Role of Estrogens in osteoclastogenesis and immunomodulation of T cells. - ND

• Conditions: post-menopausal osteoporosis; MedDRA version: 9.1Level: LLTClassification code 10031282Term: Osteoporosis

• Registration Number: EUCTR2008-007404-28-IT
• Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

a.BMD T-score equal or lower -2.5 S.D. according toWHO (WHO Technical Report Series nr 843 ?Assessment of fracture risk and the application to screening for post,enopausal osteoporosis?, 1994). With or without fractures
All the women will be in postmenopausal period since at least one year
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a.legal inhability to give the consent
b.secondary osteoporosis
c.threapy with calcium and vitamin D, thyroid hormones, corticosteroids, estrogens, bisphosphonastes, parthyroid hormone, fluorures, strontium ranelate and raloxifene in the last six months
d.Immunosuppressive therapy (ciclosporin, azathyoprine) in the last year
e.presence of previous adverse events with the drugs in study
f.previous history of cancer
g.previous histoy of venous, retinic or pulmonary tromboembolism, or othero coaugulopathies
h.history of hepatopathy
i.histerectomy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the present study is to investigate the effect of hormone replacement therapy (HRT) and of Raloxifene (RLX) in reducing osteoclast formation and activity and their posiible influence on T cells activation.;Secondary Objective: Effect of therapy on bone turnover;Primary end point(s): To investigate the effect of hormone replacement therapy (HRT) and of Raloxifene (RLX) in reducing osteoclast formation and activity and their posiible influence on T cells activation.