A Study to Compare the Efficacy of Alendronate With and Without Calcium or Calcium Alone In the Treatment of Osteoporosis in Postmenopausal Women (0217-088)(COMPLETED)

Organon

Status and phase

Completed

Phase 3

Conditions

Osteoporosis, Postmenopausal

Treatments

Drug: MK0217, alendronate sodium / Duration of Treatment : 2 Years

Drug: Comparator : calcium carbonate /Duration of Treatment : 2 Years

Study type

Interventional

Funder types

Industry

Identifiers

NCT00398606

2006_546

0217-088

Details and patient eligibility

About

The purpose of this study is to see how well alendronate and calcium as compared to calcium alone increase bone density in postmenopausal women with osteoporosis

Sex

Female

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

Patient is postmenopausal (or surgically menopausal) for at least 5 years.
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