Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

February 22, 2017 updated by: Benjamin Leder, MD, Massachusetts General Hospital
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Must satisfy A and B and C below:

A. Women aged 45+

B. Postmenopausal

C. Osteoporotic with high risk of fracture

Exclusion Criteria:

  • History of significant hepatic, renal, cardiovascular, malignant disease, or conditions with impaired immune system
  • Current alcohol or substance abuse
  • Major psychiatric disorders
  • Abnormal calcium level, elevated PTH, vitamin D deficiency, or anemia
  • Known congenital or acquired bone disease other than osteoporosis
  • Current use or past use in the past 12 months of oral bisphosphonates
  • Current use or use in the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin
  • Use of oral or parenteral glucocorticoids for more than 14 days in the past 6 months
  • Any current or previous use of strontium or intravenous bisphosphonates
  • Sensitivity to cell-derived drug products or teriparatide
  • Extensive dental work involving dental extraction or dental implant within the past 2 months or in the upcoming 2 months
  • Inability to sit upright for 30 minutes
  • Esophageal abnormalities

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
Active Comparator: Denosumab 60mg subcutaneous injection
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Drug: Teriparatide 40-mcg subcutaneous injection
Other Names:
  • Forteo®
Drug: Denosumab Injection
One-time Denosumab injection
Active Comparator: Alendronate 70mg weekly x 8 weeks
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Drug: Teriparatide 40-mcg subcutaneous injection
Other Names:
  • Forteo®
Drug: Alendronate Oral Tablet
weekly alendronate for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Turnover Marker (Blood Sample)
Time Frame: 8 weeks
The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.
8 weeks

Collaborators and Investigators

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

Sponsor

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

January 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012P001956

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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