Osteoporosis Prevention With Low Dose Alendronate

Osteopenia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463268
• Other study ID #: MG/OP 001
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2007
• Last updated: May 28, 2013
• Start date: September 2007
• Est. completion date: January 2012

Study information

• Verified date: May 2013
• Source: University Hospital of Mont-Godinne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteopenia

Intervention

Drug:
• alendronate
alendronate 70 mg every 2 weeks

Dietary Supplement:
• Calcium/Vitamin D
Calcium 500 mg and vitamin D supplementation according to serum level

Drug:
• placebo
identical placebo every 2 weeks

Locations

Country	Name	City	State
Belgium	University (UCL) Louvain Hospital in Mont-Godinne	Yvoir	Namur

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Mont-Godinne

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of lumbar BMD modification after 2 years		2 years	No
Secondary	percentage of hip BMD modification (total hip and sub-regions)		2 years	No
Secondary	percentage of modification of bone remodeling markers		2 years	No