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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00936260
First Posted: July 10, 2009
Last Update Posted: July 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ciudad Universitaria, Spain
  Purpose
The purpose of this study is to determine the duration of the treatment with alendronate in postmenopausal women with osteoporosis.

Condition Intervention
Osteoporosis Drug: alendronate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Ciudad Universitaria, Spain:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: Every year ]

Secondary Outcome Measures:
  • Fractures [ Time Frame: Every year ]

Enrollment: 228
Study Start Date: January 1998
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alendronate 6 years Drug: alendronate
several duration of treatment
Other Name: fosamax
Experimental: alendronate 5 years
No treatment during year 6th
Drug: alendronate
several duration of treatment
Other Name: fosamax
Experimental: alendronate 5 years, not continued
No treatment during year 5th
Drug: alendronate
several duration of treatment
Other Name: fosamax
Experimental: alendronate 4 years
No treatment during year 5th and 6th
Drug: alendronate
several duration of treatment
Other Name: fosamax
Experimental: alendronate 5 years, uncontinued
No treatment during year 4th
Drug: alendronate
several duration of treatment
Other Name: fosamax
Experimental: alendronate 4 years, not continued
No treatment during year 4th and 6th
Drug: alendronate
several duration of treatment
Other Name: fosamax
Experimental: alendronate 4 years, uncontinued
No treatment during year 4th and 5th
Drug: alendronate
several duration of treatment
Other Name: fosamax
Experimental: Alendronato 3 years
No treatment during the last 3 years
Drug: alendronate
several duration of treatment
Other Name: fosamax

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936260


Locations
Spain
University San Carlos Hospital
Madrid, Spain, 28040
Sponsors and Collaborators
Ciudad Universitaria, Spain
Investigators
Study Director: Carlos Lozano Tonkin, doctor university san carlos hospital
  More Information

Responsible Party: Esther Alvarez-Rodriguez, University San Carlos Hospital
ClinicalTrials.gov Identifier: NCT00936260     History of Changes
Other Study ID Numbers: individual reseacher
First Submitted: July 9, 2009
First Posted: July 10, 2009
Last Update Posted: July 10, 2009
Last Verified: January 1998

Keywords provided by Ciudad Universitaria, Spain:
osteoporosis
postmenopausal
alendronate

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs