A Comparison of PF708 and Forteo in Osteoporosis Patients
OsteoporosisThe purpose of this study is to compare the effects of two teriparatide products, PF708 and Forteo, in patients with osteoporosis.
Effect of VSL#3 on Bone Mineral Density in Postmenopausal Women
Menopausal OsteoporosisOsteoporosis has a devastating impact on quality of life of postmenopausal women, and is a significant cause of disability and morbidity. Many drugs are approved for the prevention and treatment of osteoporosis, but are associated with high costs and side effects. Some data from animal studies suggests that supplementation with probiotics can safely treat and prevent osteoporosis. The probiotic VSL#3 is commercially available, is safe for human consumption, and has been widely used in human clinical trials, and has known health-promoting effects in both children and adults. The double-blind, randomized, placebo-controlled trial of VSL#3 will be conducted for 12 months in 40 postmenopausal women to determine if VSL#3 improves bone mineral density and related bone markers. Study visits will include all or some of the following procedures: a medical exam, urine collection, height and weight measurement, a blood draw to assess bone biomarkers, a DEXA (dual energy X-ray absorptiometry) scan to measure bone density, and health questionnaires. This is one of the first clinical trials proposed to investigate the effects of probiotics in bone in humans. If successful, this proposal will provide the first evidence that nutritional supplementation with the probiotic VSL#3 is a safe and effective strategy for preventing postmenopausal bone loss.
CONFIRM - Study of AGN1 LOEP in Patients With Osteoporosis
OsteoporosisThe study will evaluate the immediate procedure and post-procedure profile of the AGN1 Femoral LOEP™ Kit. All subjects will receive the treatment and be evaluated for any adverse or serious adverse events that could occur during the procedure or immediately post-procedure.
Peri-implant Bone Changes in Post-menopausal Osteoporotic Women
OsteoporosisPostmenopausalThis is a prospective case series study aiming to evaluate the effect of post-menopausal osteoporosis on the jaw bone around dental implants with a modified titanium surface. The study consists of 8 visits that will be performed within a minimum period of 15 months. Participants will be recruited from the Rheumatology Department and Radiology Department at Barts Health National Health Service (NHS) Trust. Participants will include 20 post-menopausal osteoporotic women with a requirement of a tooth to be replaced. The main objective of this study is to radiographically compare alveolar (jaw) bone changes in width and height after the placement of a dental implant with a hydrophilic (SLActive) surface and 12 months after loading (placement of the crown) it in post-menopausal osteoporotic women.
Safety and Tolerability of Intravenous LLP2A-Alendronate for Osteopenia Secondary to Glucocorticoids...
OsteopeniaOsteoporosis1 moreA Phase 1 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women with Osteopenia Secondary to Corticosteroids
PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia...
Postmenopausal OsteoporosisThe purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 individuals.
A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive...
Post Menopausal OsteoporosisThis study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.
Efficacy of Cinacalcet in the Control of Primary Hyperparathyroidism
HyperparathyroidismPrimary1 moreTo assess the efficacy and safety of treatment with cinacalcet and with cinacalcet plus alendronate in controlling bone loss induced by primary hyperparathyroidism.
Kefir on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients
OsteoporosisIn a controlled, parallel, double-blind intervention study over 6 months, the investigators investigated the effects of kefir-fermented milk (1,600 mg/kg) supplemented with calcium bicarbonate (CaCO3, 1,500 mg/kg) and bone metabolism in 40 osteoporosis patients, and compared them with CaCO3 alone without kefir supplements. Bone turnover markers were measured in fasting blood samples collected before therapy and at 1, 3, and 6 months. BMD values at the spine, total hip, and hip femoral neck were assessed by dual-energy x-ray absorptiometry (DXA) at baseline and at 6 months.
Pharmacokinetics of Calcifediol and Cholecalciferol
OsteoporosisThe investigators are intending to perform a clinical study in healthy subjects on the pharmacokinetics of different doses of Hy.D Calcifediol compared to vitamin D3 (cholecalciferol) in order to gain insight into the dose response relationship and to assess kinetic differences including the steady state. The metabolites 1,25(OH)2D, 24,25(OH)2D will be assessed throughout the study to assess the metabolism of vitamin D vs. 25(OH)D. Vitamin D3 will be measured throughout the study to assess compliance with the restriction of exogenous vitamin D supplementation.