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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00389740

Enrollment

400

Registered

2006-10-19

Start date

2001-04-02

Completion date

2003-01-16

Last updated

2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Postmenopausal

Brief 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.

Interventions

DRUGMK0217, /Duration of Treatment : 12 Months

DRUGComparator : raloxifene hydrochloride /Duration of Treatment : 12 Months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Bone Mineral Density (BMD) in PA lumbar spine at 12 months	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026