post-menopausal osteoporosis MedDRA version: 9.1 Level: LLT Classification code 10031282 Term: Osteoporosis
Conditions
Interventions
Trade Name: ESTALIS SEQUI*4CER 50MCG+4 CER
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: ESTRADIOLO CIPIONATO
CAS Number: 206-237-8
Concentration unit: µg microgram(s)
Concentration type
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed