Back to resultsDrug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
alendronate
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, postmenopausal, alendronate
Eligibility 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)
Sites / Locations
- University San Carlos Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
alendronate 6 years
alendronate 5 years
alendronate 5 years, not continued
alendronate 4 years
alendronate 5 years, uncontinued
alendronate 4 years, not continued
alendronate 4 years, uncontinued
Alendronato 3 years
Arm Description
No treatment during year 6th
No treatment during year 5th
No treatment during year 5th and 6th
No treatment during year 4th
No treatment during year 4th and 6th
No treatment during year 4th and 5th
No treatment during the last 3 years
Outcomes
Primary Outcome Measures
Bone mineral density
Secondary Outcome Measures
Fractures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00936260
Brief Title
Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis
Official Title
Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 1998
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ciudad Universitaria, Spain
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
osteoporosis, postmenopausal, alendronate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
alendronate 6 years
Arm Type
Experimental
Arm Title
alendronate 5 years
Arm Type
Experimental
Arm Description
No treatment during year 6th
Arm Title
alendronate 5 years, not continued
Arm Type
Experimental
Arm Description
No treatment during year 5th
Arm Title
alendronate 4 years
Arm Type
Experimental
Arm Description
No treatment during year 5th and 6th
Arm Title
alendronate 5 years, uncontinued
Arm Type
Experimental
Arm Description
No treatment during year 4th
Arm Title
alendronate 4 years, not continued
Arm Type
Experimental
Arm Description
No treatment during year 4th and 6th
Arm Title
alendronate 4 years, uncontinued
Arm Type
Experimental
Arm Description
No treatment during year 4th and 5th
Arm Title
Alendronato 3 years
Arm Type
Experimental
Arm Description
No treatment during the last 3 years
Intervention Type
Drug
Intervention Name(s)
alendronate
Other Intervention Name(s)
fosamax
Intervention Description
several duration of treatment
Primary Outcome Measure Information:
Title
Bone mineral density
Time Frame
Every year
Secondary Outcome Measure Information:
Title
Fractures
Time Frame
Every year
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Lozano Tonkin, doctor
Organizational Affiliation
university san carlos hospital
Official's Role
Study Director
Facility Information:
Facility Name
University San Carlos Hospital
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis
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