Influence of ibandronic acid therapy on outcomes of medical rehabilitation of patients with postmenopausal osteoporosis: a prospective open-label randomized controlled trial

Vollständiger Abstract

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INTRODUCTION. Postmenopausal osteoporosis (PMO) is a common metabolic bone disease leading to fractures, reduced quality of life, and disability. Medical rehabilitation improves functional outcomes, but the effect is often unsustainable. Ibandronic acid is an effective antiresorptive agent; however, its role in maintaining rehabilitation benefits remains understudied. AIM. To evaluate the effect of treatment with oral form of ibandronic acid 150 mg on the duration of maintaining the effect of medical rehabilitation in patients with established postmenopausal osteoporosis undergoing the 2nd stage of medical rehabilitation. MATERIALS AND METHODS. The work included 70 women aged 45 years and older in the postmenopausal period of more than 1 year, admitted to hospital for the 2nd stage of medical rehabilitation for diseases of the musculoskeletal system and diagnosed with postmenopausal osteoporosis. Women were randomized into 2 groups: the main group (n = 35), where ibandronic acid, 150 mg tablets for administration once a month, was prescribed, and the comparison group (n = 35). All patients in the main and comparison groups received cholecalciferol (vitamin D3) at an average dose of 1500 IU per day. Evaluation of the effectiveness of treatment after 12 months was carried out using a “battery” of functional tests to assess the function of movement, strength of the muscles of the spine and abdomen, static and dynamic balance indicators, as well as by assessing pain on a 5-point visual analogue scale and quality of life using the SF-36 questionnaire. RESULTS. At 12 months, the main group showed significant improvements in static and dynamic endurance of back and abdominal muscles, walking speed, Timed Up and Go test, postural control (stabilometry), reduction in fall rate (from 34.3 % to 14.3 %; p 0.05), increase in spine BMD (3.5 %) and hip bone mineral density (2.5 %), a 46.6 % decrease in the resorption marker CTx, improvement in SF-36 domains, and pain reduction on VAS (from 4.0 points to 1.5 points; p 0.05). In the comparison group, positive changes were lost by 12 months. Adverse events in the main group occurred in 11.4 % (transient flu-like symptoms). DISCUSSION. Oral bisphosphonate therapy combined with rehabilitation reduces the risk of falls in postmenopausal osteoporosis. CONCLUSION. Twelve-month therapy with oral ibandronic acid (Rezoviva 150 mg once monthly) combined with medical rehabilitation and vitamin D effectively sustains and enhances functional outcomes, increases BMD, reduces pain and falls, and has a favorable safety profile. It is recommended for long-term management of PMO patients after rehabilitation.