DRUG
denosumab
denosumab subcutaneous injection
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
Status
Completed
Phase
Phase 4
Enrollment
76
Locations
1
Results
Posted
Publications
3
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
teriparatide
teriparatide daily subcutaneous injection
DRUG
Zoledronic acid
zoledronic acid infusion
Timeline
From registration to results.
First posted
Jun 27, 2014
Study start
Aug 2014
Primary completion
Feb 2020
Study completion
Feb 2020
Results posted
Jan 22, 2021
Registry updated
Feb 9, 2021
Outcomes
What the study measures.
Primary outcomes
Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)
Time frame · Baseline and 42 months
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 45 Years
- Maximum age
- Not reported
- Sex
- FEMALE
- Healthy volunteers
- Yes
Inclusion Criteria: * women aged 45+ * postmenopausal * osteoporotic with high risk of fracture Exclusion Criteria: * no significant previous use of bone health modifying treatments
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Massachusetts General Hospital
Boston, Massachusetts, United States
Publications
Results and literature.
PMID 31674641 ↗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.PMID 32790196 ↗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.PMID 31447409 ↗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.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.