Center for Musculoskeletal Research
Johns Hopkins University School of Medicine
Multi-center clinical study of PTH for lumbar degenerative disc disease
Lumbar disc disease associated with degeneration of intervertebral disc (IVD) is a leading cause of disability with no disease modifying treatment. Discogenic back pain costs exceed $100 billion annually, including both direct and indirect expenses of treatment. Disc degeneration is almost universal over the age of 50 years, with treatment options including conservative care, steroid injections, prescribed pain medications, and surgery.
We have recently found that parathyroid hormone (PTH) effectively attenuates disc degeneration in aged mice. Our research has identified a novel mechanism of PTH activity in IVD, providing a potential therapeutic target for degenerative disease of lumbar intravertebral disc. Therefore, we hypothesize that three-months of daily teriparatide subcutaneously will improve pain and function and improve lumbar intravertebral disc health in subjects with low back pain secondary to lumbar disc degeneration.
The Hopkins CMR is participating with clinical partners in China to coordinate a multi-center, randomized, double-blind, placebo-controlled clinical trial of the effect of teriparatide for the treatment of lumbar degenerative disc disease. Our clinical partners are The 1st Hospital of Zhong Shan University, Xiang Ya Hospital of Central South University, the General Hospital of Tianjin Medical University, and the 3rd Hospital of Hebei Medical University.
While our clinical partners will recruit and conduct the trial, the researchers at the Hopkins CMR will be responsible for regulatory and scientific oversight. This will include study design, data management, and statistical analysis and interpretation.
The conduct of research at all Chinese sites will be under the approval and oversight of local Chinese IRBs or Ethics Boards. We will maintain documentation of all local IRB/EB approvals required.