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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-013274-41-IT
Enrollment
Unknown
Registered
2010-04-27
Start date
2010-05-10
Completion date
Unknown
Last updated
2012-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postmenopausal osteoporosis MedDRA version: 9.1 Level: LLT Classification code 10031285

Interventions

Trade Name: DIFOSFONAL*10CPS 400MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: Clodronic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Prod

Sponsors

SOCIETA` PRODOTTI ANTIBIOTICI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: To demostrate non-inferiority on the mineral density bone of oral clodronate administered at a 800 mg daily dose and intramuscularly clodronate at a 200 mg once every 2 weeks dose versus intramuscularly clodronate at a 100 mg weekly dose.;Secondary Objective: To demostrate the non-inferiority on markers of bone metabolism of oral clodronate administered at a dose of 800 mg To document non-inferiority of oral clodronate at a 800 mg daily dose and intramuscularly clodronate at a 200 mg every 2 weeks dose versus intramuscularly clodronate at a 100 mg weekly dose;Primary end point(s): Primary efficacy parameter is BMD at the lumbar segment L1-L4.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026