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

Massachusetts General Hospital76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postmenopausal Osteoporosis

Interventions

denosumabDRUG

denosumab subcutaneous injection

teriparatideDRUG

teriparatide daily subcutaneous injection

Zoledronic acidDRUG

zoledronic acid infusion

Eligibility

Sex: FEMALEMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * women aged 45+ * postmenopausal * osteoporotic with high risk of fracture Exclusion Criteria: * no significant previous use of bone health modifying treatments

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)

Time frame: Baseline and 42 months

Data from ClinicalTrials.gov

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