drugset / Trial / NCT02176382
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2014-08
- Primary completion
- 2020-02
- Completion
- 2020-02
Publications
- Background Ramchand SK, David NL, Leder BZ, Tsai JN. Bone Mineral Density Response With Denosumab in Combination With Standard or High-Dose Teriparatide: The DATA-HD RCT. J Clin Endocrinol Metab. 2020 Mar 1;105(3):890-7. doi: 10.1210/clinem/dgz163.
- Background Ramchand SK, David NL, Lee H, Bruce M, Bouxsein ML, Leder BZ, Tsai JN. Effects of Combination Denosumab and High-Dose Teriparatide Administration on Bone Microarchitecture and Estimated Strength: The DATA-HD HR-pQCT Study. J Bone Miner Res. 2021 Jan;36(1):41-51. doi: 10.1002/jbmr.4161. Epub 2020 Sep 19.
- Results Tsai JN, Lee H, David NL, Eastell R, Leder BZ. Combination denosumab and high dose teriparatide for postmenopausal osteoporosis (DATA-HD): a randomised, controlled phase 4 trial. Lancet Diabetes Endocrinol. 2019 Oct;7(10):767-775. doi: 10.1016/S2213-8587(19)30255-4. Epub 2019 Aug 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |
| Comparator | Teriparatide | Protein / enzyme biologic | 20 ug | Subcutaneous |
| Comparator | Teriparatide | Protein / enzyme biologic | 40 ug | Subcutaneous |
| Comparator | Zoledronic acid | Other / unclassified | — | — |