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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00936260

Enrollment

228

Registered

2009-07-10

Start date

1998-01-31

Completion date

2004-12-31

Last updated

2009-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

osteoporosis, postmenopausal, alendronate

Brief summary

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

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.

Interventions

DRUGalendronate

several duration of treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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)

Design outcomes

Primary

Measure	Time frame
Bone mineral density	Every year

Secondary

Measure	Time frame
Fractures	Every year

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026