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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00463268
Other study ID # MG/OP 001
Secondary ID
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


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
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