How to define responders in osteoarthritis

in Current Medical Research & Opinion (2013), 29(6), 719-29

Background: Osteoarthritis is a clinical syndrome of failure of the joint accompanied by varying degrees of joint pain, functional limitation, and reduced quality of life due to deterioration of articular ... [more ▼]

Background: Osteoarthritis is a clinical syndrome of failure of the joint accompanied by varying degrees of joint pain, functional limitation, and reduced quality of life due to deterioration of articular cartilage and involvement of other joint structures. Scope: Regulatory agencies require relevant clinical benefit on symptoms and structure modification for registration of a new therapy as a disease-modifying osteoarthritis drug (DMOAD). An international Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and International Osteoporosis Foundation was convened to explore the current burden of osteoarthritis, review current regulatory guidelines for the conduct of clinical trials, and examine the concept of responder analyses for improving drug evaluation in osteoarthritis. Findings: The ESCEO considers that the major challenges in DMOAD development are the absence of a precise definition of the disease, particularly in the early stages, and the lack of consensus on how to detect structural changes and link them to clinically meaningful endpoints. Responder criteria should help identify progression of disease and be clinically meaningful. The ideal criterion should be sensitive to change over time and should predict disease progression and outcomes such as joint replacement. Conclusion: The ESCEO considers that, for knee osteoarthritis, clinical trial data indicate that radiographic joint space narrowing40.5mm over 2 or 3 years might be a reliable surrogate measure for total joint replacement. On-going research using techniques such as magnetic resonance imaging and biochemical markers may allow the identification of these patients earlier in the disease process [less ▲]

Platelet-rich plasma (PRP) to treat chronic upper patellar tendinopathies

in Abstract Book of the 3rd Congress of the ECOSEP (2013, April)

Background: Upper patellar tendinopathies remain often chronic and rebel to a thorough conservative treatment. Moreover, the option of a surgical treatment could be disappointing. New treatments are being ... [more ▼]

Background: Upper patellar tendinopathies remain often chronic and rebel to a thorough conservative treatment. Moreover, the option of a surgical treatment could be disappointing. New treatments are being developed. Injection of PRP is one of these. Platelets contain lot of growth factors which would have the potentiality to enhance the healing process of tendons. Even if in vitro and animal experiments have demonstrated this stimulation of tendon healing process1, clinical series are subject to controversy2. Methods: Twenty patients with chronic upper patellar tendinopathy were enrolled. Assessments ［VAS, clinical examination with an algometer, algofunctional scores (IKDC and VISA-P), functional assessments (isokinetic and Optojump) and imagery (ultrasounds and MRI)］were made before infiltration of PRP, and 6 weeks and 3 months after. The PRP was obtained by an apheresis system (COM.TEC, Fresenius). Six millilitres of PRP were injected without local anaesthetic. One week after infiltration, patients started a 6-week standardised sub-maximal eccentric reeducation. Results: We observed a very significant improvement of the algofunctional status as soon as 6 weeks after the infiltration of PRP, and continued to a lesser extent up to 3 months. During functional evaluation, pain decreased as well, but without significant improvement of performances. No significant improvements in the imagery were observed. Interestingly, patients who had a VAS equal or below 1 after 3 months post-infiltration were younger (24.7 vs 32.2 y.o.). Moreover, these younger patients had a significant increase of the IKDC score (p=0.003), a significant improvement of pain during isokinetic evaluations (p<0.05), and during Optojump assessments (p=0.01). Seventy-five percent of subjects were able to return to sport, even if only half of these patients recovered the same level than before the tendinopathy. Discussion / Conclusions: This study demonstrates that a local infiltration of PRP associated with a submaximal eccentric protocol is efficient to improve symptoms of chronic upper patellar tendinopathies, non-responsive to classical conservative treatments. However, up to now, there is no consensus on the method to prepare the PRP. Indeed, each technique could provide a very different PRP (variations in the platelet concentrations and of the amount of red and white cells). [less ▲]

Nonpharmacological management

in Osteoporosis International (2013, April), 24(Suppl.1), 76

Reproducibility of joint space width assessment when external calibration on the radiograph is missing

in Osteoporosis International (2013, April), 24(Suppl.1), 379

Evaluation of the impact of a 6-month training by whole body vibration on the risk of falls among nursing home residents

in Osteoporosis International (2013, April), 24(Suppl.1), 246-247

Quantitative gait assessment using an accelerometer technology as a predictive tool of falls among nursing home residents: a 6-month prospective study

in Osteoporosis International (2013, April), 24(Suppl.1), 210

Cost-effectiveness of vitamin D and calcium supplementation in the treatment of postmenopausal women

in Osteoporosis International (2013, April), 24(Suppl.1), 198

Health economics in osteoarthritis

in Osteoporosis International (2013, April), 24(Suppl.1), 79-80

Quality of life in sarcopenia and frailty

in Osteoporosis International (2013, April), 24(Suppl.1), 76-77

Safety concerns with the long-term management of osteoporosis

in Expert Opinion on Drug Safety (2013)

Introduction: Postmenopausal osteoporosis is a chronic disease that exerts a significant burden on both individuals and the community. Hence, there is a requirement for long-term treatment to be ... [more ▼]

Introduction: Postmenopausal osteoporosis is a chronic disease that exerts a significant burden on both individuals and the community. Hence, there is a requirement for long-term treatment to be associated with a positive benefit-risk balance. Areas covered: In this descriptive review, the long-term safety of calcitonin, selective estrogen receptor modulators (SERMs), bisphosphonates, denosumab and strontium ranelate was reviewed based on randomized controlled trials of 3 years or longer supplemented by extension study data and data from large, observational studies. Expert opinion: Rare adverse events become apparent with all currently available treatments for osteoporosis with long-term therapy. Due to the rarity of these adverse events and to the worldwide burden of osteoporosis, the benefit- risk balance remains in favor of the beneficial effects of treatment on an outcome rather than the probability of an adverse effect. No single antiosteoporosis agent is appropriate for all patients. Treatment decisions should be made on an individual basis, taking into account the relative benefits and risks in different patient populations. [less ▲]