NCT00463268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

4.3 years

First QC Date

April 19, 2007

Last Update Submit

May 28, 2013

Conditions

Osteopenia

Keywords

osteopeniaosteoporosis preventionalendronate

Outcome Measures

Primary Outcomes (1)

  • percentage of lumbar BMD modification after 2 years

    2 years

Secondary Outcomes (2)

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

    2 years

  • percentage of modification of bone remodeling markers

    2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Alendronate 70 mg every 2 weeks

Drug: alendronateDietary Supplement: Calcium/Vitamin D

2

PLACEBO COMPARATOR

Alendronate 70 mg placebo tablet every 2 weeks

Dietary Supplement: Calcium/Vitamin DDrug: placebo

Interventions

alendronateDRUG

alendronate 70 mg every 2 weeks

1
Calcium/Vitamin DDIETARY_SUPPLEMENT

Calcium 500 mg and vitamin D supplementation according to serum level

12
placeboDRUG

identical placebo every 2 weeks

2

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 60 year-old women
  • Menopausal since at least 6 months
  • Baseline lumbar BMD from -1 till -2.5

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University (UCL) Louvain Hospital in Mont-Godinne

Yvoir, Namur, 5530, Belgium

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

AlendronateCalciumVitamin D

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Yves R Boutsen, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professeur

Study Record Dates

First Submitted

April 19, 2007

First Posted

April 20, 2007

Study Start

September 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

BE(1)