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Osteoporosis Prevention With Low Dose Alendronate

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier:
NCT00463268
First received: April 19, 2007
Last updated: February 19, 2009
Last verified: February 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • percentage of lumbar BMD modification after 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • percentage of hip BMD modification (total hip and sub-regions) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • percentage of modification of bone remodeling markers [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2007
Estimated Study Completion Date: January 2012
Estimated 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

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

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

No publications provided

Responsible Party: Louvain University, University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier: NCT00463268     History of Changes
Other Study ID Numbers: MG/OP 001
Study First Received: April 19, 2007
Last Updated: February 19, 2009
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

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

ClinicalTrials.gov processed this record on May 23, 2013