Clinical trials: Denosumab
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
Osteoporosis, Knee Osteoarthritis
Knee Osteoarthritis Outcome Measures in Arthritic Patients With Osteoporosis
The purpose of this study is to generate proof of concept human data by evaluating osteoarthritis outcome measures in arthritic patients that are prescribed Forteo® as the standard of care to treat their primary diagnosis of…
- Trial name
- NCT03217513
- Where
- United States
- Sponsor
- Edward Fox
Osteoporosis
The Relationship Between the Residual Renal Function and Osteoporosis Treatment
The relationship between osteoporosis drugs and kidney damage is unclear. In this study, we plan to reveal relationship between osteoporosis drugs and kidney damage.
- Trial name
- NCT02304887
- Testing
- Bis, SERM Teriparatide, Denosumab
- Where
- Japan
- Volunteers
- 1,000 people
- Sponsor
- Toshihiko Kono
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
Bone Diseases, Pain
Denosumab Treatment for Fibrous Dysplasia
Objectives: The primary objective of this study is to evaluate the effect of denosumab on bone turnover in individuals with fibrous dysplasia (FD).
- Trial name
- NCT03571191
- Testing
- Denosumab
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
Osteolysis
Denosumab for Treating Periprosthetic Osteolysis.
The main objective is to study the efficacy of denosumab in reducing wear-induced osteolysis around uncemented acetabular implants used in total hip arthroplasty.
- Trial name
- NCT02299817
- Testing
- Denosumab
- Where
- Sweden
- Volunteers
- 20 people
- Sponsor
- Olof Skoldenberg
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
Denosumab Allergy
Denosumab and Screw Fixation for Osteoporotic Compression Fracture
Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: a parallel double-blind randomized controlled clinical trial
- Trial name
- NCT05065164
- Testing
- Denosumab Only Product
- Where
- China
- Volunteers
- 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
Osteoporosis, Postmenopausal
Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)
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
- Trial name
- EURODEC (NCT05575167)
- Testing
- Zoledronate or Alendronate
- Where
- 9 sites in France, Greece and 1 more
- Volunteers
- 122 people
- Sponsor
- 424 General Military Hospital
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
Breast Neoplasm Female, Stage I Breast Cancer
Biomarker Study of the Antitumoral Activity of Denosumab in the Pre- Operative Setting of Early Breast Cancer
This is a biomarker study designed to test the preclinically generated hypothesis of anti-tumoral activity of denosumab in patients with early breast cancer candidates a tumour excision
- Conditions
- Breast Neoplasm Female, Stage I Breast Cancer, Stage II Breast Cancer, Hormone Receptor Negative Neoplasm
- Trial name
- D-BIOMARK (NCT03691311)
- Testing
- Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Institut Català d'Oncologia
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