Osteoporosis Prevention With Low Dose Alendronate

This study is not yet open for participant recruitment.

Verified by University Hospital of Mont-Godinne, April 2007

Sponsored by:	University Hospital of Mont-Godinne
Information provided by:	University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier:	NCT00463268

Purpose

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.

Condition	Intervention	Phase
Osteopenia	Drug: alendronate	Phase III

MedlinePlus related topics: Osteoporosis

Drug Information available for: Alendronate Alendronate sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by University Hospital of Mont-Godinne:

Primary Outcome Measures:

percentage of lumbar BMD modification after 2 years

Secondary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2009

Eligibility

Ages Eligible for Study:	45 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463268

Contacts

Contact: Yves R Boutsen, MD

+32.81.42.33.81

boutsen@mint.ucl.ac.be

Locations

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

Sponsors and Collaborators

University Hospital of Mont-Godinne

Investigators

Principal Investigator:

Yves R Boutsen, MD

Unaffiliated

More Information

Study ID Numbers:	MG/OP 001
Study First Received:	April 19, 2007
Last Updated:	April 19, 2007
ClinicalTrials.gov Identifier:	NCT00463268
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by University Hospital of Mont-Godinne:

osteopenia
osteoporosis prevention
alendronate

Study placed in the following topic categories:

Musculoskeletal Diseases
Alendronate
Osteoporosis, Postmenopausal

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009