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NCT02176382 Clinical Trial

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

Postmenopausal Osteoporosis Clinical Trial

— DATA-HD  

Official title:
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02176382
Other study ID # 2014P000853
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 2014
Est. completion date February 2020

Study information
Verified date January 2021
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date February 2020
Est. primary completion date February 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• denosumab
denosumab subcutaneous injection
• teriparatide
teriparatide daily subcutaneous injection
• Zoledronic acid
zoledronic acid infusion

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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). pii: dgz163. doi: 10.1210/clinem/dgz163. — View Citation

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. — View Citation

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( — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA) Baseline and 42 months
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