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Osteoporosis, Postmenopausal clinical trials

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NCT ID: NCT06164795 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

Sequential Therapies After Osteoanabolic Treatment

START
Start date: November 25, 2023
Phase:
Study type: Observational

12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics

NCT ID: NCT06079476 Recruiting - Clinical trials for Postmenopausal Osteoporosis

A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.

Start date: October 30, 2023
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to characterize safety and tolerability of romosozumab in postmenopausal women with osteoporosis and a high risk of fracture in India.

NCT ID: NCT05912309 Recruiting - Obesity Clinical Trials

Effects of Time-restricted Eating and Exercise Training on Skeletal Muscle Mass Quantity, Quality and Function in Postmenopausal Women With Overweight and Obesity

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial] is to investigate the effects of a 12-week time restricted eating (TRE) and exercise combined intervention, as compared to (i) TRE alone, and to (ii) Caloric Restriction (CR) plus the same exercise intervention elicited by the TRE group, on Skeletal muscle tissue (SMT) quantity, quality and function (primary outcome), Resting energy expenditure (REE) and cardiometabolic health (secondary outcomes), and miRNA biomarkers in postmenopausal women with overweight or obesity.

NCT ID: NCT05902078 Recruiting - Clinical trials for Postmenopausal Osteoporosis

Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis

EFFECT
Start date: September 27, 2023
Phase: Phase 4
Study type: Interventional

To investigate the efficacy and safety of eldecalcitol in postmenopausal women with low bone mineral density (BMD) or mild osteoporosis through a randomized, open-label, parallel controlled trial with calcitriol as the control.

NCT ID: NCT05688969 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

Mechanisms of Anabolic Osteoporosis Therapy

Start date: June 14, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effect of romosozumab on bone cells during early and late phases of treatment.

NCT ID: NCT05655013 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2)

Start date: May 10, 2023
Phase: Phase 4
Study type: Interventional

The aims of ZOLARMAB2 are fourfold. First, the investigators want to investigate if multiple infusions of zoledronate can prevent the rebound activation of bone turnover and the subsequent bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronate at fixed time-points after the last injection of denosumab or when bone turnover is increased. Second, the investigators want to investigate if bone loss will resume after controlling the rebound activation of bone turnover during the first year after denosumab discontinuation and if this can be prevented by yearly infusions of zoledronate. Third, the investigators want to investigate the underlying pathophysiological mechanisms by investigating biochemical markers, osteoclast and osteoblast activation signals in the bone and bone marrow, and the pool of preosteoclasts/mature osteoclasts before and after treatment with zoledronate. Fourth, the investigators want to investigate the effect of denosumab discontinuation on muscle mass and muscle strength and on insulin sensitivity.

NCT ID: NCT05630768 Recruiting - Clinical trials for Postmenopausal Osteoporosis

Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women

Start date: January 3, 2023
Phase: Phase 4
Study type: Interventional

To evaluate the effect of 1 year of risedronate treatment on the prevention of bone loss after denosumab discontinuation in denosumab-treated post-menopausal osteoporosis for a year

NCT ID: NCT05575167 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

EURODEC
Start date: November 28, 2023
Phase:
Study type: Observational

A 24-month prospective, open-label, randomized, multicenter, multinational, non-inferiority pragmatic clinical trial evaluating zoledronate single or double infusion versus oral alendronate following denosumab

NCT ID: NCT05571514 Recruiting - Clinical trials for Post Menopausal Osteoporosis

Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis

NUTRANACRE
Start date: May 12, 2023
Phase: N/A
Study type: Interventional

Post-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.

NCT ID: NCT05493761 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease

OsteoNAFLD
Start date: December 23, 2022
Phase: Phase 4
Study type: Interventional

Nonalcoholic fatty liver disease (NAFLD) is a chronic, metabolic liver disease that is closely related to obesity, type 2 diabetes mellitus (T2DM) and metabolic syndrome (MetS) in a bidirectional mode. NAFLD affects approximately 25% of the worldwide population. NAFLD refers to a phenotypic spectrum, including steatosis, inflammation and fibrosis, which can lead to cirrhosis and hepatocellular carcinoma in a minority of patients. However, despite its high prevalence, morbidity and mortality, as well as the extensive research in the field, there is not to-date a licensed medication specifically for NAFLD. Emerging evidence supports a potential association between NAFLD and osteoporosis; the prevalence of osteoporosis is probably higher in patients with NAFLD and, vise versa, the prevalence of NAFLD may be higher in patients with osteoporosis. In this context, it has been proposed that certain medications for osteoporosis may also prove to be beneficial to NAFLD. Denosumab, a human monoclonal IgG2 antibody against the receptor activator of nuclear factor kappa-B (NF-κB) ligand (RANKL), is currently an established treatment for osteoporosis and other metabolic bone diseases. The axis RANKL-receptor activator of nuclear factor NF-κB (RANK)-osteoprotegerin (OPG) has been demonstrated as a key regulator of bone metabolism and, when dysregulated, it contributes to the pathogenesis of osteoporosis and other metabolic bone diseases. Interestingly, experimental studies have shown that circulating and hepatic RANKL may be upregulated in mice with diet-induced NAFLD, rendering RANKL a potential contributor to the pathogenesis of NAFLD, and ideally, a promising pharmacological target. On the other hand, bisphosphonates, another established, first-line treatment for osteoporosis, are expected to have no significant effect on hepatic metabolism in patients with NAFLD due to their pharmacokinetics and mechanism of action. This is a prospective non-randomized study which aims to investigate the comparative effect of denosumab versus bisphosphonates on hepatic steatosis and fibrosis in women with postmenopausal osteoporosis and concomitant NAFLD.