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

Organon

Status and phase

Completed

Phase 3

Conditions

Osteoporosis, Postmenopausal

Treatments

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

Drug: MK0217, /Duration of Treatment : 12 Months

Study type

Interventional

Funder types

Industry

Identifiers

NCT00389740

0217-189

2006_537

Details and patient eligibility

About

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.

Enrollment

400 patients

Sex

Female

Ages

40+ years old

Volunteers

No Healthy Volunteers

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