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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936260
• Other study ID #: individual reseacher
• Status: Completed
• Phase: N/A
• First received: July 9, 2009
• Last updated: July 9, 2009
• Start date: January 1998
• Est. completion date: December 2004

Study information

• Verified date: January 1998
• Source: Ciudad Universitaria, Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• alendronate
several duration of treatment

Locations

Country	Name	City	State
Spain	University San Carlos Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Ciudad Universitaria, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density		Every year	Yes
Secondary	Fractures		Every year	No