Status:
COMPLETED
Third Year Evaluation on Genistein Efficacy and Safety
Lead Sponsor:
University of Messina
Collaborating Sponsors:
Primus Pharmaceuticals
Conditions:
Menopause
Osteopenia
Eligibility:
FEMALE
49-67 years
Brief 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. ...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00626769
Start Date
July 1 2005
End Date
September 1 2006
Last Update
May 19 2009
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