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TOP: Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis

NCT00172081 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2532

Last updated 2021-05-14

No results posted yet for this study

Summary

This is an 18-month, double-blind, placebo-controlled, Phase III trial with a 12-month interim analysis of the effect of ALX1-11, recombinant human parathyroid hormone (1-84) (rhPTH \[1-84\]), on fracture incidence in women with postmenopausal osteoporosis, the TOP study.

Conditions

Interventions

DRUG

placebo

Daily subcutaneous injection with placebo

DRUG

ALX1-11

PTH (1-84) 100 mcg injected subcutaneously into the thigh or abdomen

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-04-27
Primary Completion
2003-11-07
Completion
2003-11-07

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Canada
  • Israel
  • Mexico
  • Romania
  • Russia

Study Locations

More Related Trials

Entities

Drugs
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 NCT00172081 on ClinicalTrials.gov