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OpenTrials
Completed

NCT Number: NCT00463268

Osteoporosis Prevention With Low Dose Alendronate

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.

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Key information

Conditions

Osteopenia Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University (UCL) Louvain Hospital in Mont-Godinne

Yvoir, Namur, 5530, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alendronate

Drug

alendronate 70 mg every 2 weeks

Calcium/Vitamin D

Dietary Supplement

Calcium 500 mg and vitamin D supplementation according to serum level

Placebo

Drug

identical placebo every 2 weeks

Primary outcomes

  1. percentage of lumbar BMD modification after 2 years

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

  2. percentage of modification of bone remodeling markers

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University Hospital of Mont-Godinne

Other

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2007
Registry last updated
May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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