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

Ciudad Universitaria, Spain

Status: Completed

Conditions: Osteoporosis

Treatments: Drug: alendronate

Study type: Interventional

Funder types: Other

Identifiers

NCT00936260

individual reseacher

Details and patient eligibility

About

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

Full 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.

Enrollment: 228 patients

Sex: Female

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 8 patient groups

alendronate 6 years

Experimental group

Treatment:

Drug: alendronate

alendronate 5 years

Experimental group

Description:

No treatment during year 6th

Treatment:

Drug: alendronate

alendronate 5 years, not continued

Experimental group

Description:

No treatment during year 5th

Treatment:

Drug: alendronate

alendronate 4 years

Experimental group

Description:

No treatment during year 5th and 6th

Treatment:

Drug: alendronate

alendronate 5 years, uncontinued

Experimental group

Description:

No treatment during year 4th

Treatment:

Drug: alendronate

alendronate 4 years, not continued

Experimental group

Description:

No treatment during year 4th and 6th

Treatment:

Drug: alendronate

alendronate 4 years, uncontinued

Experimental group

Description:

No treatment during year 4th and 5th

Treatment:

Drug: alendronate

Alendronato 3 years

Experimental group

Description:

No treatment during the last 3 years

Treatment:

Drug: alendronate