A NON-INVASIVE EVALUATION OF BONE MICROARCHITECTURE MODIFICATION IN OSTEOPENIC POSTMENOPAUSAL WOMEN BY 3D-PERIPHERAL QUANTITATIVE COMPUTED TOMOGRAPHY : A 24-MONTH, MONOCENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY COMPARING WEEKLY ORAL RISEDRONATE 35 MG AND PLACEBO - OSMAUSE

sanofi-aventis Groupe0 sitesMarch 13, 2006

DrugsACTONEL 35 mg, comprimé pelliculé OROCAL D3

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: sanofi-aventis Groupe
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 13, 2006

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

sanofi-aventis Groupe

Eligibility Criteria

Inclusion Criteria

•Women meeting all of the following criteria are eligible for randomization into the study:
•a)ambulatory ;
•b)between 55 and 75 years of age, inclusive ;
•c)spontaneous cessation of menstruation since at least 12 months prior to study enrollment
•d)has osteopenia defined as having the following :
•Lumbar spine (L1 through L4\)
•BMD T\-score of \-1 to \-2\.5
•Hologic: 0\.937 g/cm2 to 0\.772 g/cm2
•Lunar:1\.060 g/cm2 to 0\.882 g/cm2
•A total hip T\-score of \>ou \=\-2\.5

Exclusion Criteria

•Patients will not be admitted into the study if they exhibit any of the following :
•a)documented history of illicit drug abuse or alcohol abuse (for the past 2 years) ;
•b)evidence of significant psychiatric or organic disease (particularly a history of malignant disease \[excluding skin epitheliomas], gastrointestinal, hepatic, renal, or cardiac disease), which, in the opinion of the investigator and the medical monitor, would prevent the patient from completing the study ;
•c)history of tremor disorder ;
•d)history of recent (\<6 months) primary hyperparathyroidism or recent thyroid disorder ;
•e)history of any generalized bone disease, including progressive hyperparathyroidism, Paget's disease of bone, renal osteodystrophy, or any other acquired or congenital bone disease, or any known condition that would interfere with the assessment of DXA at either the lumbar spine (\>ou\= 3 non\-evaluable lumbar vertebrae at lumbar spine L1 – L4\) or the femoral neck ;
•f)clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (\>ou\= 20% reduction in anterior\-to\-posterior or middle\-to\-posterior height ratio ; or \>ou\= 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal X\-ray or a history of osteoporosis\-related atraumatic fracture of the hip or of the wrist ;
•g)glucocorticoid\-induced osteopenia ;
•h)previous IV bisphonate therapy
•i)oral bisphosphonate therapy for \> 3 months in the past 3 years ;