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Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

NCT02176382 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2021-02-09

Study results available
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Summary

The aim of the study is to assess the effect of an antiresorptive medication in combination with standard dose or alternate dose teriparatide. The study extension will evaluate the effect of one-dose of zoledronic acid after the teriparatide/denosumab combination.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

denosumab

denosumab subcutaneous injection

DRUG

teriparatide

teriparatide daily subcutaneous injection

DRUG

Zoledronic acid

zoledronic acid infusion

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Benjamin Leder, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02176382 on ClinicalTrials.gov