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

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
denosumab
teriparatide
Zoledronic acid
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard dose teriparatide

High dose teriparatide

Arm 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

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

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)

Secondary Outcome Measures

Full Information

First Posted
June 25, 2014
Last Updated
January 27, 2021
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02176382
Brief Title
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
Acronym
DATA-HD
Official Title
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard dose teriparatide
Arm Type
Active Comparator
Arm 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
Arm Title
High dose teriparatide
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
denosumab
Other Intervention Name(s)
Prolia
Intervention Description
denosumab subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
teriparatide
Other Intervention Name(s)
Forteo
Intervention Description
teriparatide daily subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Reclast
Intervention Description
zoledronic acid infusion
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)
Time Frame
Baseline and 42 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Leder, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31674641
Citation
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.
Results Reference
background
PubMed Identifier
32790196
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.
Results Reference
background
PubMed Identifier
31447409
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(19)30255-4. Epub 2019 Aug 22.
Results Reference
result

Learn more about this trial

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

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