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

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ClinicalTrials.gov Identifier: NCT02130973
Recruitment Status : Unknown
Verified August 2017 by Felicia Cosman, M.D., Health Research, Inc..
Recruitment status was:  Active, not recruiting
First Posted : May 6, 2014
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Felicia Cosman, M.D., Health Research, Inc.

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Standard Clinical Practice Regimen Drug: Experimental Cyclic Regimen Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab
Study Start Date : August 2013
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: three separate 6 month cycles of daily Forteo, each followed by one of Prolia




Primary Outcome Measures :
  1. spine bone density [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. bone turnover [ Time Frame: 3 years ]
    Measurement of bone formation and bone resorption



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: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

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): NCT02130973


Locations
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United States, New York
Helen Hayes Hospital
West Haverstraw, New York, United States, 10993
Sponsors and Collaborators
Health Research, Inc.
Investigators
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Principal Investigator: Felicia Cosman, M.D. Helen Hayes Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Felicia Cosman, M.D., Professor of Clinical Medicine, Health Research, Inc.
ClinicalTrials.gov Identifier: NCT02130973    
Other Study ID Numbers: AMG 10-05
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Felicia Cosman, M.D., Health Research, Inc.:
teriparatide
Forteo
Denosumab
Prolia
bone density
treatment
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents