A Study to Determine the Patient Preference Between Zosano Pharma Parathyroid Hormone (ZP-PTH) Patch...
Postmenopausal OsteoporosisThe purpose of this study is to determine which of two delivery methods of Parathyroid Hormone (PTH) is preferred by patients after 14 days of use for each.
Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)
Osteoporotic FracturesOsteoporosis1 moreThe goal of this study is to perform the first fracture reduction clinical trial with a potent antiresorptive agent (intravenous zoledronic acid) in the most vulnerable long-term care population.
Preventing Osteoporosis Using Denosumab
OsteoporosisPostmenopausal2 moreThe purpose of this research study is to find out if denosumab (Prolia®), an injection given in the arm under the skin every 6 months, works to treat bone loss and prevent it from worsening in older men and women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
OsteoporosisPostmenopausal9 moreThe objective of this study is to measure the early effects of abaloparatide on tissue-based bone formation using samples obtained by transiliac crest bone biopsy after quadruple fluorochrome labeling.
Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers
Postmenopausal OsteoporosisCMAB807 is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once six months and is approved for various indications, including the treatment of postmenopausal women with osteoporosis at increased/high risk of fracture. This phase 1 clincical study investigates the pharmacokinetics, safety and immnogenicity of CMAB807,compared to prolia®, in healthy Chinese male subjects.
A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal...
Postmenopausal OsteoporosisThe primary objective of this study is to demonstrate equivalent efficacy of FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO). Participants will be randomized at the beginning of the Double-blind Core Treatment Period (Baseline to Week 52) to receive either FKS518 or US-licensed Prolia on Day 1, and then every 26 weeks for up to 52 weeks. At the beginning of the Double-blind Transition Period (Week 52 to Week 78), participants who received US-licensed Prolia will be re-randomized to either continue receiving US-licensed Prolia every 26 weeks for up to 78 weeks, or switch to receive FKS518 every 26 weeks for up to 78 weeks. Participants who were randomized to receive FKS518 at the beginning of the Double-blind Core Treatment Period will continue to receive this treatment during the Double-blind Transition Period. For Marketing Authorization Application (MAA) in the EU and European Economic Area (EEA) only: The primary objective is to demonstrate equivalent efficacy and pharmacodynamics of the proposed biosimilar denosumab FKS518 to US-Prolia in women with PMO.
Prevention of Early Postmenopausal Bone Loss With Lactobacillus Reuteri
Postmenopausal OsteoporosisThis study evaluates the effect of two different doses of Lactobacillus reuteri ATCC PTA 6475 (L.reuteri 6475) on bone loss in early postmenopausal women. One third of the participants will be randomised to the lower dose, one third to the higher dose and one third to placebo.
The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam
Postmenopausal OsteoporosisThis is a multi-center, open-label, drug-drug interaction study in postmenopausal women with osteoporosis.
A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of...
OsteoporosisPostmenopausalThe purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.
Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in...
OsteoporosisPostmenopausal OsteoporosisThe purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.