Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis

July 9, 2009 updated by: Ciudad Universitaria, Spain
The purpose of this study is to determine the duration of the treatment with alendronate in postmenopausal women with osteoporosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The duration of the treatment with alendronate is not well established. The investigators recruited 228 women with postmenopausal osteoporosis. They all received alendronate during the first 3 years of monitoring and were later on randomized to whether different regimens of intermittent treatment or to carry on 3 years more.

Study Type

Interventional

Enrollment (Actual)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Madrid, Spain, 28040
        • University San Carlos Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • postmenopausal osteoporosis under densitometric criteria of the World Health Organization

Exclusion Criteria:

  • secondary osteoporosis
  • alteration in analytic parameters (total proteins, calcium, phosphorus, vitamin D, parathyroid hormone, thyroid hormone, transaminase, creatinine)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: alendronate 6 years
several duration of treatment
Other Names:
  • fosamax
Experimental: alendronate 5 years
No treatment during year 6th
several duration of treatment
Other Names:
  • fosamax
Experimental: alendronate 5 years, not continued
No treatment during year 5th
several duration of treatment
Other Names:
  • fosamax
Experimental: alendronate 4 years
No treatment during year 5th and 6th
several duration of treatment
Other Names:
  • fosamax
Experimental: alendronate 5 years, uncontinued
No treatment during year 4th
several duration of treatment
Other Names:
  • fosamax
Experimental: alendronate 4 years, not continued
No treatment during year 4th and 6th
several duration of treatment
Other Names:
  • fosamax
Experimental: alendronate 4 years, uncontinued
No treatment during year 4th and 5th
several duration of treatment
Other Names:
  • fosamax
Experimental: Alendronato 3 years
No treatment during the last 3 years
several duration of treatment
Other Names:
  • fosamax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone mineral density
Time Frame: Every year
Every year

Secondary Outcome Measures

Outcome Measure
Time Frame
Fractures
Time Frame: Every year
Every year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Carlos Lozano Tonkin, doctor, University San Carlos Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (Estimate)

July 10, 2009

Study Record Updates

Last Update Posted (Estimate)

July 10, 2009

Last Update Submitted That Met QC Criteria

July 9, 2009

Last Verified

January 1, 1998

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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