Teriparatide as a Chondroregenerative Therapy in OA

NCT03072147 | Completed Phase 2 FDA Drug

• 1 other identifier: Forteo 65996
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis; Cartilage Degeneration

Outcome Measures

Primary Outcomes (1)

• Knee MRI

  Analysis using Regional Cartilage Volume Segmentation

  Change from Baseline through study completion (baseline, 24 weeks, 48 weeks), an average of one year.

Secondary Outcomes (9)

• Flexed Knee Radiograph

  Change from Baseline through study completion (baseline, 24 weeks, 48 weeks), an average of one year.

• Urine Biomarker Analysis

  Change from Baseline through study completion (baseline, 12 weeks, 24 weeks, 48 weeks), an average of one year.

• Serum Biomarker Analysis

  Change from Baseline through study completion (baseline, 12 weeks, 24 weeks, 48 weeks), an average of one year.

• GAITRite

  Change from Baseline through study completion (baseline, 12 weeks, 24 weeks, 48 weeks), an average of one year.

• Timed up and go

  Change from Baseline through study completion (baseline, 12 weeks, 24 weeks, 48 weeks), an average of one year.

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Teriparatide DRUG

20 mcg of teriparatide injected in thigh or abdomen once a day for 24 weeks.

Also known as: Group 1, Forteo

Group 1- Treatment

Placebo DRUG

20 mcg of saline injected in thigh or abdomen once a day for 24 weeks.

Also known as: Group 2

Group 2- Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Christopher Ritchlin: lead
• Eli Lilly and Company: collaborator
• University of Rochester: collaborator
• Duke University: collaborator
• Milton S. Hershey Medical Center: collaborator

Study Sites (1)

URMC Orthopaedics, Clinton Crossings Building D

Rochester, New York, 14618, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Michael Zuscik, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Emily Carmody, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Christopher Ritchlin, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researchers, providers, and subjects will be blinded to treatment group so that outcomes will not be influenced by expectations about the experimental treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This is a prospective, randomized, placebo controlled, double blinded study. Interim results will determine if there is a crossover.

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 7, 2017
• Study Start: May 1, 2017
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)