NCT00936260

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 1998

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
Last Updated

July 10, 2009

Status Verified

January 1, 1998

Enrollment Period

6.9 years

First QC Date

July 9, 2009

Last Update Submit

July 9, 2009

Conditions

Osteoporosis

Keywords

osteoporosispostmenopausalalendronate

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

    Every year

Secondary Outcomes (1)

  • Fractures

    Every year

Study Arms (8)

alendronate 6 years

EXPERIMENTAL
Drug: alendronate

alendronate 5 years

EXPERIMENTAL

No treatment during year 6th

Drug: alendronate

alendronate 5 years, not continued

EXPERIMENTAL

No treatment during year 5th

Drug: alendronate

alendronate 4 years

EXPERIMENTAL

No treatment during year 5th and 6th

Drug: alendronate

alendronate 5 years, uncontinued

EXPERIMENTAL

No treatment during year 4th

Drug: alendronate

alendronate 4 years, not continued

EXPERIMENTAL

No treatment during year 4th and 6th

Drug: alendronate

alendronate 4 years, uncontinued

EXPERIMENTAL

No treatment during year 4th and 5th

Drug: alendronate

Alendronato 3 years

EXPERIMENTAL

No treatment during the last 3 years

Drug: alendronate

Interventions

alendronateDRUG

several duration of treatment

Also known as: fosamax
Alendronato 3 yearsalendronate 4 yearsalendronate 4 years, not continuedalendronate 4 years, uncontinuedalendronate 5 yearsalendronate 5 years, not continuedalendronate 5 years, uncontinuedalendronate 6 years

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • postmenopausal osteoporosis under densitometric criteria of the World Health Organization

You may not qualify if:

  • secondary osteoporosis
  • alteration in analytic parameters (total proteins, calcium, phosphorus, vitamin D, parathyroid hormone, thyroid hormone, transaminase, creatinine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University San Carlos Hospital

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Carlos Lozano Tonkin, doctor

    university san carlos hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 10, 2009

Study Start

January 1, 1998

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

July 10, 2009

Record last verified: 1998-01

Locations

ES(1)