VERTOS-II. Percutaneous Vertebroplasty Versus Conservative Therapy
OsteoporosisBack PainPercutaneous vertebroplasty is a new procedure for treating painful osteoporotic compression fractures of the spine. Five-thousand out of 12.000 patients (16.000 vertebral fractures/year in the Netherlands) present with sudden, severe back pain in the region of the fracture.Until recently, bed rest, analgesia and physical support were the only treatment options. After decades of performing PV, no large RCT with mid-term follow-up has been published. Design: This will be a multicenter (6 centers), prospective, randomised, intervention study. Eligible patients will be randomised for percutaneous vertebroplasty or conservative therapy. Study population: Age: 50 and older, vertebral fracture, level: thoracic vertebral body 5 (Th 5) or lower, osteopenia (T-score < -1 SD), back pain for no more than 6 weeks and edema in the vertebrae on MR imaging Statistical analyses All analyses will be performed on an 'intention to treat' principle. The planned number of subjects will be 200 in total, 100 in each intervention arm. Economic evaluation: Cost-effectiveness will be assessed. The costs of the procedure and the medical treatment, and of visits to medical specialists, GP's and physical therapists will be compared. Time schedule: The total study will take 36 months Recruitment of patients (200) has been completed. In May 2009 the 1 year follow-up will be finished.
Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin...
Postmenopausal OsteoporosisThis is a phase I study to analyze the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in post-menopausal women.
Vitamin D Administration in the Nursing Home
Vitamin D DeficiencyOsteoporosisAdministration of vitamin D 50,000 units once monthly will: Maintain serum 25-OH vitamin D above 20 ng/ml Reduce falls Increase calcaneal BMD Reduce bone turnover Be well tolerated: volunteers will not develop hypercalcemia Improve performance on a swallowing quality of life questionnaire
Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use
OsteoporosisThe purpose of the study is to learn if one year of treatment with parathyroid hormone (PTH), either alone or with risedronate, will increase the thickness of the bones in the hip and spine in subjects with osteoporosis from chronic low dose steroid use. During the second year, the study will also look at whether taking risedronate will preserve the bone thickness created by one year of rhPTH 1-34 treatment.
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Involutional OsteoporosisThe purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.
Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis
Primary OsteoporosisTo evaluate the efficacy and safety of R484iv by intravenous intermittent administration to patients with primary osteoporosis in comparison with sodium risedronate hydrate (RIS) by oral administration every day. To evaluate also the dose response of R484iv.
Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects....
OsteoporosisThis study will evaluate the safety, tolerability and exposure of SB-751689 when administered alone at supratherapeutic doses and when SB-751689 is co administered with ketoconazole, a PGP/CYP3A4 inhibitor that increases exposure of SB-751689. Data from this study will enable the planning and conduct of a QTc study for SB-751689.
Vitamin D Supplementation in Older Women
OsteoporosisAgingThe purpose of this study is to examine the effects of several doses of vitamin D on hormones related to bone, calcium absorption, bone density and muscle strength.
A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide...
OsteoporosisPostmenopausalThe purpose of this study is to use imaging technologies to demonstrate the effects of teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women with osteoporosis.
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous...
Post-Menopausal OsteoporosisThis 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.