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Osteoporosis Prevention With Low Dose Alendronate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00463268
First Posted: April 20, 2007
Last Update Posted: May 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boutsen Yves, University Hospital of Mont-Godinne
  Purpose
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.

Condition Intervention Phase
Osteopenia Drug: alendronate Dietary Supplement: Calcium/Vitamin D Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • percentage of lumbar BMD modification after 2 years [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • percentage of hip BMD modification (total hip and sub-regions) [ Time Frame: 2 years ]
  • percentage of modification of bone remodeling markers [ Time Frame: 2 years ]

Enrollment: 83
Study Start Date: September 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Alendronate 70 mg every 2 weeks
Drug: alendronate
alendronate 70 mg every 2 weeks
Dietary Supplement: Calcium/Vitamin D
Calcium 500 mg and vitamin D supplementation according to serum level
Placebo Comparator: 2
Alendronate 70 mg placebo tablet 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463268


Locations
Belgium
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
  More Information

Responsible Party: Boutsen Yves, professeur, University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier: NCT00463268     History of Changes
Other Study ID Numbers: MG/OP 001
First Submitted: April 19, 2007
First Posted: April 20, 2007
Last Update Posted: May 29, 2013
Last Verified: May 2013

Keywords provided by Boutsen Yves, University Hospital of Mont-Godinne:
osteopenia
osteoporosis prevention
alendronate

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Alendronate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents