- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00936260
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
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:
|
Experimental: alendronate 5 years
No treatment during year 6th
|
several duration of treatment
Other Names:
|
Experimental: alendronate 5 years, not continued
No treatment during year 5th
|
several duration of treatment
Other Names:
|
Experimental: alendronate 4 years
No treatment during year 5th and 6th
|
several duration of treatment
Other Names:
|
Experimental: alendronate 5 years, uncontinued
No treatment during year 4th
|
several duration of treatment
Other Names:
|
Experimental: alendronate 4 years, not continued
No treatment during year 4th and 6th
|
several duration of treatment
Other Names:
|
Experimental: alendronate 4 years, uncontinued
No treatment during year 4th and 5th
|
several duration of treatment
Other Names:
|
Experimental: Alendronato 3 years
No treatment during the last 3 years
|
several duration of treatment
Other Names:
|
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- individual reseacher
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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