Teriparatide as a Chondroregenerative Therapy in OA

What Was Tested

The trial (phase 2) is built around Teriparatide for osteoarthritis, cartilage loss & avoiding joint replacement.

The purpose of this study is to evaluate teriparatide (TP) as a chondroregenerative therapy for human knee osteoarthritis (OA).

It had two arms (groups): Group 1- Treatment (active comparator) and Group 2- Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

The registry lists 76 actual participants took part.

It was open to people of any sex aged from 40 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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.

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the osteoarthritis, cartilage loss & avoiding joint replacement participants stayed in one arm throughout.

Blinding on both sides kept the osteoarthritis, cartilage loss & avoiding joint replacement participants and researchers unaware of who received Teriparatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-05-01 with completion listed for 2022-09-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Knee MRI (time frame: Change from Baseline through study completion (baseline, 24 weeks, 48 weeks), an average of one year).

It also tracked 9 secondary outcomes, for example Flexed Knee Radiograph, Urine Biomarker Analysis, Serum Biomarker Analysis, GAITRite, Timed up and go and WOMAC 3.1.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 76 people with osteoarthritis, cartilage loss & avoiding joint replacement.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, Osteoarthritis, cartilage loss & avoiding joint replacement research.