Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis (DATA)

May 30, 2018 updated by: Benjamin Leder, MD, Massachusetts General Hospital

The Denosumab And Teriparatide Administration Study (DATA)

The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one alone in postmenopausal osteoporotic women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Must satisfy A and B and C and D below:

  • (A) Women aged > 55
  • (B) Postmenopausal
  • (C) Osteoporotic with high risk of fracture

Exclusion Criteria:

  • Confirmed serum alkaline phosphatase above upper normal limit with no explanation
  • Liver disease (AST or ALT > 2 x upper normal limit).
  • Renal disease (serum creatinine > 2.0 mg/dl).
  • Hypercalcemia (Ca >10.5 mg/dL)
  • Elevated blood PTH (intact PTH > 65 pg/ml)
  • Serum 25-OH vitamin D < 20 ng/ml
  • HCT < 32%.
  • History of malignancy (except basal cell carcinoma) or radiation therapy.
  • Significant cardiopulmonary disease including unstable coronary artery disease, stage D ACC/AHA heart failure or any other condition that the investigator deems may preclude the subject from participating safely or completing the protocol procedures.
  • Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
  • Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
  • Known congenital or acquired bone disease other than osteoporosis (including osteomalacia, hyperparathyroidism, Paget's disease)
  • Current use or use in the past 6 months of oral bisphosphonate
  • Current use or use within the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin.
  • Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months.
  • Any current or previous use of strontium or any parenteral bisphosphonate.
  • Known sensitivity to mammalian cell-derived drug products.
  • Known sensitivity to teriparatide or any of its excipients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: denosumab ONLY
Drug: denosumab
denosumab: 60 mg SC every 6 months
Experimental: teriparatide (Forteo®) ONLY
Drug: teriparatide
teriparatide: 20 mcg SC QD
Other Names:
  • Forteo®
Experimental: denosumab and teriparatide (Forteo®)
Drug: denosumab
denosumab: 60 mg SC every 6 months
Drug: teriparatide
teriparatide: 20 mcg SC QD
Other Names:
  • Forteo®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Spine Bone Density From Baseline to 2 Years
Time Frame: Baseline and 2 years
Baseline and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Amgen

Investigators

  • Principal Investigator: Benjamin Z Leder, MD, Massachusetts General Hospital
  • Principal Investigator: Robert M Neer, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 19, 2009

First Submitted That Met QC Criteria

June 22, 2009

First Posted (Estimate)

June 23, 2009

Study Record Updates

Last Update Posted (Actual)

June 29, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20080723
  • 2009P000525

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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