NCT02176382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 22, 2021

Completed
Last Updated

February 9, 2021

Status Verified

January 1, 2021

Enrollment Period

5.5 years

First QC Date

June 25, 2014

Results QC Date

January 1, 2021

Last Update Submit

January 27, 2021

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

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

    Baseline and 42 months

Study Arms (2)

Standard dose teriparatide

ACTIVE COMPARATOR

teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15

Drug: denosumabDrug: teriparatideDrug: Zoledronic acid

High dose teriparatide

ACTIVE COMPARATOR

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

Drug: denosumabDrug: teriparatideDrug: Zoledronic acid

Interventions

denosumabDRUG

denosumab subcutaneous injection

Also known as: Prolia
High dose teriparatideStandard dose teriparatide
teriparatideDRUG

teriparatide daily subcutaneous injection

Also known as: Forteo
High dose teriparatideStandard dose teriparatide
Zoledronic acidDRUG

zoledronic acid infusion

Also known as: Reclast
High dose teriparatideStandard dose teriparatide

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women aged 45+
  • postmenopausal
  • osteoporotic with high risk of fracture

You may not qualify if:

  • no significant previous use of bone health modifying treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related 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):890-7. doi: 10.1210/clinem/dgz163.

    PMID: 31674641BACKGROUND

  • 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: 32790196BACKGROUND

  • 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.

    PMID: 31447409RESULT

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

DenosumabTeriparatideZoledronic Acid

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsParathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Joy Tsai
Organization
Massachusetts General Hospital
jntsai@mgh.harvard.edu
6177266723

Study Officials

  • Benjamin Leder, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2014

First Posted

June 27, 2014

Study Start

August 1, 2014

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

February 9, 2021

Results First Posted

January 22, 2021

Record last verified: 2021-01

Locations

US(1)