Osteoporosis Prevention With Low Dose Alendronate

University Hospital of Mont-Godinne83 enrolled

Overview

The purpose of this study is to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Osteopenia

Interventions

alendronateDRUG

alendronate 70 mg every 2 weeks

Calcium/Vitamin DDIETARY_SUPPLEMENT

Calcium 500 mg and vitamin D supplementation according to serum level

placeboDRUG

identical placebo every 2 weeks

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 45 to 60 year-old women * Menopausal since at least 6 months * Baseline lumbar BMD from -1 till -2.5 Exclusion Criteria: * Bone disease other than osteopenia * Treatment with selective estrogen receptor modulator (SERMs), calcitonin or hormone replacement therapy within 6 monts prior to randomization * Former or current treatment with any bisphosphonate or bone forming agents * Chronic use of oral or iv corticosteroids * Any diagnosis of malignancy less than 12 months

Locations (1)

University (UCL) Louvain Hospital in Mont-Godinne

Yvoir, Namur, Belgium

Outcomes

Primary Outcomes

percentage of lumbar BMD modification after 2 years

Time frame: 2 years

Secondary Outcomes

percentage of hip BMD modification (total hip and sub-regions)

Time frame: 2 years

percentage of modification of bone remodeling markers

Time frame: 2 years

Data from ClinicalTrials.gov

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