This trial is evaluating whether Palovarotene will improve 1 primary outcome and 12 secondary outcomes in patients with Myositis Ossificans. Measurement will happen over the course of Every six months up to three years.
This trial requires 87 total participants across 1 different treatment group
This trial involves a single treatment. Palovarotene is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.
"Myositis ossificans must be differentiated from Myophtosis and should be treated by an orthopaedic surgeon. Myositis ossificans occurs in an adult following trauma to the arm and presents as an ossified lump in the muscles. There are different forms of Myositis Ossificans. In myositis ossificans progress of the tumour can be seen. All orthopaedic surgeons must be aware of this process and have experience of it as early diagnosis is essential." - Anonymous Online Contributor
"MOS involves the upper limb. It may develop quickly in cases with recent fractures in the proximal humerus. The condition is characterised by pain, swelling and weakness. There is normally remodelling in the affected area as the condition resolves but the presence of inflammation is typically indicated by raised levels of the enzyme CK. If this is not the case then a skeletal biopsy to look for muscle fibrosis and infiltrate is required to make the diagnosis. When myositis ossificans develops in the upper limb this should raise the possibility of metastasis. There may be an underlying condition such as metastatic breast tumour but this is not always the case." - Anonymous Online Contributor
"Myositis ossificans cannot be cured. In this subacute disorder, treatment should be directed at reducing inflammation and accelerating healing. Early initiation of antirheumatic drugs in addition to physical therapy and occupational therapy may help." - Anonymous Online Contributor
"No effective treatments have been found for MOS, except some treatments for soft tissue tumors. Most treatments are surgical, and therefore the results are unclear at present. The use of steroids or radiotherapy, which have been investigated in this situation, is currently considered to be risky. There is a need for a large-scale, randomized, and controlled trial of treatment for patients with MOS." - Anonymous Online Contributor
"About 18,000 people are diagnosed with MO in a year the United States. However, the true numbers are likely much higher. MO is more common in males and in black and white patients." - Anonymous Online Contributor
"This case highlights the challenge we face in diagnosing skeletal myositis ossificans, and has implications for the use of current diagnostic criteria when assessing individuals with chronic inflammatory myopathies such as polymyositis and dermatomyositis." - Anonymous Online Contributor
"Palovarotene significantly improved quality of life and muscular strength of both hands and legs for patients with MIO. The findings of this pilot study validate the use of palovarotene for treatment of skeletal pain in MIO." - Anonymous Online Contributor
"Only one previous study evaluated the effects of a Palovarotene analogue: "Palovar" (Eligard, C.R. Pharmaceuticals, Inc.) as monotherapy in patients with metastatic [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer). Based on this single-arm multicenter, sequential trial, Palovar did not demonstrate any antitumor impact. summary: Results from a recent paper is evaluating whether a substance that resembles vitamin A may help in two different cancers." - Anonymous Online Contributor
"A new formulation of 1.2 mg palovarotene is well tolerated, is absorbed well, and is much more convenient for use as a therapy for myositis ossificans. Palovarotene appears to produce better clinical results when administered at 2 mg twice a day rather than at 1.2 mg daily." - Anonymous Online Contributor
"Patients with MIO have a poor prognosis and must therefore be treated cautiously in observational cohorts and RCTs. Patients with limited evidence regarding treatment and limited evidence of disease in the upper extremities may receive greater benefit with clinical trial-based care." - Anonymous Online Contributor
"Palovarotene induces apoptosis in myoblast cells through p53 upregulation. This observation provides an insight into an alternative mode of action by which palovarotene could be therapeutically beneficial in the treatment of muscular dystrophy." - Anonymous Online Contributor
"In patients with early-stage myositis ossificans, palovarotene produced a shorter time to pain resolution and was as effective as a placebo. The risk of discontinuation, however, in both the palovarotene and placebo arms was the same." - Anonymous Online Contributor