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

Study Overview
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Brief Summary
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The purpose of this study is to determine the duration of the treatment with alendronate in postmenopausal women with osteoporosis.

Detailed Description
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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.

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

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: alendronate


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alendronate 6 years<br> | Drug: alendronate<br>* several duration of treatment<br>* Other names: fosamax;|
| Experimental: alendronate 5 years<br>No treatment during year 6th | Drug: alendronate<br>* several duration of treatment<br>* Other names: fosamax;|
| Experimental: alendronate 5 years, not continued<br>No treatment during year 5th | Drug: alendronate<br>* several duration of treatment<br>* Other names: fosamax;|
| Experimental: alendronate 4 years<br>No treatment during year 5th and 6th | Drug: alendronate<br>* several duration of treatment<br>* Other names: fosamax;|
| Experimental: alendronate 5 years, uncontinued<br>No treatment during year 4th | Drug: alendronate<br>* several duration of treatment<br>* Other names: fosamax;|
| Experimental: alendronate 4 years, not continued<br>No treatment during year 4th and 6th | Drug: alendronate<br>* several duration of treatment<br>* Other names: fosamax;|
| Experimental: alendronate 4 years, uncontinued<br>No treatment during year 4th and 5th | Drug: alendronate<br>* several duration of treatment<br>* Other names: fosamax;|
| Experimental: Alendronato 3 years<br>No treatment during the last 3 years | Drug: alendronate<br>* several duration of treatment<br>* Other names: fosamax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density |  | Every year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractures |  | Every year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, postmenopausal, alendronate