Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).
This page lists clinical trials related to Paget’s Disease of Bone from the ClinicalTrials.gov database.
Trial Summary
- Total studies: 24
- Recruiting: 3
- Active, not recruiting: 1
- Completed: 17
- Other: 3
Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.
Recruiting Trials
NCT01353430 — Characterization of Inclusion Body Myopathy Associated With Paget’s Disease of Bone and Frontotemporal Dementia (IBMPFD)
| Status | Recruiting |
| Phase | N/A |
| Sponsor | University of California, Irvine |
| Enrollment | 50 |
| Study Type | OBSERVATIONAL |
| Conditions | Inclusion Body Myopathy With Early-onset Paget Disease and Frontotemporal Dementia; Paget Disease of Bone; Frontotemporal Dementia; Myopathy |
The investigators are researching families with inherited inclusion body myopathy (IBM) and/or Paget disease of bone (PDB) and/or dementia (FTD) which is also called IBMPFD. IBMPFD is caused by mutations in the VCP gene. Our main goal is to understand how changes in the VCP gene cause the muscle, bone and cognitive problems associated with the disease.
The investigators are collecting biologic…
NCT01166854 — Characterization of Familial Myopathy and Paget Disease of Bone
| Status | Recruiting |
| Phase | N/A |
| Sponsor | University of California, Irvine |
| Enrollment | 25 |
| Study Type | OBSERVATIONAL |
| Conditions | Muscle Disorder; Bone Disorder |
| Interventions |
The researcher wants to explore the genetic causes of muscle disease. The researcher is particularly interested in muscle disorders that occur in combination with diseases of bone that appear to be passed on from generation to generation.
Diffuse Optical Spectroscopy will measure the concentrations of blood, water, and lipids (fats, for example) in your tissues. This device essentially measure…
NCT01793168 — Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Sanford Health |
| Enrollment | 20000 |
| Study Type | OBSERVATIONAL |
| Conditions | Rare Disorders; Undiagnosed Disorders; Disorders of Unknown Prevalence; Cornelia De Lange Syndrome; Prenatal Benign Hypophosphatasia |
CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups,…
Active, Not Recruiting
NCT05309954 — Genetic Analysis to Predict the Development of Paget’s Disease
| Status | Active, not recruiting |
| Phase | N/A |
| Sponsor | University of Edinburgh |
| Enrollment | 135 |
| Study Type | OBSERVATIONAL |
| Conditions | Paget Disease; Paget Disease of Bone |
Paget’s disease of the bone (PDB) is a skeletal disorder with a strong genetic component which can be associated with various complications such as pain, bone deformity, arthritis and deafness. Recent advances in understanding the genetic determinants of PDB offer the prospect of developing a genetic profiling test which can be offered to people with a parent or sibling with PDB to determine ho…
Completed Trials
NCT00540566 — Optical Biopsy of Human Skin in Conjunction With Laser Treatment
| Status | Completed |
| Phase | N/A |
| Sponsor | University of California, Irvine |
| Enrollment | 113 |
| Study Type | OBSERVATIONAL |
| Conditions | Malignant Melanoma; Merkel Cell Carcinoma; Basal Cell Carcinoma; Squamous Cell Carcinoma; Atypical Nevi |
| Interventions |
This study is to compare the ability of optical biopsy. Research can use light enters the skin, collected, analyzed by the computer, and a picture created for the pathologist to conventional histologic examination compare with the pathologist looking at the piece of tissue through a microscope makes the diagnosis.
NCT00159419 — Bisphosphonate Therapy for Osteogenesis Imperfecta
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | Indiana University |
| Enrollment | 18 |
| Study Type | INTERVENTIONAL |
| Conditions | Osteogenesis Imperfecta; Osteoporosis; Paget Disease of Bone |
| Interventions | ; |
The study is designed to evaluate the efficacy and safety of “Bisphosphonate Therapy for Osteogenesis Imperfecta (OI).” We, the researchers at Indiana University School of Medicine, are characterizing the changes effected by oral bisphosphonate therapy and comparing them to a regimen of intravenous bisphosphonate therapy in a group of children with OI and also in children with other disorders t…
NCT00051636 — Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget’s Disease of Bone, Including an Extended Observation Period
| Status | Completed |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 172 |
| Study Type | INTERVENTIONAL |
| Conditions | Paget’s Disease of Bone |
| Interventions | ; ; |
The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget’s disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment.
NCT00480662 — A Research Study to Test the Effectiveness of MK0217 in Patients With Paget’s Bone Disease (0217-206)(COMPLETED)
| Status | Completed |
| Phase | Phase 3 |
| Sponsor | Organon and Co |
| Enrollment | 60 |
| Study Type | INTERVENTIONAL |
| Conditions | Paget’s Disease of Bone |
| Interventions |
To test the safety, effectiveness of MK0217 when taken once a week for six months in treating patients with Paget’s bone disease.
NCT00306046 — 18F-Fluoride Positron Emission Tomography (PET) in Paget’s Disease of Bone
| Status | Completed |
| Phase | N/A |
| Sponsor | Université Catholique de Louvain |
| Enrollment | 20 |
| Study Type | INTERVENTIONAL |
| Conditions | Paget’s Disease of Bone |
| Interventions |
18 F-fluoride Positron emission tomography (PET) is able to demonstrate and quantify the metabolic activity locally in the skeleton (1). This technique should, therefore, also be able to demonstrate a dramatic decrease in the metabolic activity in localized monostotic Paget’s disease lesions after therapy. In this condition, indeed, the usual biological markers may be unhelpful to assess the ef…
NCT00103740 — Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget’s Disease of Bone, Including an Extended Observation Period
| Status | Completed |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 185 |
| Study Type | INTERVENTIONAL |
| Conditions | Paget’s Disease of Bone |
| Interventions | ; ; |
The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.
