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

This study has been completed.
Sponsor:
Information provided by:
Ciudad Universitaria, Spain
ClinicalTrials.gov Identifier:
NCT00936260
First received: July 9, 2009
Last updated: NA
Last verified: January 1998
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Fractures [ Time Frame: Every year ] [ Designated as safety issue: No ]

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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Esther Alvarez-Rodriguez, University San Carlos Hospital
ClinicalTrials.gov Identifier: NCT00936260     History of Changes
Other Study ID Numbers: individual reseacher
Study First Received: July 9, 2009
Last Updated: July 9, 2009
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Ciudad Universitaria, Spain:
osteoporosis
postmenopausal
alendronate

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

ClinicalTrials.gov processed this record on April 22, 2014