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

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.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

women aged 45+
postmenopausal
osteoporotic with high risk of fracture

Exclusion criteria

no significant previous use of bone health modifying treatments

Treatment and study plan

Denosumab

Drug

denosumab subcutaneous injection

Other names: Prolia

Teriparatide

Drug

teriparatide daily subcutaneous injection

Other names: Forteo

Zoledronic acid

Drug

zoledronic acid infusion

Other names: Reclast

Primary outcomes

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

Time frame: Baseline and 42 months

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: DATA-HD

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2020
First posted: Jun 27, 2014
Registry last updated: Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed