Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal...
Post Menopausal OsteoporosisPost-menopausal osteoporosis and the resulting fractures are an important cause of disability and loss of independence. They also increase the risk of morbidity and mortality. Given potential side effects, hormone replacement therapy is no longer recommended for menopausal women with risk of becoming osteoporotic. The very significant decrease in the use of these treatments is suspected of contributing to a resurgence in the incidence of osteoporotic fractures, particularly in women before the age of 70. There is a need for prevention of osteoporosis.
Lactobacillus Acidophilus and Postmenopausal Osteoporosis Women
Bone LossPost Menopausal Osteoporosis1 moreThis study aims to evaluate the effect of Lactobacillus acidophilus supplementation on calcium status and bone densitometry in postmenopausal women in a randomized, double-blind placebo-controlled study.
DHEA Augmentation of Musculoskeletal Adaptations to Exercise in Older Women
Low Bone MassOsteoporosis1 moreTo determine whether the musculoskeletal adaptations to bone-loading exercise can be significantly augmented in older women (aged 60-85) with low bone mass (osteopenia; T-scores <-1.0 and >-2.5) or moderate osteoporosis (T-scores < -2.5 and >= -3.0) and by restoring serum DHEAS to young adult levels by oral DHEA replacement.
Mechanisms of Anabolic Osteoporosis Therapy
OsteoporosisPostmenopausalThe aim of this study is to investigate the effect of romosozumab on bone cells during early and late phases of treatment.
Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis
OsteoporosisPostmenopausalThis study aims to follow a cohort of osteoporotic patients treated with anti-osteoporotic drugs and to evaluate the impact of these treatments on the osteoporosis-cardiovascular-sarcopenia triad and on pain.
Comparative Efficacy, Safety, PK, and Immunogenicity Study of LY06006 and EU-Prolia in Postmenopausal...
OsteoporosisPostmenopausalthis comparative clinical study is designed to demonstrate that LY06006 and EU-Prolia have no clinically meaningful differences in clinical efficacy, pharmacodynamic (PD), safety, PK, and immunogenicity in postmenopausal women with osteoporosis.
Anabolic Therapy in Postmenopausal Osteoporosis
Postmenopausal OsteoporosisIn this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis...
Postmenopausal OsteoporosisThis study will be conducted to assess the efficacy, pharmacodynamic (PD), safety, tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia® in participants with postmenopausal osteoporosis, in a comparative manner.
Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
OsteoporosisPostmenopausalThis is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, and PK profiles of AVT03 and Prolia in postmenopausal women with osteoporosis. After the screening activities, eligible subjects were randomized in a 1:1 ratio to receive either AVT03 60 mg or Prolia® 60 mg, administered as a subcutaneous (s.c.) injection on Day 1 and Day 180 (Month 6). At Month 12, subjects in AVT03 treatment group will receive a third dose of AVT03 60 mg administered s.c. while subjects in Prolia® treatment group will be re-randomized in a 1:1 ratio to receive either Prolia 60 mg or AVT03 60 mg on Day 365 (Month 12), administered as a subcutaneous injection. Afterwards, the subjects will be followed until the End of Study (EoS) Visit at Month 18 (ie, 6 months after the last dose at Month 12). 32 clinical sites are now participating in this study and total of 532 patients have been randomized. Ccountries : Bulgaria, Czech Republic, Georgia, Poland, South Africa.
Comparative Antiresorptive Efficacy Discontinuation of Denosumab
OsteoporosisPostmenopausal1 moreOsteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene. Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued. This study will help us determine the optimal duration and relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.