OsteoporosisNCT03217513
Knee Osteoarthritis Outcome Measures in Arthritic Patients With Osteoporosis
An observational study of Osteoporosis and Knee Osteoarthritis, run by Edward Fox at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoporosis, Knee Osteoarthritis
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients that are evaluated, treated, and followed by the study investigator
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Pilot Study to Evaluate Knee Osteoarthritis Outcome Measures in Arthritic Patients Prescribed Forteo or Prolia for Osteoporosis
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.
Read the detailed description
The traditional treatment paradigm for osteoarthritis (OA) involves palliative strategies focused on pain management and joint replacement. The longstanding inability to develop disease-modifying therapies that can rejuvenate joint cartilage is a great unmet need considering that diarthrodial and spinal OA is the most prevalent disease in the US, equal in numbers to the next top 4 disorders combined (heart, pulmonary, mental health and diabetic conditions) (CDC, 2009). Thus, the development of an effective remittive treatment for OA is a vital public health initiative with potential for tremendous impact. Our long-term research objective is to test a radically different strategy for treatment of OA that is based on findings recently published in Science Translational Medicine (Sampson et al., 2011) that identified human parathyroid hormone1-34 (teriparatide) as a chondroregenerative agent in a murine model of OA. Suggesting a parallel effect in human OA, data mined from the NIH-sponsored OA Initiative revealed improved WOMAC knee function scores in arthritic subjects coincidentally prescribed teriparatide (trade name: Forteo®) to treat osteoporosis. These preclinical and human data provide compelling rationale to study Forteo® as a novel OA therapy directed at improving joint structure and function. The central aim of our overall research program is to challenge the paradigm that cartilage loss in OA is irreversible. Thus, our long-term programmatic goal is to test Forteo® as the first and only disease-modifying treatment for OA with potential to rapidly impact clinical care. To achieve this, we have been developing a clinical trial where subjects with medial compartment Kellgren Lawrence (K-L) stage II-III knee OA will receive either Forteo® or Prolia® (a brand of denosumab) for two years. Disease progression will be assessed via structural, biomarker and functional outcomes at various time points out to 24 months post-initiation of therapy. Since Forteo® is a widely used therapeutic in patients with osteoporosis (OP)-related severe bone loss, we propose to examine OA outcomes in OP patients with concomitant knee OA. This pilot study described here that tests the hypothesis that patients with unilateral or bilateral knee OA (Kellgren-Lawrence grade II-III) that are prescribed Forteo® to treat their primary diagnosis of OP will demonstrate improved physical function (Timed-Up-And-Go), improved patient-reported outcomes (PROMIS 12a, v1.0), and increased blood levels in the cartilage anabolic marker type II collagen C-propeptide. Completion of this proposed experimental design would provide critical proof-of-concept preliminary data supporting the use of biomarkers, physical function testing and questionnaire-based functional assessment to study OA in patients.
- Conditions
- Osteoporosis, Knee Osteoarthritis
- Keywords
- osteoporosis, osteoarthritis, knee
- Medical subject headings
- Osteoporosis, Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Forteo | teriparatide 20-microgram once daily available in a 2.4-mL delivery device for subcutaneous injection by the patient | |
| Prolia | denosumab 60 mg administered as a single subcutaneous injection every 6 months by the health care provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels
Type II collagen degradation neoepitope and C-propeptide
Measured: 2 years
Secondary outcomes (3)
Urine levels
Type II collagen C-telopeptide
Measured: 2 years
Physical function
Timed-Up-And-Go
Measured: 2 years
Patient reported outcomes
PROMIS SF v1.0-Physical Function 12a
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Fox
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edward Fox, Milton S. Hershey Medical Center
- Investigators
- Edward J Fox, M.D., Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217513
- Sponsor's protocol ID
- STUDY00004918
- Status last verified
- Oct 2019
- First submitted
- 12 Jul 2017
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aletaha D. From the item to the outcome: the promising prospects of PROMIS. Arthritis Res Ther. 2010;12(1):104. doi: 10.1186/ar2910. Epub 2010 Feb 1.
