Post-menopausal osteoporosis MedDRA version: 12.0 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal
Conditions
Interventions
Trade Name: PREOTACT*6 CART 1,61MG 100MCG
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Parathyroid hormone
Concentration unit: µg microgram(s)
Concentration
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: T-score of bone mineral density (BMD) equal or lower than -2.5 S.D. according with WHO (WHO Technical Report Series nr 843 ?Assessment of fracture risk and the application to screening for postmenopausal osteoporosis?, 1994), with or without fracture. - spontaneous menopause for 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: - mental or legal inability to do informative consent - secondary osteoporosis - patients taking drugs active on bone or glucose metabolism - diabetes or impaired glucose tolerance (IGT) - cancer history - surgical menopasuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To observe if the administration of intermittent subcutaneous 1-84 PTH 100 ?g (Preotact) plus calcium 1200 mg and vitamin D 800 UI (Natecal D3) daily, in comparison with only calcium and vitamin D, influences: - glucose tolerance, estimated with an oral glucose tolerance test (OGTT) with 75 g of glucose at the beginning and after 6 and 18 months of therapy - body fat distribution, estimated with total-body X ray densitometry by QDR 4500 X-Ray densitometer at the beginning and after 18 months of therapy - the levels of adipokines (leptin and adiponectin), total osteocalcin and uncarboxylated osteocalcin, measured at the beginning and after 3, 6, 12 and 18 months of therapy;Secondary Objective: to evaluate if bone metabolism is able to influence energy expenditure.;Primary end point(s): To evaluate if the intermittent administration of 1-84 PTH could influence glucose tolerance and energy expenditure through its anabolic action on the skeleton. | — |
Countries
Italy
Outcome results
None listed