Knee OsteoarthritisPhase 2NCT03072147
Teriparatide as a Chondroregenerative Therapy in OA
A Phase 2 study testing Teriparatide in people with Knee Osteoarthritis and Cartilage Degeneration, run by Christopher Ritchlin at 1 site in United States.
Trial summary
The purpose of this study is to evaluate teriparatide (TP) as a chondroregenerative therapy for human knee osteoarthritis (OA). The central hypothesis to be tested is that TP supports structural modification of the joint and improves biomarker, functional and patient-reported measures of knee OA. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Knee Osteoarthritis, Cartilage Degeneration
- What is being tested?
- Teriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Sep 2022
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- male or female 40 to 60 years old.
- radiographic evidence of Kellgren-Lawrence score (K-L score) grade I-II OA in the affected knee
- unilateral symptomatic knee OA
- willingness to forgo potential standard of care treatments (hyaluronic acid and cortisol injections) for knee pain for the duration of the study
- body Mass Index of ≤40
- normal screening vitamin D levels (≥20 and ≤100 mg/ml)
- normal screening serum calcium level (8.5- 10.2 mg/dL)
- a negative screening serum pregnancy test for premenopausal women
Who cannot join
- history of primary hyperparathyroidism disease, hypercalcemia, or persistently abnormal intake PTH levels (≥10 or ≤65 pg/ml)
- history of musculoskeletal malignancy or solid organ carcinoma
- active renal disease defined by a creatinine clearance of <35 or history of kidney stones within the past year
- use of anticonvulsant or digoxin therapy
- inflammatory disease (bowel disease, spondylitis, lupus, fibromyalgia, psoriasis, rheumatoid arthritis, etc)
- current or past treatment with teriparatide
Show all 15Show fewer
- use of immunosuppressants
- severe claustrophobia, retained eye or skull metal fragments, metal hardware in or around the affected knee or other standard contraindications to MRI (cochlear implants, pacemakers)
- dementia, cognitive impairment or other factors that referring provider feels would prevent ability to obtain informed consent and/or follow study protocol
- pregnancy or intent to become pregnant in the two and a half years following enrollment
- women who are currently breastfeeding
- Paget's disease
- osteoporosis diagnosis by DXA in medical history (T-score less than or equal to -2.5)
- reliance on assistive walking devices (canes, walkers, braces, etc.)
- participation in concurrent clinical studies involving investigational medications
Trial locations and contacts
1 site in 1 country.
United States1 site
URMC Orthopaedics, Clinton Crossings Building D
Rochester, New York, 14618
About this study
Official title: Evaluating Teriparatide as a Chondroregenerative Therapy in Human Osteoarthritis
The purpose of this study is to evaluate teriparatide (TP) as a chondroregenerative therapy for human knee osteoarthritis (OA). The central hypothesis to be tested is that TP supports structural modification of the joint and improves biomarker, functional and patient-reported measures of knee OA.
Read the detailed description
This is a prospective, randomized, placebo controlled, double blinded, crossover study. The investigators will identify, recruit and enroll 80 subjects with symptomatic, unilateral medial compartment knee OA. Enrolled subjects will be randomized into equal TP (in the FDA approved form, Forteo) or placebo arms of 40 subjects each (includes allowance for a 25% dropout rate with no replacements). All subjects will be treated for 24 weeks, then followed for an additional 24 weeks to assess the durability of any observed effects. The trial incorporates a crossover design, based on interim analysis of the 24 week outcome data after every subject has completed the 24 week treatment period. If positive effects on structural and/or biomarker measures are apparent from the interim analysis, placebo treated subjects will be offered TP (in the FDA approved form, Forteo) and followed for an additional 24 weeks. If the placebo subjects who choose to participate in the crossover treatment have not yet completed the 48 week visit, it will not occur. These subjects will begin the crossover portion 24 week treatment and monitoring period when they receive the TP pens (in the FDA approved form, Forteo).
- Conditions
- Knee Osteoarthritis, Cartilage Degeneration
- Being tested
- Teriparatide, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Group 1, Forteo
20 mcg of teriparatide injected in thigh or abdomen once a day for 24 weeks.