PubMed 20156319Bischoff-Ferrari HA, Vondechend M, Bellamy N, Theiler R. Validation and patient acceptance of a computer touch screen version of the WOMAC 3.1 osteoarthritis index. Ann Rheum Dis. 2005 Jan;64(1):80-4. doi: 10.1136/ard.2003.019307. Epub 2004 Jul 1.
PubMed 15231508Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009 May 1;58(16):421-6.
PubMed 19407734Fries JF, Krishnan E, Rose M, Lingala B, Bruce B. Improved responsiveness and reduced sample size requirements of PROMIS physical function scales with item response theory. Arthritis Res Ther. 2011;13(5):R147. doi: 10.1186/ar3461. Epub 2011 Sep 14.
PubMed 21914216Sampson ER, Hilton MJ, Tian Y, Chen D, Schwarz EM, Mooney RA, Bukata SV, O'Keefe RJ, Awad H, Puzas JE, Rosier RN, Zuscik MJ. Teriparatide as a chondroregenerative therapy for injury-induced osteoarthritis. Sci Transl Med. 2011 Sep 21;3(101):101ra93. doi: 10.1126/scitranslmed.3002214.
PubMed 21937758Brostrom EW, Esbjornsson AC, von Heideken J, Iversen MD. Gait deviations in individuals with inflammatory joint diseases and osteoarthritis and the usage of three-dimensional gait analysis. Best Pract Res Clin Rheumatol. 2012 Jun;26(3):409-22. doi: 10.1016/j.berh.2012.05.007.
PubMed 22867935Kraus VB, Feng S, Wang S, White S, Ainslie M, Brett A, Holmes A, Charles HC. Trabecular morphometry by fractal signature analysis is a novel marker of osteoarthritis progression. Arthritis Rheum. 2009 Dec;60(12):3711-22. doi: 10.1002/art.25012.
PubMed 19950282Garnero P, Thompson E, Woodworth T, Smolen JS. Rapid and sustained improvement in bone and cartilage turnover markers with the anti-interleukin-6 receptor inhibitor tocilizumab plus methotrexate in rheumatoid arthritis patients with an inadequate response to methotrexate: results from a substudy of the multicenter double-blind, placebo-controlled trial of tocilizumab in inadequate responders to methotrexate alone. Arthritis Rheum. 2010 Jan;62(1):33-43. doi: 10.1002/art.25053.
PubMed 20039425Hashimoto J, Garnero P, van der Heijde D, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Yoshikawa H, Nishimoto N. A combination of biochemical markers of cartilage and bone turnover, radiographic damage and body mass index to predict the progression of joint destruction in patients with rheumatoid arthritis treated with disease-modifying anti-rheumatic drugs. Mod Rheumatol. 2009;19(3):273-82. doi: 10.1007/s10165-009-0170-4. Epub 2009 May 19.
PubMed 19452245Maksymowych WP, Poole AR, Hiebert L, Webb A, Ionescu M, Lobanok T, King L, Davis JC Jr. Etanercept exerts beneficial effects on articular cartilage biomarkers of degradation and turnover in patients with ankylosing spondylitis. J Rheumatol. 2005 Oct;32(10):1911-7.
PubMed 16206346Papuga MO, Beck CA, Kates SL, Schwarz EM, Maloney MD. Validation of GAITRite and PROMIS as high-throughput physical function outcome measures following ACL reconstruction. J Orthop Res. 2014 Jun;32(6):793-801. doi: 10.1002/jor.22591. Epub 2014 Feb 14.
PubMed 24532421Taylor ME, Delbaere K, Mikolaizak AS, Lord SR, Close JC. Gait parameter risk factors for falls under simple and dual task conditions in cognitively impaired older people. Gait Posture. 2013 Jan;37(1):126-30. doi: 10.1016/j.gaitpost.2012.06.024. Epub 2012 Jul 23.
