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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Short name DATA-HD

NCTNCT02176382 (opens ClinicalTrials.gov in a new tab)Other id2014P000853
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
76 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Aug 2014
Primary completion
Feb 2020
Completion
Feb 2020
First posted
27 Jun 2014 (estimated)
Last update posted
9 Feb 2021
Conditions
Postmenopausal Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201620182020
  1. Ph 4

    DATA-HD

    NCT02176382

    Aug 2014 to Feb 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • denosumabDrug
  • teriparatideDrug
  • Zoledronic acidDrug

Arms2

  • Active comparator

    Standard dose teriparatide

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

  • Active comparator

    High dose teriparatide

    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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline and 42 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 42 months

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

GroupValue (percent change in BMD)Spread
Standard Dose Teriparatide7.694.66
High Dose Teriparatide12.705.54

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Standard Dose Teriparatideteriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15 denosumab: denosumab subcutaneous injection teriparatide: teriparatide daily subcutaneous injection Zoledronic acid: zoledronic acid infusion0 / 399 / 390 / 39
High Dose Teriparatideteriparatide 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 denosumab: denosumab subcutaneous injection teriparatide: teriparatide daily subcutaneous injection Zoledronic acid: zoledronic acid infusion0 / 372 / 372 / 37

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2021

10 results

Effects of Combination Denosumab and High-Dose Teriparatide Administration on Bone Microarchitecture and Estimated Strength: The DATA-HD HR-pQCT Study.

Ramchand et al. 2021Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 11

PMID 32790196DOI 10.1002/jbmr.4161PUB-32790196

Rights unknown10 results
Source linkSee results (10)

Indexing hint: Randomized controlled trial · 2020

6 results

Bone Mineral Density Response With Denosumab in Combination With Standard or High-Dose Teriparatide: The DATA-HD RCT.

Ramchand et al. 2020The Journal of clinical endocrinology and metabolismcited by 10

PMID 31674641PMC7112977DOI 10.1210/clinem/dgz163PUB-31674641

Rights unknown6 results
Source linkSee results (6)

Indexing hint: Randomized controlled trial · 2019

14 results

Combination denosumab and high dose teriparatide for postmenopausal osteoporosis (DATA-HD): a randomised, controlled phase 4 trial.

Tsai et al. 2019The lancet. Diabetes & endocrinologycited by 56

PMID 31447409PMC6980341DOI 10.1016/s2213-8587(19)30255-4PUB-31447409

Rights unknown14 results
Source linkSee results (14)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * women aged 45+ * postmenopausal * osteoporotic with high risk of fracture Exclusion Criteria: * no significant previous use of bone health modifying treatments

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