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Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis

NCT00532337 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2012-06-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.

Conditions

Interventions

DRUG

ONO-5334

Placebo - 24/mos.

DRUG

ONO-5334

100mg QD /24 months

DRUG

ONO-5334

50mg BID /24 mos.

DRUG

ONO-5334

300mg QD /24 mos.

DRUG

ONO-5334

Alendronate 70mg once weekly / 24 mos

Sponsors & Collaborators

  • Ono Pharma USA Inc

    lead INDUSTRY

Principal Investigators

  • Tomohiro Kuwayama · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-07-31

Countries

  • Netherlands

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Entities

Diseases

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 NCT00532337 on ClinicalTrials.gov