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A Study to Assess the Safety and Efficacy of 3 Doses of ALX1-11 (50, 75, and 100µg) in the Treatment of Postmenopausal Osteoporosis

NCT00172107 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2021-05-17

No results posted yet for this study

Summary

A double-blind, placebo-controlled, parallel-group study to assess the safety and efficacy of 3 doses of ALX1-11 (recombinant human parathyroid hormone \[rhPTH(1-84)\])(50, 75 and 100 µg) in the treatment of postmenopausal osteoporosis. The primary objective of this study is to compare the efficacy of ALX1-11 (50, 75 and 100 µg) with that of placebo in terms of increasing vertebral bone mineral density, when given daily by subcutaneous injection for 12 months in postmenopausal women with osteoporosis.

Conditions

Interventions

DRUG

ALX1-11 50 mcg

PTH(1-84) 50 mcg for subcutaneous injection into thigh or abdomen

DRUG

placebo

placebo powder for subcutaneous injection

DRUG

ALX1-11 75mcg

PTH(1-84)75 mcg for subcutaneous injection

DRUG

ALX1-11

PTH (1-84) 100mcg for subcutaneous injection into thigh or abdomen

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
1995-05-18
Primary Completion
1997-03-24
Completion
1997-03-24

Countries

  • United States
  • Canada

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 NCT00172107 on ClinicalTrials.gov