94 Clinical Trials for Various Conditions
A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).
The objective of this study was to describe persistence with Prolia® 60 mg administered subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months.
The 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.
This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.
The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.
The purpose of this study is to determine how teriparatide or denosumab affects the bone of postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis).
This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.
To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment.
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
The primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and vitamin D alone.
To study the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without existing vertebral fractures.
The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.
This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Effects of Teriparatide in Postmenopausal Women Previously Treated with Alendronate or Raloxifene.
The purpose of this study is to compare treatment with both teriparatide and raloxifene with teriparatide alone. The study will evaluate any side effects that may be associated with the two drugs and may help to determine whether teriparatide and raloxifene together can help patients with osteoporosis more than teriparatide alone.
The purpose of this study is to determine whether the increase in spine bone mineral density that has been generally observed in previous clinical studies involving the study drug can be maintained or even increased if followed with raloxifene HCl. All qualifying study participants will receive the study drug followed by treatment with raloxifene HCl or placebo. All study participants will receive raloxifene HCl in the third phase of the study.
This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab).
The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis
RATIONALE: Zoledronate may reduce bone loss in patients receiving letrozole for breast cancer. PURPOSE: This clinical trial is studying how well zoledronate works in treating osteopenia or osteoporosis in postmenopausal women receiving letrozole for stage I, stage II, or stage IIIA primary breast cancer.
Primary Objective: * To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal. Secondary objectives: * To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining total proximal femur, femoral neck, and trochanter BMD after 1 year of treatment in women who are 0.5-5 years postmenopausal * To assess the general safety of 35-mg risedronate administered once weekly.
To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis. To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption. To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.
The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.
Parathyroid hormone (PTH) increases bone formation and thereby improves bone density and bone strength in postmenopausal women with osteoporosis. However, prolonged PTH treatment increases bone formation less and less over time. This study will test whether increasing the daily dose of PTH sustains its ability to improve bone formation, and optional sub-studies will test several potential reasons why PTH's effects on bone formation decline over time.
This 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.
This is an 18-month, double-blind, placebo-controlled, Phase III trial with a 12-month interim analysis of the effect of ALX1-11, recombinant human parathyroid hormone (1-84) (rhPTH \[1-84\]), on fracture incidence in women with postmenopausal osteoporosis, the TOP study.
The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD) in postmenopausal women with low bone mass.
Bone strength -the main determinant of bone fracture- is a function not only of bone mineral density (BMD) and microstructure, but also of its microenvironment, including bone marrow fat (BMF). The adrenal steroid dehydroepiandrosterone (DHEA) -the main precursor for estrogens and androgens in postmenopausal women- as well as bone-loading exercise, increase BMD in older women, however, their effects on BMF are largely unknown. This study has high potential to unveil the hormonal and mechanical effects of DHEA and exercise on BMF, respectively, and to elucidate longitudinal associations of BMF with bone strength in older women with bone loss.
The purpose of the study is to evaluate the real-world effectiveness and cardiovascular safety of ABL compared with TPTD during the 18-month period after treatment initiation in propensity score (PS)-matched cohorts
This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.