This is reflected in decreased serum
see more levels of bone formation markers in patients taking GC and, overall, a reduced bone turnover status in subjects with long-term GC treatment [34–36]. The aim of this predefined analysis of the EuroGIOPS trial (clinicaltrials.gov identifier: NCT00503399) was to examine the relationship between BTMs and bone strength estimated by high-resolution QCT (HRQCT)-based FEA at 6 and 18 months of therapy with Torin 2 supplier teriparatide or risedronate in men with GIO. In particular, we determined the correlations between early changes in serum bone turnover markers with subsequent changes in bone strength under different loading conditions. Methods Study design This 18-month, randomized, open-label, controlled study comparing the effects of teriparatide and risedronate in men with GIO was conducted at 16 centres in Germany, Greece, Italy, and Spain. The study design and baseline characteristics of the patients have been reported previously [30, 37]. Briefly, following a screening phase that lasted up to 6 weeks, patients attended a baseline visit at which they were randomized (1:1) to open-label treatment for 18 months with either teriparatide (20 μg once a day as a subcutaneous injection) ISRIB in vitro or risedronate (35 mg once weekly orally as a tablet).
Randomization was stratified by previous bisphosphonate use, and any previous osteoporosis treatment was discontinued during the screening phase before the baseline visit and for the duration of the study. During the study, all but one patient concomitantly received 1 g elemental calcium (as calcium carbonate alone or mixed with calcium lactogluconate), and 800–1,200 IU vitamin D/day. After randomization, patients attended clinic visits at approximately 3, 6, 12, Mannose-binding protein-associated serine protease and 18 months. The study was approved by the responsible institutional
review boards at each centre and was conducted in accordance with the ethical standards of the Declaration of Helsinki and consistent with good clinical practice. Participants The patients enrolled in the study were men aged ≥25 years, ambulatory, with normal laboratory values for serum calcium, alkaline phosphatase, 25-hydroxyvitamin D and parathyroid hormone (PTH). They had a lumbar spine (L1 − L4), femoral neck, or total hip BMD T-score of at least 1.5 standard deviations (SDs) below the corresponding normal young adult men average BMD, and had at least two lumbar vertebrae without artefacts, fractures, or other abnormalities that would interfere with dual X-ray absorptiometry (DXA) or computed tomography (CT) assessments. Patients had received GC therapy at an average dose of at least 5.0 mg/day of prednisone or its equivalent for a minimum of 3 consecutive months immediately preceding the screening visit. Exclusion criteria included unresolved skeletal diseases other than GIO, presence of a spinal fracture in both T12 and L1, impaired renal function (creatinine clearance <30 ml/min/1.