PubMed 22832468Debi R, Mor A, Segal G, Segal O, Agar G, Debbi E, Halperin N, Haim A, Elbaz A. Correlation between single limb support phase and self-evaluation questionnaires in knee osteoarthritis populations. Disabil Rehabil. 2011;33(13-14):1103-9. doi: 10.3109/09638288.2010.520805. Epub 2011 Jan 5.
PubMed 21208029
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Knee Osteoarthritis Outcome Measures in Arthritic Patients Prescribed Forteo or Prolia for Osteoporosis
- ClinicalTrials.gov ID
- NCT03217513
- Acronym / sponsor ID
- STUDY00004918
- Conditions
- Osteoporosis, Knee Osteoarthritis
- Keywords
- osteoporosis, osteoarthritis, knee
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Edward FoxUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The traditional treatment paradigm for osteoarthritis (OA) involves palliative strategies focused on pain management and joint replacement. The longstanding inability to develop disease-modifying therapies that can rejuvenate joint cartilage is a great unmet need considering that diarthrodial and spinal OA is the most prevalent disease in the US, equal in numbers to the next top 4 disorders combined (heart, pulmonary, mental health and diabetic conditions) (CDC, 2009). Thus, the development of an effective remittive treatment for OA is a vital public health initiative with potential for tremendous impact. Our long-term research objective is to test a radically different strategy for treatment of OA that is based on findings recently published in Science Translational Medicine (Sampson et al., 2011) that identified human parathyroid hormone1-34 (teriparatide) as a chondroregenerative agent in a murine model of OA. Suggesting a parallel effect in human OA, data mined from the NIH-sponsored OA Initiative revealed improved WOMAC knee function scores in arthritic subjects coincidentally prescribed teriparatide (trade name: Forteo®) to treat osteoporosis. These preclinical and human data provide compelling rationale to study Forteo® as a novel OA therapy directed at improving joint structure and function. The central aim of our overall research program is to challenge the paradigm that cartilage loss in OA is irreversible. Thus, our long-term programmatic goal is to test Forteo® as the first and only disease-modifying treatment for OA with potential to rapidly impact clinical care. To achieve this, we have been developing a clinical trial where subjects with medial compartment Kellgren Lawrence (K-L) stage II-III knee OA will receive either Forteo® or Prolia® (a brand of denosumab) for two years. Disease progression will be assessed via structural, biomarker and functional outcomes at various time points out to 24 months post-initiation of therapy. Since Forteo® is a widely used therapeutic in patients with osteoporosis (OP)-related severe bone loss, we propose to examine OA outcomes in OP patients with concomitant knee OA. This pilot study described here that tests the hypothesis that patients with unilateral or bilateral knee OA (Kellgren-Lawrence grade II-III) that are prescribed Forteo® to treat their primary diagnosis of OP will demonstrate improved physical function (Timed-Up-And-Go), improved patient-reported outcomes (PROMIS 12a, v1.0), and increased blood levels in the cartilage anabolic marker type II collagen C-propeptide. Completion of this proposed experimental design would provide critical proof-of-concept preliminary data supporting the use of biomarkers, physical function testing and questionnaire-based functional assessment to study OA in patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forteo | – | –teriparatide 20-microgram once daily available in a 2.4-mL delivery device for subcutaneous injection by the patient |
| Prolia | – | –denosumab 60 mg administered as a single subcutaneous injection every 6 months by the health care provider |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients that are evaluated, treated, and followed by the study investigator
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Age < 40 or >80 years
- Cognitive impairment
- Pregnancy
- Non-English speaking persons
- History of hyperparathyroidism, hypercalcemia, current/recent renal stones, or malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood levels
Time frame: 2 years
Type II collagen degradation neoepitope and C-propeptide
3 secondary outcomes
Urine levels
Time frame: 2 years
Physical function
Time frame: 2 years
Patient reported outcomes
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
- Background: PubMed 20156319Aletaha D. From the item to the outcome: the promising prospects of PROMIS. Arthritis Res Ther. 2010;12(1):104. doi: 10.1186/ar2910. Epub 2010 Feb 1.
