NCT03072147

Teriparatide as a Chondroregenerative Therapy in OA

Evaluating Teriparatide as a Chondroregenerative Therapy in Human Osteoarthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Christopher Ritchlin · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Teriparatide	20 mcg of teriparatide injected in thigh or abdomen once a day for 24 weeks.
DRUG	Placebo	20 mcg of saline injected in thigh or abdomen once a day for 24 weeks.

Timeline

• Start date: 2017-05-01
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2017-03-07
• Last updated: 2023-05-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study