The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab

August 30, 2017 updated by: Felicia Cosman, M.D., Health Research, Inc.
This is a three-year study to evaluate the effect of sequential therapy of Forteo (teriparatide) and denosumab on bone density at the spine, hip, leg and forearm.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In order to maximize the early anabolic effect with teriparatide (TPTD), and to avoid the development of tachyphylaxis to the continued daily administration of TPTD beyond 6 months, cyclic therapy might be optimal. Since Denosumab (Prolia) is a potent antiresorptive agent with a rapid off-effect, it might be the optimal agent to help maximize bone gains with cyclic TPTD/antiresorptive therapy. Our primary hypothesis is that the increment in bone density of the spine by DXA will be greater in women randomized to receive the cyclic sequential regimen (three separate 6 month cycles of daily subcutaneous TPTD, each followed by one subcutaneous injection of Denosumab) compared with daily sequential therapy (18 months of daily subcutaneous TPTD followed by Denosumab therapy for 18 months).

Study Type

Interventional

Enrollment (Anticipated)

60

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
    • New York
      • West Haverstraw, New York, United States, 10993
        • Helen Hayes 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:Subjects should be postmenopausal >age 45, and of any racial origin. They must not be on any osteoporosis medication. They should be willing to participate for the duration of the study and have no physical or psychological illness that would prohibit them from participating. Pregnant women, protected individuals (institutionalized), and those unable to give informed consent will not be recruited. Exclusion criteria are detailed below.

Subjects who meet initial pre-screening criteria will present for an on site screening visit and have a full medical history, brief physical exam, BMD and lab evaluation to confirm eligibility. Osteoporosis will be defined by DXA BMD T-Score < -2.5 at lumbar spine (at least 2 evaluable vertebrae between L1 and L4), or total hip or femoral neck. In addition, women with confirmed vertebral deformity on radiograph or lateral DXA image, or prior osteoporosis-related fracture at age >45 along with a DXA BMD T-Score < -1.5 at one or more skeletal sites will be eligible to participate.

Exclusion Criteria:

  • The use of drugs known to affect skeletal or calcium homeostasis.
  • Multiple vertebral fractures or severe lumbar degenerative changes with fewer than 2 evaluable lumbar vertebrae

  • Current use of anti-resorptive medicines

    • Use of Hormone/Estrogen Therapy, raloxifene or calcitonin within the past 3 months
    • Use of oral bisphosphonate for more than 4 months within the past 2 years or more than 5 years total cumulative bisphosphonate use in the past 10 years
    • Use of intravenous ibandronate within the past 18 months
    • Use of intravenous zoledronic acid within the past 4 years
    • A history of a symptomatic renal stone within the past 3 years or history of multiple symptomatic renal stones
    • Skeletal Disorders other than osteoporosis including: Hypercalcemia, hyperparathyroidism, Paget's Disease or osteomalacia
    • Untreated or uncontrolled thyroid disease
    • Elevated Bone Specific Alkaline Phosphatase level
    • History of external or internal radiation therapy
    • Renal insufficiency with estimated GFR below 30 ml/min
    • Liver function tests (ALT/AST) more than 1.5 times the upper limit of normal
    • Clinically significant hyperuricemia or active gout
    • Any contraindications to receipt of Teriparatide or Denosumab (including hypocalcemia)
    • History of an atypical fracture of the femoral shaft

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: Standard Clinical Practice Regimen
Standard Clinical Practice (Daily) Regimen: 18 months of daily subcutaneous Forteo followed by denosumab therapy for 18 months (18 months of Forteo then 3 injections of Prolia at 18, 24 and 30 months).
Drug: Standard Clinical Practice Regimen
Standard Clinical Practice Regimen
Other Names:
  • 18 months Forteo followed by 18 months Prolia
Experimental: Experimental (cyclic) regimen
Experimental (Cyclic) Regimen: three separate 6-month cycles of daily subcutaneous Forteo, each followed by one subcutaneous injection of Prolia (Forteo from 0 to 6 months, and then from 12 to 18 months and then from 24 to 30 months, for a total dose of 18 months; 3 injections of Prolia at 6, 18 and 30 months).
Drug: Experimental Cyclic Regimen
Experimental Cyclic Regimen
Other Names:
  • three separate 6 month cycles of daily Forteo, each followed by one of Prolia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
spine bone density
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone mineral density of the hip, wrist, total body and lateral spine and CT of arm and leg
Time Frame: 3 years
Bone mineral density testing of multiple skeletal sites and peripheral QCT with high resolution of the leg and arm
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone turnover
Time Frame: 3 years
Measurement of bone formation and bone resorption
3 years

Collaborators and Investigators

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

Sponsor

Health Research, Inc.

Investigators

  • Principal Investigator: Felicia Cosman, M.D., Helen Hayes 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

August 1, 2013

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

May 2, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Actual)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMG 10-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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