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

Primary Purpose

Osteoporosis

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Standard Clinical Practice Regimen
Experimental Cyclic Regimen
Sponsored by
Health Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring teriparatide, Forteo, Denosumab, Prolia, bone density, treatment

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Helen Hayes Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Clinical Practice Regimen

Experimental (cyclic) regimen

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

spine bone density

Secondary Outcome Measures

bone mineral density of the hip, wrist, total body and lateral spine and CT of arm and leg
Bone mineral density testing of multiple skeletal sites and peripheral QCT with high resolution of the leg and arm

Full Information

First Posted
May 2, 2014
Last Updated
August 30, 2017
Sponsor
Health Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02130973
Brief Title
The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab
Official Title
The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Research, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
teriparatide, Forteo, Denosumab, Prolia, bone density, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Clinical Practice Regimen
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Experimental (cyclic) regimen
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Standard Clinical Practice Regimen
Other Intervention Name(s)
18 months Forteo followed by 18 months Prolia
Intervention Description
Standard Clinical Practice Regimen
Intervention Type
Drug
Intervention Name(s)
Experimental Cyclic Regimen
Other Intervention Name(s)
three separate 6 month cycles of daily Forteo, each followed by one of Prolia
Intervention Description
Experimental Cyclic Regimen
Primary Outcome Measure Information:
Title
spine bone density
Time Frame
3 years
Secondary Outcome Measure Information:
Title
bone mineral density of the hip, wrist, total body and lateral spine and CT of arm and leg
Description
Bone mineral density testing of multiple skeletal sites and peripheral QCT with high resolution of the leg and arm
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
bone turnover
Description
Measurement of bone formation and bone resorption
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felicia Cosman, M.D.
Organizational Affiliation
Helen Hayes Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helen Hayes Hospital
City
West Haverstraw
State/Province
New York
ZIP/Postal Code
10993
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31419313
Citation
Cosman F, McMahon D, Dempster D, Nieves JW. Standard Versus Cyclic Teriparatide and Denosumab Treatment for Osteoporosis: A Randomized Trial. J Bone Miner Res. 2020 Feb;35(2):219-225. doi: 10.1002/jbmr.3850. Epub 2019 Oct 23.
Results Reference
derived

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

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