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

NCT02130973 | Unknown Phase 4

• 1 other identifier: AMG 10-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

teriparatide; Forteo; Denosumab; Prolia; bone density; treatment

Outcome Measures

Primary Outcomes (1)

• spine bone density

  3 years

Secondary Outcomes (1)

• bone mineral density of the hip, wrist, total body and lateral spine and CT of arm and leg

  3 years

Other Outcomes (1)

• bone turnover

  3 years

Study Arms (2)

Standard Clinical Practice Regimen

ACTIVE COMPARATOR

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

Experimental (cyclic) regimen

EXPERIMENTAL

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

Interventions

Standard Clinical Practice Regimen DRUG

Standard Clinical Practice Regimen

Also known as: 18 months Forteo followed by 18 months Prolia

Standard Clinical Practice Regimen

Experimental Cyclic Regimen DRUG

Experimental Cyclic Regimen

Also known as: three separate 6 month cycles of daily Forteo, each followed by one of Prolia

Experimental (cyclic) regimen

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Health Research, Inc.: lead

Study Sites (1)

Helen Hayes Hospital

West Haverstraw, New York, 10993, United States

Location

Related Publications (1)

• 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.

  PMID: 31419313 DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Felicia Cosman, M.D.

  Helen Hayes Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 6, 2014
• Study Start: August 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 31, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)