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Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)

NCT00365456 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2012-08-20

Study results available
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Summary

The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate.

Conditions

Interventions

DRUG

Parathyroid Hormone (PTH)

Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen.

DRUG

Risedronate

Orally once weekly as one 35 mg tablet.

Sponsors & Collaborators

Principal Investigators

  • Nycomed Clinical Trial Operations · Headquaters

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2011-01-31
Completion
2011-08-31

Countries

  • Denmark

Study Locations

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Entities

Diseases
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 NCT00365456 on ClinicalTrials.gov