid glands and endometrium and cardiovascular apparatus and its effects on bone metabolism after a 3-year therapy with pure, standardized genistein (54 mg/day).
Read the detailed description
DESIGN: The parent study was a randomized, double-blind, placebo-controlled trial involving 389 osteopenic, postmenopausal women for 24 months. After the 24-month visit, a sub-population (138 patients) accepted to continue the intervention until 36 months, thus generating a follow-up study.
SETTING: 3 Italian university medical centers. INTERVENTIONS: Participants received 54 mg of genistein, daily, (n=71) or placebo (n=67). Both intervention and placebo contained calcium and vitamin D3. All patients also received dietary instruction in an isocaloric fat-reduced diet.
MEASUREMENTS: Mammographic breast density at baseline and after 24 and 36 months was assessed by visual classification scale and by digitized quantification. BRCA1 and BRCA2 molecular message, sister chromatid exchanges and endometrial thickness were also evaluated at the same time points. Measurements of lumbar spine and femoral neck BMD and QUS t-score were assayed in our patients. Secondary outcomes were serum levels of B-ALP, IGF-I, sRANKL, osteoprotegerin and urinary excretion of CTX, pyridinoline and deoxypyridinoline. Furthermore insulin resistance (HOMA-IR), glucose levels, homocysteine and hot flushes were also evaluated. In addition for thyroid safety TSH, fT3, fT4, thyroid autoantibodies, and mRNA for thyroid and retinoid receptors were evaluated.
- Conditions
- Menopause, Osteopenia
- Being tested
- aglycone genistein, placebo
- Keywords
- Genistein, Bone mineral density, digital mammography, safety
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aglycone genisteinDietary supplement
Also called Genivis, Fosteum
2 capsules per day containing 27 mg of aglycone genistein, calcium carbonate (500 mg) and vitamin D (400 IU), for a 3-year period.
placeboDietary supplement
2 capsules per day containing calcium carbonate (500 mg) and vitamin D (400 IU), for a 3-year period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Postmenopausal women with established osteopenia receiving aglycone genistein 54 mg/day for 3 years Receives: Dietary Supplement: aglycone genistein | |
| 2 | Postmenopausal women with established osteopenia receiving placebo (Calcium and vitD) for 3 years Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Measured: basal and after 1 year
Mammographic breast density
Measured: basal and after 3 years
Secondary outcomes (11)
Bone-specific alkaline phosphatase (B-ALP)
Measured: basal and after 1 year
Insulin-like growth factor 1 (IGF-1)
Measured: basal and after 1 year
Pyridinium cross-links (pyridinoline and deoxypyridinoline)
Measured: basal and after 1 year
carboxy-terminal cross-linking telopeptide (CTX)
Measured: basal and after 1 year
Osteoprotegerin and soluble receptor activator of NF-kB ligand (s-RANKL)
Measured: basal and after 1 year
BRCA1 and BRCA2 mRNA levels
Measured: basal and after 3 years
Sister Chromatid exchanges
Measured: basal and after 3 years
Endometrial thickness
Measured: basal and after 3 years
Insulin resistance
Measured: basal and after 3 years
hot flushes
Measured: basal and after 3 years
Thyroid status
Measured: basal and after 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startJul 2005
- Primary completionJul 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Collaborators
- Primus Pharmaceuticals
- Investigators
- Francesco Squadrito, MD, Principal investigator, University of MessinaRosario D'Anna, MD, Study director, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626769
- Sponsor's protocol ID
- 2005-07
- Status last verified
- May 2009
- First submitted
- 19 Feb 2008
- Last updated
- 19 May 2009
- Results posted
- No
- Data monitoring committee
- 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 17577003Bitto A, Polito F, Atteritano M, Altavilla D, Mazzaferro S, Marini H, Adamo EB, D'Anna R, Granese R, Corrado F, Russo S, Minutoli L, Squadrito F. Genistein aglycone does not affect thyroid function: results from a three-year, randomized, double-blind, placebo-controlled trial. J Clin Endocrinol Metab. 2010 Jun;95(6):3067-72. doi: 10.1210/jc.2009-2779. Epub 2010 Mar 31.
PubMed 20357174Marini H, Bitto A, Altavilla D, Burnett BP, Polito F, Di Stefano V, Minutoli L, Atteritano M, Levy RM, D'Anna R, Frisina N, Mazzaferro S, Cancellieri F, Cannata ML, Corrado F, Frisina A, Adamo V, Lubrano C, Sansotta C, Marini R, Adamo EB, Squadrito F. Breast safety and efficacy of genistein aglycone for postmenopausal bone loss: a follow-up study. J Clin Endocrinol Metab. 2008 Dec;93(12):4787-96. doi: 10.1210/jc.2008-1087. Epub 2008 Sep 16.
PubMed 18796517
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile and Bone Efficacy of the Phytoestrogen Genistein in a Cohort of Osteopenic, Postmenopausal Women After Three Years of Treatment: a Follow-up Study
- ClinicalTrials.gov ID
- NCT00626769
- Acronym / sponsor ID
- 2005-07
- Conditions
- Menopause, Osteopenia
- Keywords
- Genistein, Bone mineral density, digital mammography, safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Collaborators
- Primus Pharmaceuticals
- Study start
- Jul 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 29 Feb 2008 (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.
BACKGROUND: Recent evidences showed that the phytoestrogen genistein positively affects bone metabolism with no clinically significant adverse effects in a cohort of osteopenic, postmenopausal women. However, there is still a knowledge gap regarding the long-term safety of genistein on the breast, the uterus, the thyroid gland and its efficacy in postmenopausal women.
