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Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

NCT00353080 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2009-12-15

No results posted yet for this study

Summary

To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women

To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption

To confirm general safety of 5 mg daily risedronate as compared to placebo

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DRUG

risedronate (HMR4003)

Sponsors & Collaborators

  • Procter and Gamble

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Välimäki Matti, MD · Division of Endocrinology, Helsinki University Central Hospital, Helsinki, Finland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2005-04-30
Completion
2005-04-30

Countries

  • Finland
  • Netherlands
  • Norway
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00353080 on ClinicalTrials.gov