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

Information source: Ciudad Universitaria, Spain
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: alendronate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Ciudad Universitaria, Spain

Official(s) and/or principal investigator(s):
Carlos Lozano Tonkin, doctor, Study Director, Affiliation: university san carlos hospital


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

Clinical Details

Official title: Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bone mineral density

Secondary outcome: Fractures

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.


Minimum age: N/A. Maximum age: N/A. Gender(s): Female.


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)

Locations and Contacts

University San Carlos Hospital, Madrid 28040, Spain
Additional Information

Starting date: January 1998
Last updated: July 9, 2009

Page last updated: August 20, 2015

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