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Completed

NCT Number: NCT00936260

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

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

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University San Carlos Hospital

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Alendronate

Drug

several duration of treatment

Other names: fosamax

Primary outcomes

  1. Bone mineral density

    Time frame: Every year

Secondary outcomes

  1. Fractures

    Time frame: Every year

Sponsors and collaborators

Lead sponsor

Ciudad Universitaria, Spain

Other

Registry information

Important dates

Study start
1998
Primary completion
2004
Study completion
2004
First posted
Jul 10, 2009
Registry last updated
Jul 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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