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Osteoporosis Prevention With Low Dose Alendronate

Information source: University Hospital of Mont-Godinne
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteopenia

Intervention: alendronate (Drug); Calcium/Vitamin D (Dietary Supplement); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University Hospital of Mont-Godinne

Official(s) and/or principal investigator(s):
Yves R Boutsen, MD, Principal Investigator


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.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: percentage of lumbar BMD modification after 2 years

Secondary outcome:

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

percentage of modification of bone remodeling markers


Minimum age: 45 Years. Maximum age: 60 Years. Gender(s): Female.


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 and Contacts

University (UCL) Louvain Hospital in Mont-Godinne, Yvoir, Namur 5530, Belgium
Additional Information

Starting date: September 2007
Last updated: May 28, 2013

Page last updated: August 20, 2015

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