Energy metabolism and the skeleton: reciprocal interplay. - ND

• Conditions: Post-menopausal osteoporosis; MedDRA version: 12.0Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal

• Registration Number: EUCTR2009-012397-12-IT
• Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

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

- 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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.