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Trial · Observational

WithdrawnPhase not statedRegistry data

Knee Osteoarthritis Outcome Measures in Arthritic Patients With Osteoporosis

NCTNCT03217513 (opens ClinicalTrials.gov in a new tab)Other idSTUDY00004918
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase not stated
Enrollment
0 participants (actual)
Sponsor
Edward Fox · Other
Design
Not stated
Countries
1 country

United States

Start
1 Jan 2020 (estimated)
Primary completion
31 Dec 2023 (estimated)
Completion
31 Dec 2024 (estimated)
First posted
14 Jul 2017
Last update posted
24 Oct 2019
Conditions
Osteoporosis · Knee Osteoarthritis

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022202320242025
  1. Ph –

    Knee Osteoarthritis Outcome Measures in Arthritic Patients With Osteoporosis

    NCT03217513

    est. 1 Jan 2020 to est. 31 Dec 2024

    Withdrawn

Registry summary

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

The purpose of this study is to generate proof of concept human data by evaluating osteoarthritis outcome measures in arthritic patients that are prescribed Forteo® as the standard of care to treat their primary diagnosis of osteoporosis.

Arms2

  • Other

    Forteo

    teriparatide 20-microgram once daily available in a 2.4-mL delivery device for subcutaneous injection by the patient

  • Other

    Prolia

    denosumab 60 mg administered as a single subcutaneous injection every 6 months by the health care provider

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Blood levels

    Time frame · 2 years

    Registry description

    Type II collagen degradation neoepitope and C-propeptide

Secondary outcomes(3)

  1. Urine levels

    Time frame · 2 years

    Registry description

    Type II collagen C-telopeptide

  2. Physical function

    Time frame · 2 years

    Registry description

    Timed-Up-And-Go

  3. Patient reported outcomes

    Time frame · 2 years

    Registry description

    PROMIS SF v1.0-Physical Function 12a

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

PubMed tag: none · 2011

8 results

Teriparatide as a chondroregenerative therapy for injury-induced osteoarthritis.

Sampson et al. 2011Science translational medicinecited by 140

PMID 21937758PMC3208271DOI 10.1126/scitranslmed.3002214PUB-21937758

Rights unknown8 results
Source linkSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
INCLUSION CRITERIA: * Age: 40-80 years (inclusive) * Gender: male or female (non-pregnant) * Fluent in written and spoken English * Patients capable of giving informed consent * Primary diagnosis of osteoporosis that will be treated with either Forteo® to induce bone anabolism or Prolia® by the study investigator as part of patient's standard of care treatment * Symptomatic, medial compartment knee OA with a Kellgren-Lawrence (K-L) score between II-III (documented in the medical record by previously collected knee series radiography). Radiographs to be performed within past two years. EXCLUSION CRITERIA: * Age \< 40 or \>80 years * Cognitive impairment * Pregnancy * Non-English speaking persons * History of hyperparathyroidism, hypercalcemia, current/recent renal stones, or malignancy * Depression (currently taking home medication) * History of inflammatory disease (colitis, rheumatoid arthritis, psoriasis, lupus, scleroderma, spondylitis) * Use of immunosuppressants, chemotherapy, or radiotherapy * BMI, angular deformity and K-L score of the contralateral knee (if the OA is bilateral) will be noted as covariates

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