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

NCT ID: NCT00936260

Last Updated: 2009-07-10

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2004-12-31

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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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alendronate 6 years

Group Type EXPERIMENTAL

alendronate

Intervention Type DRUG

several duration of treatment

alendronate 5 years

No treatment during year 6th

Group Type EXPERIMENTAL

alendronate

Intervention Type DRUG

several duration of treatment

alendronate 5 years, not continued

No treatment during year 5th

Group Type EXPERIMENTAL

alendronate

Intervention Type DRUG

several duration of treatment

alendronate 4 years

No treatment during year 5th and 6th

Group Type EXPERIMENTAL

alendronate

Intervention Type DRUG

several duration of treatment

alendronate 5 years, uncontinued

No treatment during year 4th

Group Type EXPERIMENTAL

alendronate

Intervention Type DRUG

several duration of treatment

alendronate 4 years, not continued

No treatment during year 4th and 6th

Group Type EXPERIMENTAL

alendronate

Intervention Type DRUG

several duration of treatment

alendronate 4 years, uncontinued

No treatment during year 4th and 5th

Group Type EXPERIMENTAL

alendronate

Intervention Type DRUG

several duration of treatment

Alendronato 3 years

No treatment during the last 3 years

Group Type EXPERIMENTAL

alendronate

Intervention Type DRUG

several duration of treatment

Interventions

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alendronate

several duration of treatment

Intervention Type DRUG

Other Intervention Names

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fosamax

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)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ciudad Universitaria, Spain

OTHER

Sponsor Role lead

Responsible Party

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University San Carlos Hospital

Principal Investigators

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Carlos Lozano Tonkin, doctor

Role: STUDY_DIRECTOR

university san carlos hospital

Locations

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University San Carlos Hospital

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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individual reseacher

Identifier Type: -

Identifier Source: org_study_id

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