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

Phase 4

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: denosumab; Drug: teriparatide; Drug: Zoledronic acid

• Registration Number: NCT02176382
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-27
• Study Start: 2014-08
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Status Verified: 2021-01
• Results First Submitted: 2021-01-01
• Results First Submitted QC: 2021-01-01
• Results First Posted: 2021-01-22
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

• women aged 45+
• postmenopausal
• osteoporotic with high risk of fracture

Exclusion Criteria

• no significant previous use of bone health modifying treatments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose teriparatide	denosumab	teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
Standard dose teriparatide	denosumab	teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
Standard dose teriparatide	teriparatide	teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
High dose teriparatide	teriparatide	teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
Standard dose teriparatide	Zoledronic acid	teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
High dose teriparatide	Zoledronic acid	teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)	Baseline and 42 months

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States