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Osteoporosis Prevention With Low Dose Alendronate

Primary Purpose

Osteopenia

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
alendronate
Calcium/Vitamin D
placebo
Sponsored by
University Hospital of Mont-Godinne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteopenia focused on measuring osteopenia, osteoporosis prevention, alendronate

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University (UCL) Louvain Hospital in Mont-Godinne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Alendronate 70 mg every 2 weeks

Alendronate 70 mg placebo tablet every 2 weeks

Outcomes

Primary Outcome Measures

percentage of lumbar BMD modification after 2 years

Secondary Outcome Measures

percentage of hip BMD modification (total hip and sub-regions)
percentage of modification of bone remodeling markers

Full Information

First Posted
April 19, 2007
Last Updated
May 28, 2013
Sponsor
University Hospital of Mont-Godinne
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1. Study Identification

Unique Protocol Identification Number
NCT00463268
Brief Title
Osteoporosis Prevention With Low Dose Alendronate
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Mont-Godinne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
Keywords
osteopenia, osteoporosis prevention, alendronate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Alendronate 70 mg every 2 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Alendronate 70 mg placebo tablet every 2 weeks
Intervention Type
Drug
Intervention Name(s)
alendronate
Intervention Description
alendronate 70 mg every 2 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium/Vitamin D
Intervention Description
Calcium 500 mg and vitamin D supplementation according to serum level
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
identical placebo every 2 weeks
Primary Outcome Measure Information:
Title
percentage of lumbar BMD modification after 2 years
Time Frame
2 years
Secondary Outcome Measure Information:
Title
percentage of hip BMD modification (total hip and sub-regions)
Time Frame
2 years
Title
percentage of modification of bone remodeling markers
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves R Boutsen, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
University (UCL) Louvain Hospital in Mont-Godinne
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium

12. IPD Sharing Statement

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Osteoporosis Prevention With Low Dose Alendronate

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