Phase 4
Completed N=76
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
Source: ClinicalTrials.gov NCT02176382 ↗Enrolled (actual)
76
Serious AEs
14.5%
Results posted
Jan 2021
Primary outcomePrimary: Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA) — 7.69; 12.70 percent change in BMD
◆ Published Evidence
Established
69citations · ~10 / year
Combination denosumab and high dose teriparatide for postmenopausal osteoporosis (DATA-HD): a randomised, controlled phase 4 trial.
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.
Linked Publications
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Combination denosumab and high dose teriparatide for postmenopausal osteoporosis (DATA-HD): a randomised, controlled phase 4 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA) |
7.69; 12.70 | — |
Eligibility Criteria
Inclusion Criteria
- women aged 45+
- postmenopausal
- osteoporotic with high risk of fracture
Exclusion Criteria
- no significant previous use of bone health modifying treatments
Data sourced from ClinicalTrials.gov (NCT02176382) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.