A large prospective European cohort study of patients treated with strontium ranelate and followed up over 3 years

Abstract

Strontium ranelate has been available as an osteoporosis treatment in Europe since 2004. This article describes a large European observational survey of the use of strontium ranelate in clinical daily practice. A retrospective observational registry included 32,446 women consulting for postmenopausal osteoporosis in seven countries. Within the registry, 12,046 women were receiving strontium ranelate and were followed up over 3 years. The baseline characteristics of the follow-up cohort were similar to those of the whole registry cohort (age, 68.9 ± 10.3 years; body mass index, 25.6 ± 4.3 kg/m(2); lumbar spine T-score, -2.57 ± 0.85 SD; femoral neck T-score, -2.11 ± 0.86 SD). At baseline, 77 % of patients had at least one risk factor for osteoporosis, and 46 % had a previous history of osteoporotic fracture. Mean duration of follow-up was 32.0 ± 9.7 months, and treatment duration was 25.2 ± 13.7 months (24,956 patient-years of treatment). Persistence with strontium ranelate was 80 % at 1 year, 68 % at 2 years, and 64 % at 32 months; most patients (about 80 %) reported rarely omitting a dose. At least one emergent adverse event was reported in 2,674 (22 %) patients, most frequently gastrointestinal side effects. The crude incidence of venous thromboembolic events was 2.1/1,000 patient-years. No cases of hypersensitivity reactions, such as drug rash with eosinophilia and systemic symptoms (DRESS), Steven-Johnson syndrome, or toxic epidermal necrolysis, were reported. During follow-up, a fracture occurred in 890 patients (7 %); 429 of the fractures were nonvertebral fractures. Our observational survey over 32 months indicated good rates of adherence with strontium ranelate and confirmed its good safety profile in the management of postmenopausal osteoporosis.

Cardiac concerns associated with strontium ranelate

“…No specific cardiac concerns were detected by regulatory post-marketing surveillance covering about 3.4 million patient-years of strontium ranelate treatment between September 2004 and September 2012 [8] . A 32-month observational prospective cohort study in 12,046 patients on strontium ranelate, which predates the PSUR, did not report any cardiac safety issues [11] . The mean age of this cohort was 69 years and nearly a third (30%) had hypertension and 16% had dyslipidaemia; rates of uncontrolled hypertension were not recorded.…”

Osteoporosis

“…In humans, strontium ranelate protects against fractures of the spine and likely reduces fractures of the hip as well. [171][172][173][174][175][176][177] The treatment is generally well tolerated with some gastrointestinal side effects (diarrhea) and has been associated with increased risk of thromboembolism for reasons that remain unclear. Strontium ranelate is not FDA approved for use in the United States.…”

The Place of Strontium Ranelate in the Treatment of Patients With Osteoporosis (Results of the Marc Program)

“…Доказательств увеличения числа неблагоприятных исходов со стороны ССС не было получено и по данным проспективного наблюдательного европейского когортного исследования, включавшего 12 076 пациентов, в течение 2 лет принимавших СР. За 32,0±9,7 мес наблюдения было выявлено только 33 случая ИМ, что соответствовало 1,3 на 1000 пациенто-лет [9].…”