A5053630610- Bone health and treatments
- Bone health and osteoporosis research
- Bone and Joint Diseases
- Pharmaceutical studies and practices
- Hip and Femur Fractures
- Bone Metabolism and Diseases
- Adolescent and Pediatric Healthcare
- Childhood Cancer Survivors' Quality of Life
- Pregnancy and Medication Impact
- Pediatric Pain Management Techniques
- Child and Adolescent Health
- Health Systems, Economic Evaluations, Quality of Life
- Economic and Financial Impacts of Cancer
- Orthopaedic implants and arthroplasty
- COVID-19 Impact on Reproduction
- Neonatal Respiratory Health Research
- Pregnancy and preeclampsia studies
- Ethics and Legal Issues in Pediatric Healthcare
- Maternal Mental Health During Pregnancy and Postpartum
- Pharmaceutical Economics and Policy
- Cardiac Imaging and Diagnostics
- Medical Imaging and Pathology Studies
- Vitamin D Research Studies
- Cancer Diagnosis and Treatment
- CO2 Reduction Techniques and Catalysts
Tris Pharma (United States)
2011-2024
Novartis (United States)
2009-2023
Novartis (Switzerland)
2010-2022
United States Food and Drug Administration
2022
UCLouvain
2013
Novartis (France)
2010-2011
Abstract Zoledronic acid 5 mg (ZOL) annually for 3 years reduces fracture risk in postmenopausal women with osteoporosis. To investigate long-term effects of ZOL on bone mineral density (BMD) and risk, the Health Outcomes Reduced Incidence Once Yearly–Pivotal Fracture Trial (HORIZON-PFT) was extended to 6 years. In this international, multicenter, double-blind, placebo-controlled extension trial, 1233 who received core study were randomized additional (Z6, n = 616) or placebo (Z3P3, 617)....
A number of recent case reports and series have identified a subgroup atypical fractures the femoral shaft associated with bisphosphonate use. population-based study did not support this association. Such relationship has been examined in randomized trials.
Fractures in men are a major health issue, and data on the antifracture efficacy of therapies for osteoporosis limited. We studied effect zoledronic acid fracture risk among with osteoporosis.
Clinical data suggest concomitant therapy with bisphosphonates and parathyroid hormone (PTH) may blunt the anabolic effect of PTH; rodent models that infrequently administered interact differently. To evaluate effects combination an intravenous infusion zoledronic acid 5 mg daily subcutaneous recombinant human (rh)PTH(1-34) (teriparatide) 20 µg versus either agent alone on bone mineral density (BMD) turnover markers, we conducted a 1-year multicenter, multinational, randomized, partial...
Zoledronic acid (ZOL) has shown beneficial effects on bone turnover and mineral density (BMD) in postmenopausal osteoporosis. This study compared the efficacy safety of a once-yearly i.v. infusion ZOL with weekly oral alendronate (ALN) men In this multicenter, double-blind, active-controlled, parallel-group study, participants (n = 302) were randomized to receive either 5 mg or ALN 70 for 24 months. Changes BMD marker levels assessed. increased at lumbar spine, total hip, femoral neck,...
Abstract Two trials have shown that a single 5-mg infusion of zoledronic acid achieves much higher response rates in Paget disease bone than risedronate. The duration this effect is unknown. We conducted an open follow-up responders from the two (152 originally treated with acid, 115 risedronate) out to 6.5 years without further intervention. Endpoints were times relapse (ie, return serum total alkaline phosphatase activity within 20% pretreatment value) or loss (response = normalization 75%...
To evaluate the efficacy of zoledronic acid in prevention bone loss postmenopausal women with low mass.In this 2-year, randomized, multicenter, double-blind, placebo-controlled study, mass were selected randomly to receive either 5 mg intravenously at randomization and month 12 (zoledronic 2 x mg), only placebo 1 or (placebo). The primary endpoint was percentage change lumbar spine mineral density (BMD) (lumbar BMD) 24 relative baseline.Both regimens significantly increased mean BMD compared...
Annual infusions of zoledronic acid 5 mg over 3 years have been shown to reduce fracture incidence. There is now evidence that the effects a single dose on bone mineral density and turnover last for much more than year. Whether this associated with sustained prevention not known. The objective study was assess incidence after only 1 infusion acid. design included post hoc analysis subgroups subjects from 2 trials, who received infusion. multicenter, randomized controlled trials. A total 1367...
Rare or orphan diseases often are inherited and overwhelmingly affect children. Many of these have no treatments, incurable, a devastating impact on patients their families. Regulatory standards for drug approval rare must ensure that receive safe efficacious treatments. However, regulatory bodies shown flexibility in applying to development diseases, given the unique challenges hinder efficient effective traditional clinical trials, including low patient numbers, limited understanding...
Objectives To assess the efficacy of once-yearly zoledronic acid (ZOL) 5 mg in increasing bone mineral density (BMD) men with a recent hip fracture participating Health Outcomes and Reduced Incidence Zoledronic Acid Once- Yearly Recurrent Fracture Trial to compare that women from same study. Design Randomized, placebo-controlled, double-blind trial. Setting International multicenter. Participants Five hundred eight 1,619 within 90 days surgical repair low-trauma study (for comparison)....