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