OBJECTIVE: To assess the safety profile of genistein on mammary and thyroid glands and endometrium and cardiovascular apparatus and its effects on bone metabolism after a 3-year therapy with pure, standardized genistein (54 mg/day).
Detailed description
DESIGN: The parent study was a randomized, double-blind, placebo-controlled trial involving 389 osteopenic, postmenopausal women for 24 months. After the 24-month visit, a sub-population (138 patients) accepted to continue the intervention until 36 months, thus generating a follow-up study.
SETTING: 3 Italian university medical centers. INTERVENTIONS: Participants received 54 mg of genistein, daily, (n=71) or placebo (n=67). Both intervention and placebo contained calcium and vitamin D3. All patients also received dietary instruction in an isocaloric fat-reduced diet.
MEASUREMENTS: Mammographic breast density at baseline and after 24 and 36 months was assessed by visual classification scale and by digitized quantification. BRCA1 and BRCA2 molecular message, sister chromatid exchanges and endometrial thickness were also evaluated at the same time points. Measurements of lumbar spine and femoral neck BMD and QUS t-score were assayed in our patients. Secondary outcomes were serum levels of B-ALP, IGF-I, sRANKL, osteoprotegerin and urinary excretion of CTX, pyridinoline and deoxypyridinoline. Furthermore insulin resistance (HOMA-IR), glucose levels, homocysteine and hot flushes were also evaluated. In addition for thyroid safety TSH, fT3, fT4, thyroid autoantibodies, and mRNA for thyroid and retinoid receptors were evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Dietary Supplement: aglycone genisteinPostmenopausal women with established osteopenia receiving aglycone genistein 54 mg/day for 3 years |
| 2 | – | Dietary Supplement: placeboPostmenopausal women with established osteopenia receiving placebo (Calcium and vitD) for 3 years |
Who may qualify
- Ages
- 49 to 67 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women (age 49-67 yrs)
Key inclusion criteria (5 listed)
- Good general health
- Have not had a menstrual period in the preceding year
- Had not undergone surgically induced menopause
- Had a follicle-stimulating hormone level > 50 IU/liter and a serum 17 beta-estradiol level ≤ 100 pmol/liter
- Established osteopenia (-1<T-score<-2.5 SD)
Key exclusion criteria (7 listed)
- Clinical or laboratory evidence of confounding systemic diseases, such as cardiovascular, hepatic, or renal disorders
- Coagulopathy, use of oral or transdermal estrogen, progestin, androgen or other steroids
- Biphosphonates, cholesterol-lowering therapy or cardiovascular medications in the preceding six months
- Smoking habit of more than two cigarettes per day
- Previous treatment with any drug that could affect the skeleton in the preceding year
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 |
|---|---|---|
| aglycone genisteinAlso: Genivis, Fosteum2 capsules per day containing 27 mg of aglycone genistein, calcium carbonate (500 mg) and vitamin D (400 IU), for a 3-year period. | Dietary supplement | 1 |
| placebo2 capsules per day containing calcium carbonate (500 mg) and vitamin D (400 IU), for a 3-year period. | Dietary supplement | 2 |
Primary outcome
Bone Mineral Density
Time frame: basal and after 1 year
Mammographic breast density
Time frame: basal and after 3 years
11 secondary outcomes
Bone-specific alkaline phosphatase (B-ALP)
Time frame: basal and after 1 year
Insulin-like growth factor 1 (IGF-1)
Time frame: basal and after 1 year
Pyridinium cross-links (pyridinoline and deoxypyridinoline)
Time frame: basal and after 1 year
carboxy-terminal cross-linking telopeptide (CTX)
Time frame: basal and after 1 year
Osteoprotegerin and soluble receptor activator of NF-kB ligand (s-RANKL)
Time frame: basal and after 1 year
BRCA1 and BRCA2 mRNA levels
Time frame: basal and after 3 years
Sister Chromatid exchanges
Time frame: basal and after 3 years
Endometrial thickness
Time frame: basal and after 3 years
Insulin resistance
Time frame: basal and after 3 years
hot flushes
Time frame: basal and after 3 years
Thyroid status
Time frame: basal and after 3 years
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 19 May 2009.
- Background: 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.
- Derived from this study: PubMed 20357174Bitto A, Polito F, Atteritano M, Altavilla D, Mazzaferro S, Marini H, Adamo EB, D'Anna R, Granese R, Corrado F, Russo S, Minutoli L, Squadrito F. Genistein aglycone does not affect thyroid function: results from a three-year, randomized, double-blind, placebo-controlled trial. J Clin Endocrinol Metab. 2010 Jun;95(6):3067-72. doi: 10.1210/jc.2009-2779. Epub 2010 Mar 31.
- Derived from this study: PubMed 18796517Marini H, Bitto A, Altavilla D, Burnett BP, Polito F, Di Stefano V, Minutoli L, Atteritano M, Levy RM, D'Anna R, Frisina N, Mazzaferro S, Cancellieri F, Cannata ML, Corrado F, Frisina A, Adamo V, Lubrano C, Sansotta C, Marini R, Adamo EB, Squadrito F. Breast safety and efficacy of genistein aglycone for postmenopausal bone loss: a follow-up study. J Clin Endocrinol Metab. 2008 Dec;93(12):4787-96. doi: 10.1210/jc.2008-1087. Epub 2008 Sep 16.
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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 principal investigator
University of Messina
Rosario D'Anna, MD study director
University of Messina
Questions about this trial
What is this clinical trial studying?
An observational study of 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 5 inclusion and 7 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 19 May 2009. 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.
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?
Bone Mineral Density (time frame: basal and after 1 year). The study lists 2 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 NCT00626769, which also lists 3 linked publications.
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 19 May 2009.