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Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT02130973 (opens ClinicalTrials.gov in a new tab)Other idAMG 10-05
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
60 participants (estimated)
Sponsor
Health Research, Inc. · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Aug 2013
Primary completion
Aug 2018 (estimated)
Completion
Aug 2018 (estimated)
First posted
6 May 2014 (estimated)
Last update posted
31 Aug 2017
Conditions
Osteoporosis

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016201720182019
  1. Ph 4

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

    NCT02130973

    Aug 2013 to est. Aug 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Standard Clinical Practice RegimenDrug
  • Experimental Cyclic RegimenDrug

Arms2

  • 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).

  • 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).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. spine bone density

    Time frame · 3 years

Secondary outcomes(1)

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

    Time frame · 3 years

    Registry description

    Bone mineral density testing of multiple skeletal sites and peripheral QCT with high resolution of the leg and arm

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

11 results

Standard Versus Cyclic Teriparatide and Denosumab Treatment for Osteoporosis: A Randomized Trial.

Cosman et al. 2020Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 16

PMID 31419313DOI 10.1002/jbmr.3850PUB-31419313

Rights unknown11 results
Source linkSee results (11)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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