PlaceboDrug
Also called Group 2
20 mcg of saline injected in thigh or abdomen once a day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Treatment | Active comparator | 20 mcg dosage amounts of teriparatide, in the FDA approved form Forteo, manufactured by Lilly, LLC, are loaded into a 2.4 ml prefilled delivery device (multi injection pen) that administers 28 equal doses as subcutaneous injections in the thigh or abdominal wall. Subjects will inject themselves once a day for 24 weeks. Receives: Drug: Teriparatide |
| Group 2- Placebo | Placebo comparator | Saline placebo is packaged by the manufacturer (Lilly, LLC) in the same 2.4 ml injection pen that is used for teriparatide; it will provide 28 doses of placebo. Subjects will inject themselves once a day for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee MRI
Analysis using Regional Cartilage Volume Segmentation
Measured: Change from Baseline through study completion (baseline, 24 weeks, 48 weeks), an average of one year.
Secondary outcomes (9)
Flexed Knee Radiograph
Interpreted using fractal signature analysis.
Measured: Change from Baseline through study completion (baseline, 24 weeks, 48 weeks), an average of one year.
Urine Biomarker Analysis
Analyzed immediately via enzyme-linked immunosorbent assay (ELISA) to quantify the following biomarker: urinary type II collagen
Measured: Change from Baseline through study completion (baseline, 12 weeks, 24 weeks, 48 weeks), an average of one year.
Serum Biomarker Analysis
Analyzed immediately via enzyme-linked immunosorbent assay (ELISA) to quantify the following biomarker: serum type II collagen degradation neoepitope.
Measured: Change from Baseline through study completion (baseline, 12 weeks, 24 weeks, 48 weeks), an average of one year.
GAITRite
Change in gait pre- and post-treatment analyzed using the GAITRite walking test.
Measured: Change from Baseline through study completion (baseline, 12 weeks, 24 weeks, 48 weeks), an average of one year.
Timed up and go
Change in gait pre- and post-treatment analyzed using the timed-up-and-go (TUG) test.
Measured: Change from Baseline through study completion (baseline, 12 weeks, 24 weeks, 48 weeks), an average of one year.
WOMAC 3.1
The Western Ontario and McMaster Universities Arthritis Index (WOMAC 3.1) measures pre- and post-treatment changes in subjective pain and functionality.
Measured: Change from Baseline through study completion (baseline, 12 weeks, 24 weeks, 48 weeks), an average of one year.
PROMIS Depression
The Depression scale from the Patient-Reported Outcomes Measurement Information System (PROMIS) measures measures subjective changes in mood, pre- and post-treatment.
Measured: Change from Baseline through study completion (baseline, 4 weeks, 12 weeks, 24 weeks, 48 weeks), an average of one year.
PROMIS Pain Interference
The Pain Interference scale from the Patient-Reported Outcomes Measurement Information System (PROMIS) measures subjective changes in pain distress, pre- and post-treatment.
Measured: Change from Baseline through study completion (baseline, 4 weeks, 12 weeks, 24 weeks, 48 weeks), an average of one year.
PROMIS Physical Function
Physical function scale from the Patient-Reported Outcomes Measurement Information System (PROMIS) measures subjective changes in mobility and activities of daily living, pre- and post-treatment.
Measured: Change from Baseline through study completion (baseline, 4 weeks, 12 weeks, 24 weeks, 48 weeks), an average of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start1 May 2017
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, placebo controlled, double blinded study. Interim results will determine if there is a crossover.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Ritchlin
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, University of Rochester, Duke University, Milton S. Hershey Medical Center
- Responsible party
- Sponsor-investigator, Christopher Ritchlin, University of Rochester
- Investigators
- Michael Zuscik, PhD, Principal investigator, University of RochesterEmily Carmody, MD, Principal investigator, University of RochesterChristopher Ritchlin, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072147
- Sponsor's protocol ID
- Forteo 65996
- Status last verified
- May 2023
- First submitted
- 21 Feb 2017
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Teriparatide as a Chondroregenerative Therapy in Human Osteoarthritis
- ClinicalTrials.gov ID
- NCT03072147
- Acronym / sponsor ID
- Forteo 65996
- Conditions
- Knee Osteoarthritis, Cartilage Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Christopher RitchlinUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, University of Rochester, Duke University, Milton S. Hershey Medical Center
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 7 Mar 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 evaluate teriparatide (TP) as a chondroregenerative therapy for human knee osteoarthritis (OA). The central hypothesis to be tested is that TP supports structural modification of the joint and improves biomarker, functional and patient-reported measures of knee OA.
