Clinical trials: Denosumab, completed
Renal Impairment
Multiple Dose Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg in Adults With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis
The primary objective was to evaluate the incidence of clinically significant hypocalcemia following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic kidney disease (CKD) and CKD on dialysis
- Trial name
- NCT01464931
- Testing
- Denosumab
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Amgen
Breast Cancer Prevention, Mammographic Density
RANKL Inhibition and Breast Tissue Biomarkers
A robust knowledge of how to reduce breast density could play a key role in breast cancer prevention in premenopausal women, but viable preventative targets to reduce breast density-associated breast cancer risk are yet to be…
- Trial name
- NCT03629717
- Testing
- Ultrasound-guided core needle biopsy, Denosumab, Blood draw
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Washington University School of Medicine
Urothelial Carcinoma, Kidney Cancer
Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases
This is a phase 2 study of the drug denosumab for the management bone metastases from urothelial cancer. The purpose of this study is to find out how effective denosumab is in the management of bone metastases from urothelial…
- Conditions
- Urothelial Carcinoma, Kidney Cancer, Ureter Cancer, Bladder Cancer
- Trial name
- NCT03520231
- Testing
- Denosumab, Gemcitabine, Carboplatin
- Where
- Canada
- Volunteers
- 6 people
- Sponsor
- University Health Network, Toronto
Bone Resorption
The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty
This study evaluates the effect of Denosumab in decreasing the periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within a year after surgery.
- Trial name
- NCT02760979
- Testing
- Denosumab
- Volunteers
- 60 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Breast Cancer
Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy
The purpose of this study is to determine whether denosumab compared to placebo, will reduce the rate of first clinical fracture in women with non-metastatic breast cancer receiving (non-steroidal) aromatase inhibitor therapy.
- Trial name
- NCT00556374
- Testing
- Denosumab, Non-steroidal aromatase inhibitor therapy, Zoledronic Acid
- Where
- 46 sites in Austria, Sweden
- Volunteers
- 3,420 people
- Sponsor
- Amgen
Healthy Volunteer
Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product
To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.
- Trial name
- NCT02053753
- Testing
- Denosumab CP4, Denosumab CP2
- Where
- 2 sites in United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Amgen
Steroid-induced Osteopor, Glucocorticoid-induced Ostepor
Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids
This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.
- Trial name
- GIOP (NCT01575873)
- Testing
- Denosumab, Risendronate
- Where
- 99 sites in United States, Argentina and 14 more
- Volunteers
- 795 people
- Sponsor
- Amgen
Osteoporosis
Denosumab Versus Bisphosphonates (Alendronate) in GIOP
A randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis
- Trial name
- NCT03005678
- Testing
- Denosumab, Alendronate
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Tuen Mun Hospital
Osteoporotic Vertebral Compression Fracture
Denosumab and Osteoporotic Vertebral Compression Fracture
This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture…
- Trial name
- NCT05058443
- Testing
- Denosumab 60 mg/ml [Prolia]
- Where
- China
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Shenzhen People's Hospital
Erosive Osteoarthritis
The Use of Steovess/Binosto After Denosumab Discontinuation to Prevent Increase in Bone Turnover
It is hypothesized that effervescent alendronate will be able to maintain bone turnover markers within the pre-menopausal reference range and thereby reducing the likelihood of bone turnover associated changes (rebound effect)…
- Trial name
- NCT04403698
- Testing
- Alendronate Effervescent Oral Tablet
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- University Hospital, Ghent
Osteoporosis, Postmenopausal
A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.
- Trial name
- NCT01495000
- Testing
- denosumab
- Where
- 11 sites in India
- Volunteers
- 250 people
- Sponsor
- GlaxoSmithKline
Infertility, Male
NT-NOA - Novel Treatment of Some Men With Non-Obstructive Azoospermia
This clinical interventional study aims to assess whether treatment with denosumab in combination with letrozole can improve sperm production in infertile men with non-obstructive azoospermia selected by serum anti-mullerian…
- Trial name
- NT-NOA (NCT06706414)
- Testing
- Denosumab (Prolia), Letrozole (Aromatase Inhibitors)
- Where
- Denmark
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Martin Blomberg Jensen
Osteoarthritis, Hip, Ambulation Difficulty
Effects of Denosumab on Periprosthetic Bone After Total Hip Arthroplasty
The primary objective is to study the effect of Denosumab on Bone Mineral Density, Standardised Uptake Value and bone metabolism in patients with total hip arthroplasty.
- Trial name
- NCT01630941
- Testing
- denosumab
- Where
- Sweden
- Volunteers
- 64 people
- Sponsor
- Hans Mallmin
Osteoporosis in Postmenopausal Women
Efficacy and Safety of Combination Denosumab With Eldecalcitol for Postmenopausal Women With Osteoporosis.(ESCORT)
Primary objective: To compare the bone mineral density (BMD) change under the treatment of denosumab with eldecalcitol or native vitamin D in postmenopausal women with osteoporosis on bone mineral density.
- Trial name
- ESCORT (NCT05884372)
- Testing
- Eldecalcitol, Native Vitamin D, Denosumab
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Xi'an Honghui Hospital
Cancer, Hematologic Malignancies
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.
- Conditions
- Cancer, Hematologic Malignancies, Multiple Myeloma, Oncology
- Trial name
- NCT01345019
- Testing
- Denosumab, Zoledronic acid, Denosumab (for the open-label treatment phase)
- Where
- 309 sites in United States, Australia and 27 more
- Volunteers
- 1,718 people
- Sponsor
- Amgen
Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Osteopenia
Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant
This Phase II trial studies the side effects of denosumab and to see how well it works in treating patients with bone loss who have received a donor stem cell transplant.
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Osteopenia, Osteoporosis
- Trial name
- NCT03925532
- Testing
- Denosumab
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Roswell Park Cancer Institute
Postmenopausal Osteoporosis
A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®
The Study will be conducted to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women with Osteoporosis.
- Trial name
- NCT05405725
- Testing
- ENZ215, Prolia
- Where
- 48 sites in Bulgaria, Czechia and 5 more
- Volunteers
- 504 people
- Sponsor
- Enzene Biosciences Ltd.
Sarcopenia, Osteoporosis
Muscle Impact of Treating Osteoporosis
Osteosarcopenia is a geriatric musculoskeletal syndrome characterized by co-existence of osteoporosis and sarcopenia (low skeletal muscle mass, strength, and/or functional capacity).
- Trial name
- MITO (NCT05666310)
- Testing
- Denosumab, Zoledronic Acid
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Nami Safai Haeri
Osteoporosis
Denosumab Adherence Preference Satisfaction Study
The primary objective is to evaluate the adherence of subjects to subcutaneous (SC) 60 mg denosumab every 6 months (Q6M) treatment compared to oral 70 mg alendronate once a week (QW) treatment at the end of treatment period 1 (12…
- Trial name
- NCT00518531
- Testing
- alendronate, denosumab
- Volunteers
- 250 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .
evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)
- Trial name
- NCT04591275
- Testing
- CMAB807 Injection, Prolia®
- Where
- China
- Volunteers
- 278 people
- Sponsor
- Shanghai Biomabs Pharmaceutical Co., Ltd.