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

Osteoporosis, Postmenopausal Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389740
• Other study ID #: 0217-189
• Secondary ID: 2006_537
• Status: Completed
• Phase: Phase 3
• Start date: April 2, 2001
• Est. completion date: January 16, 2003

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 16, 2003
• Est. primary completion date: January 16, 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• MK0217, /Duration of Treatment : 12 Months

• Comparator : raloxifene hydrochloride /Duration of Treatment : 12 Months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Luckey M, Kagan R, Greenspan S, Bone H, Kiel RD, Simon J, Sackarowitz J, Palmisano J, Chen E, Petruschke RA, de Papp AE. Once-weekly alendronate 70 mg and raloxifene 60 mg daily in the treatment of postmenopausal osteoporosis. Menopause. 2004 Jul-Aug;11(4):405-15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density (BMD) in PA lumbar spine at 12 months
Secondary	Bone Mineral Density (BMD) in hip at 12 months; bone turnover at 6 and 12 months