A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

The purpose of this study is to compare how well alendronate and raloxifene increase the bone density in women who have osteoporosis and have experienced menopause.

Completed

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient is postmenopausal (or surgically menopausal) for at least 6 months
Patient must be diagnosed with osteoporosis
Patient has spinal anatomy suitable for DEXA of the lumbar spine

Exclusion criteria

Patient is receiving or has received treatment prior to randomization which might influence bone turnover
Patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss)
Patient is receiving or is expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism

Treatment and study plan

MK0217, /Duration of Treatment : 12 Months

Drug

Comparator : raloxifene hydrochloride /Duration of Treatment : 12 Months

Drug

Primary outcomes

Bone Mineral Density (BMD) in PA lumbar spine at 12 months

Secondary outcomes

Bone Mineral Density (BMD) in hip at 12 months; bone turnover at 6 and 12 months

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Alendronate and Raloxifene on Bone Mineral Density in Postmenopausal Women With Osteoporosis

Important dates

Study start: 2001
Primary completion: 2003
Study completion: 2003
First posted: Oct 19, 2006
Registry last updated: Aug 14, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed