Prevention of Postmenopausal Bone Loss in Osteopenic Women with Alendronate given on a 70 mg Once-every two week Regimen : a 2-year, Double-blind, Placebo-controlled Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005862-38-BE

Enrollment

150

Registered

2007-03-16

Start date

2007-04-05

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

osteopenia and postmenopausal patient

Interventions

Trade Name: Alendronate Product Name: FOSAMAX Pharmaceutical Form: Tablet CAS Number: 121268175 Other descriptive name: ALENDRONATE SODIUM Pharmaceutical form of the placebo: Tablet Route of administr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - female aged 45-60 years, - post menopausal for at least 6 months, - BMD between -1 and -2.5 T-scores, 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - former treatment susceptible of modifying the bone metabolism

Design outcomes

Primary

Measure	Time frame
Main Objective: - to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as bone loss prevention for menopausal, osteopenic patients, who don't want or can't receive an estrogenic substitution treatment ;Secondary Objective: primary endpoint : % of lumbar BMD modification after 2 years secondary endpoint : % of hip BMD modification, % modification of bone remodeling markers;Primary end point(s): % of lumbar BMD modification after 2 years	—

Measure

Time frame

Main Objective: - to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as bone loss prevention for menopausal, osteopenic patients, who don't want or can't receive an estrogenic substitution treatment ;Secondary Objective: primary endpoint : % of lumbar BMD modification after 2 years secondary endpoint : % of hip BMD modification, % modification of bone remodeling markers;Primary end point(s): % of lumbar BMD modification after 2 years

—

Countries

Belgium

Outcome results

None listed

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