Osteoporosis Prevention With Low Dose Alendronate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boutsen Yves, University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier:
NCT00463268
First received: April 19, 2007
Last updated: May 28, 2013
Last verified: May 2013
  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:


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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Boutsen Yves, professeur, 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: May 28, 2013
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 July 22, 2014