Multicenter, randomized, parallel group open study to compare, in patients with postmenopausal osteoporosis, the effects of clodronate (Difosfonal) administered either intramuscularly at a dose of 100 mg 1 weekly, intramuscularly at a dose of 200 mg once every 2 weeks or orally at a dose of 800 mg daily (400 mg x 2), on BMD and markers of bone metabolism. - ND

• Conditions: postmenopausal osteoporosis; MedDRA version: 9.1Level: LLTClassification code 10031285

• Registration Number: EUCTR2009-013274-41-IT
• Lead Sponsor: SOCIETA` PRODOTTI ANTIBIOTICI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-27
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

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

Inclusion Criteria

Written informed consent to participate; subject-menopausal women with amenorrhea present for at least 3 years; age between 55 and 70 years; bone mineral density (BMD) T-score between -4.0 and - 2.5 at femoral neck or lower than - 2.5 at lumbar spine (L1-L4);
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

History of previous hip fragility attributable to osteoporosis; vertebral fractures (reduction of 4 mm or 15% of one or more of the three vertebral heights); femoral BMD T-score lower than -3.0 SD with a history of wrist fractures, family history of vertebral fractures, menopause at the age of 45 years or before;previous treatments with bisphosphonates and other active compounds on bone metabolism, chronic steroid therapy; thyroid TSH suppressive therapy; treatment with calcium in over 500 mg / day and vitamin D over 5000 IU / week or equivalent dosage; poor oral hygiene or inadequate dental health; invasive dental procedures already planned and to be performed during the study period; known hypersensitivity to study drug (cloronic acid)or to bisphosphonates or to other excipients in the drug formulations; known hypersensitivity to lidocaine or other local amide type of anesthetics (eg. Bupivacaine, mepivacaine, ropivacaine, levobupivacaine); other controindication to the study medications or other ingredients of the drug formuoatons.

Study & Design

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