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

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ClinicalTrials.gov Identifier: NCT02176382
Recruitment Status : Active, not recruiting
First Posted : June 27, 2014
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Benjamin Leder, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: denosumab Drug: teriparatide Drug: Zoledronic acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
Study Start Date : August 2014
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: denosumab
denosumab subcutaneous injection
Other Name: Prolia

Drug: teriparatide
teriparatide daily subcutaneous injection
Other Name: Forteo

Drug: Zoledronic acid
zoledronic acid infusion
Other Name: Reclast

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
Drug: denosumab
denosumab subcutaneous injection
Other Name: Prolia

Drug: teriparatide
teriparatide daily subcutaneous injection
Other Name: Forteo

Drug: Zoledronic acid
zoledronic acid infusion
Other Name: Reclast




Primary Outcome Measures :
  1. Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA) [ Time Frame: 42 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no significant previous use of bone health modifying treatments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176382


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Benjamin Leder, MD Massachusetts General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Benjamin Leder, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02176382     History of Changes
Other Study ID Numbers: 2014P000853
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic Acid
Denosumab
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents