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

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: denosumab; Drug: Zoledronic acid; Drug: teriparatide

Study type: Interventional

Funder types: Other

Identifiers

NCT02176382

2014P000853

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• no significant previous use of bone health modifying treatments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Standard dose teriparatide

Active Comparator group

Description:

teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15

Treatment:

Drug: teriparatide

Drug: Zoledronic acid

Drug: denosumab

High dose teriparatide

Active Comparator group

Description:

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

Treatment:

Drug: teriparatide

Drug: Zoledronic acid

Drug: denosumab