- Background: PubMed 15231508Bischoff-Ferrari HA, Vondechend M, Bellamy N, Theiler R. Validation and patient acceptance of a computer touch screen version of the WOMAC 3.1 osteoarthritis index. Ann Rheum Dis. 2005 Jan;64(1):80-4. doi: 10.1136/ard.2003.019307. Epub 2004 Jul 1.
- Background: PubMed 19407734Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009 May 1;58(16):421-6.
- Background: PubMed 21914216Fries JF, Krishnan E, Rose M, Lingala B, Bruce B. Improved responsiveness and reduced sample size requirements of PROMIS physical function scales with item response theory. Arthritis Res Ther. 2011;13(5):R147. doi: 10.1186/ar3461. Epub 2011 Sep 14.
- Background: PubMed 21937758Sampson ER, Hilton MJ, Tian Y, Chen D, Schwarz EM, Mooney RA, Bukata SV, O'Keefe RJ, Awad H, Puzas JE, Rosier RN, Zuscik MJ. Teriparatide as a chondroregenerative therapy for injury-induced osteoarthritis. Sci Transl Med. 2011 Sep 21;3(101):101ra93. doi: 10.1126/scitranslmed.3002214.
- Background: PubMed 22867935Brostrom EW, Esbjornsson AC, von Heideken J, Iversen MD. Gait deviations in individuals with inflammatory joint diseases and osteoarthritis and the usage of three-dimensional gait analysis. Best Pract Res Clin Rheumatol. 2012 Jun;26(3):409-22. doi: 10.1016/j.berh.2012.05.007.
- Background: PubMed 19950282Kraus VB, Feng S, Wang S, White S, Ainslie M, Brett A, Holmes A, Charles HC. Trabecular morphometry by fractal signature analysis is a novel marker of osteoarthritis progression. Arthritis Rheum. 2009 Dec;60(12):3711-22. doi: 10.1002/art.25012.
- Background: PubMed 20039425Garnero P, Thompson E, Woodworth T, Smolen JS. Rapid and sustained improvement in bone and cartilage turnover markers with the anti-interleukin-6 receptor inhibitor tocilizumab plus methotrexate in rheumatoid arthritis patients with an inadequate response to methotrexate: results from a substudy of the multicenter double-blind, placebo-controlled trial of tocilizumab in inadequate responders to methotrexate alone. Arthritis Rheum. 2010 Jan;62(1):33-43. doi: 10.1002/art.25053.
- Background: PubMed 19452245Hashimoto J, Garnero P, van der Heijde D, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Yoshikawa H, Nishimoto N. A combination of biochemical markers of cartilage and bone turnover, radiographic damage and body mass index to predict the progression of joint destruction in patients with rheumatoid arthritis treated with disease-modifying anti-rheumatic drugs. Mod Rheumatol. 2009;19(3):273-82. doi: 10.1007/s10165-009-0170-4. Epub 2009 May 19.
- Background: PubMed 16206346Maksymowych WP, Poole AR, Hiebert L, Webb A, Ionescu M, Lobanok T, King L, Davis JC Jr. Etanercept exerts beneficial effects on articular cartilage biomarkers of degradation and turnover in patients with ankylosing spondylitis. J Rheumatol. 2005 Oct;32(10):1911-7.
- Background: PubMed 24532421Papuga MO, Beck CA, Kates SL, Schwarz EM, Maloney MD. Validation of GAITRite and PROMIS as high-throughput physical function outcome measures following ACL reconstruction. J Orthop Res. 2014 Jun;32(6):793-801. doi: 10.1002/jor.22591. Epub 2014 Feb 14.
- Background: PubMed 22832468Taylor ME, Delbaere K, Mikolaizak AS, Lord SR, Close JC. Gait parameter risk factors for falls under simple and dual task conditions in cognitively impaired older people. Gait Posture. 2013 Jan;37(1):126-30. doi: 10.1016/j.gaitpost.2012.06.024. Epub 2012 Jul 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward J Fox, M.D. principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Knee Osteoarthritis, run by Edward Fox at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood levels (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03217513, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.