Detailed description
This is a prospective, randomized, placebo controlled, double blinded, crossover study. The investigators will identify, recruit and enroll 80 subjects with symptomatic, unilateral medial compartment knee OA. Enrolled subjects will be randomized into equal TP (in the FDA approved form, Forteo) or placebo arms of 40 subjects each (includes allowance for a 25% dropout rate with no replacements). All subjects will be treated for 24 weeks, then followed for an additional 24 weeks to assess the durability of any observed effects. The trial incorporates a crossover design, based on interim analysis of the 24 week outcome data after every subject has completed the 24 week treatment period. If positive effects on structural and/or biomarker measures are apparent from the interim analysis, placebo treated subjects will be offered TP (in the FDA approved form, Forteo) and followed for an additional 24 weeks. If the placebo subjects who choose to participate in the crossover treatment have not yet completed the 48 week visit, it will not occur. These subjects will begin the crossover portion 24 week treatment and monitoring period when they receive the TP pens (in the FDA approved form, Forteo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, placebo controlled, double blinded study. Interim results will determine if there is a crossover.
| Arm | Type | Receives |
|---|---|---|
| Group 1- Treatment | Active comparator | Drug: Teriparatide20 mcg dosage amounts of teriparatide, in the FDA approved form Forteo, manufactured by Lilly, LLC, are loaded into a 2.4 ml prefilled delivery device (multi injection pen) that administers 28 equal doses as subcutaneous injections in the thigh or abdominal wall. Subjects will inject themselves once a day for 24 weeks. |
| Group 2- Placebo | Placebo comparator | Drug: PlaceboSaline placebo is packaged by the manufacturer (Lilly, LLC) in the same 2.4 ml injection pen that is used for teriparatide; it will provide 28 doses of placebo. Subjects will inject themselves once a day for 24 weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- male or female 40 to 60 years old.
- radiographic evidence of Kellgren-Lawrence score (K-L score) grade I-II OA in the affected knee
- unilateral symptomatic knee OA
- willingness to forgo potential standard of care treatments (hyaluronic acid and cortisol injections) for knee pain for the duration of the study
- body Mass Index of ≤40
Key exclusion criteria (15 listed)
- history of primary hyperparathyroidism disease, hypercalcemia, or persistently abnormal intake PTH levels (≥10 or ≤65 pg/ml)
- history of musculoskeletal malignancy or solid organ carcinoma
- active renal disease defined by a creatinine clearance of <35 or history of kidney stones within the past year
- use of anticonvulsant or digoxin therapy
- inflammatory disease (bowel disease, spondylitis, lupus, fibromyalgia, psoriasis, rheumatoid arthritis, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeriparatideAlso: Group 1, Forteo20 mcg of teriparatide injected in thigh or abdomen once a day for 24 weeks. | Drug | Group 1- Treatment |
| PlaceboAlso: Group 220 mcg of saline injected in thigh or abdomen once a day for 24 weeks. | Drug | Group 2- Placebo |
Primary outcome
Knee MRI
Time frame: Change from Baseline through study completion (baseline, 24 weeks, 48 weeks), an average of one year.
Analysis using Regional Cartilage Volume Segmentation
9 secondary outcomes
Flexed Knee Radiograph
Time frame: Change from Baseline through study completion (baseline, 24 weeks, 48 weeks), an average of one year.
Urine Biomarker Analysis
Time frame: Change from Baseline through study completion (baseline, 12 weeks, 24 weeks, 48 weeks), an average of one year.
Serum Biomarker Analysis
Time frame: Change from Baseline through study completion (baseline, 12 weeks, 24 weeks, 48 weeks), an average of one year.
GAITRite
Time frame: Change from Baseline through study completion (baseline, 12 weeks, 24 weeks, 48 weeks), an average of one year.
Timed up and go
Time frame: Change from Baseline through study completion (baseline, 12 weeks, 24 weeks, 48 weeks), an average of one year.
WOMAC 3.1
Time frame: Change from Baseline through study completion (baseline, 12 weeks, 24 weeks, 48 weeks), an average of one year.
PROMIS Depression
Time frame: Change from Baseline through study completion (baseline, 4 weeks, 12 weeks, 24 weeks, 48 weeks), an average of one year.
PROMIS Pain Interference
Time frame: Change from Baseline through study completion (baseline, 4 weeks, 12 weeks, 24 weeks, 48 weeks), an average of one year.
PROMIS Physical Function
Time frame: Change from Baseline through study completion (baseline, 4 weeks, 12 weeks, 24 weeks, 48 weeks), an average of one year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- 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.
Michael Zuscik, PhD principal investigator
University of Rochester
Emily Carmody, MD principal investigator
University of Rochester
Christopher Ritchlin, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teriparatide in people with Knee Osteoarthritis and Cartilage Degeneration, run by Christopher Ritchlin 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 8 inclusion and 15 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: finished, as of the sponsor's last update on 12 May 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knee MRI (time frame: Change from Baseline through study completion (baseline, 24 weeks, 48 weeks), an average of one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2023.