Osteoporosis Prevention With Low Dose Alendronate

NCT ID: NCT00463268

Last Updated: 2013-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Alendronate 70 mg every 2 weeks

Group Type ACTIVE_COMPARATOR

alendronate

Intervention Type DRUG

alendronate 70 mg every 2 weeks

Calcium/Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Calcium 500 mg and vitamin D supplementation according to serum level

2

Alendronate 70 mg placebo tablet every 2 weeks

Group Type PLACEBO_COMPARATOR

Calcium/Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Calcium 500 mg and vitamin D supplementation according to serum level

placebo

Intervention Type DRUG

identical placebo every 2 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

alendronate

alendronate 70 mg every 2 weeks

Intervention Type DRUG

Calcium/Vitamin D

Calcium 500 mg and vitamin D supplementation according to serum level

Intervention Type DIETARY_SUPPLEMENT

placebo

identical placebo every 2 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital of Mont-Godinne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Boutsen Yves

professeur

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yves R Boutsen, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University (UCL) Louvain Hospital in Mont-Godinne

Yvoir, Namur, Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MG/OP 001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Osteoporosis and Dental Implant
NCT00727493 UNKNOWN PHASE4