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Cyclic Versus Daily Teriparatide on Bone Mass

NCT00668941 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2017-08-10

No results posted yet for this study

Summary

Osteoporosis is a disease that affects millions of individuals in the United States and abroad. It leads to decreased bone mass and causes an increased risk of fracture. This study will compare continuous versus cyclic treatment with teriparatide combined with alendronate, another drug for osteoporosis, or teriparatide alone in women with osteoporosis.

Conditions

Interventions

DRUG

Teriparatide

Teriparatide will be given subcutaneously in 20-mcg doses either continuously or cyclically.

DRUG

Alendronate

Participants will take 70 mg per week of alendronate for 48 months.

DIETARY_SUPPLEMENT

Calcium

Calcium supplements will be administered in varied amounts for all participants, but each participant will take enough to bring her total daily calcium intake to 1,200 mg.

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 supplements will be administered in varied amounts for all participants, but each participant will take enough to bring her total daily intake to 1,200 mg.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Health Research, Inc.

    collaborator OTHER

  • Helen Hayes Hospital

    lead OTHER

Principal Investigators

  • Robert Lindsay, MD, PhD · Helen Hayes Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2016-02-29
Completion
2017-11-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00668941 on ClinicalTrials.gov