NCT00444535 — Lapatinib and Bevacizumab for Metastatic Breast Cancer
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 52 |
| Study Type | INTERVENTIONAL |
| Conditions | Neoplasms, Breast |
| Interventions | ; |
This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.
NCT00747994 — Genetic Study of Families Affected by Paget’s Disease of Bone
| Status | Completed |
| Phase | N/A |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Enrollment | 83 |
| Study Type | OBSERVATIONAL |
| Conditions | Paget’s Disease of Bone |
Paget’s disease of bone is a frequent bone disorder which usually starts after the age of 40 and which is characterized by bone pain and deformities. Although often without any symptoms, this disease may have severe complications such as fissures, fractures, neurological compression, or deafness. In some cases, it is a genetic disorder transmitted with a dominant autosomal pattern of inheritanc…
NCT00553358 — Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study
| Status | Completed |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 455 |
| Study Type | INTERVENTIONAL |
| Conditions | Neoplasms, Breast |
| Interventions | ; ; |
This is a randomised, open label multicenter Phase III study comparing the efficacy of neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant lapatinib and trastuzumab plus paclitaxel given as neoadjuvant treatment in HER2/ErbB2 over-expressing and/or amplified primary breast cancer.
Patients will be randomised to receive either: lapatinib 1500 mg daily, …
NCT00668200 — Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget’s Disease Treated With Reclast®
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 81 |
| Study Type | INTERVENTIONAL |
| Conditions | Paget’s Disease of the Bone; Hypocalcemia |
| Interventions | ; ; |
This study will evaluate the impact of investigator and patient education and educational materials to foster calcium and vitamin D supplementation to mitigate the potential for hypocalcemia post Reclast® administration in patients with Paget’s disease of bone.
NCT02106455 — Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget’s Disease (All-case Surveillance) -48-week Surveillance -
| Status | Completed |
| Phase | N/A |
| Sponsor | Takeda |
| Enrollment | 315 |
| Study Type | OBSERVATIONAL |
| Conditions | Osseous Paget’s Disease |
| Interventions |
The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets administered once daily (one tablet per dose) in patients with osseous Paget’s disease for 48 weeks from baseline in daily medical practice.
NCT00740129 — Re-treatment of Participants With Paget’s Disease Using Zoledronic Acid
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 6 |
| Study Type | INTERVENTIONAL |
| Conditions | Paget’s Disease of the Bone |
| Interventions |
The purpose of this study was to demonstrate that participants with Paget’s disease of the bone who had responded to zoledronic acid treatment as participants in the core registration studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully treated with a 5 milligram (mg) infusion of zoledronic acid.
NCT00774020 — Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget’s Disease of Bone (PDB)
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 9 |
| Study Type | INTERVENTIONAL |
| Conditions | Paget’s Disease of Bone |
| Interventions |
The purpose of this study is to document the efficacy and safety profiles of single intravenous dose of 5 mg zoledronic acid for the Chinese patients of Paget’s Disease of Bone (PDB).
NCT01526486 — Videoscopic Versus Open Inguinal Lymphadenectomy for Cancer
| Status | Completed |
| Phase | N/A |
| Sponsor | Emory University |
| Enrollment | 29 |
| Study Type | INTERVENTIONAL |
| Conditions | Melanoma; Merkel Cell Carcinoma; Squamous Cell Carcinoma; Penile Carcinoma; Urethral Carcinoma |
| Interventions | ; |
Patients with melanoma, some other rare skin cancers, and some cancers of the penis and scrotum can have their cancer spread to the lymph nodes in the upper part of the leg, called the groin. Medically, this area is called the inguinal area. At present, for melanomas and skin cancers this type of spread is usually found with a special test called a “sentinel lymph node biopsy”. This procedure c…
NCT02802384 — Pathophysiology of Paget’s Disease of Bone
| Status | Completed |
| Phase | N/A |
| Sponsor | Johns Hopkins University |
| Enrollment | 11 |
| Study Type | OBSERVATIONAL |
| Conditions | Paget’s Disease of Bone |
Paget’s disease of the bone is a skeletal disorder which results in increased and disorganized bone remodeling, leading to dense but fragile and expanding bones. The identified genetic causes of Paget’s disease of bone only explain why bone is destroyed, but not why the bone formed in its place is abnormal.
Current treatment for people with Paget’s disease of the bone is limited to patients wi…
NCT03096847 — Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer
| Status | Completed |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 502 |
| Study Type | INTERVENTIONAL |
| Conditions | Advanced Metastatic Breast Cancer |
| Interventions | ; ; |
This was a national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in patients with HR+, HER2-negative advanced (recurrent or metastatic) breast cancer. Patients were treated with daily doses of 600 mg ribociclib (3-weeks-on/1-week-off schedule) in combination with 2.5 mg letrozole daily (continuous dosing). …
NCT03438123 — Data Collection Study for the Spectrum Dynamics Multi-purpose CZT SPECT Camera
| Status | Completed |
| Phase | N/A |
| Sponsor | Spectrum Dynamics |
| Enrollment | 140 |
| Study Type | INTERVENTIONAL |
| Conditions | Dementia; Parkinson Disease; Pulmonary Hypertension; Heart Diseases; Paget Disease |
| Interventions |
This study evaluates SPECT image data acquired from Spectrum Dynamics’ multi-purpose CZT SPECT-CT camera. All subjects will undergo routine clinical Anger SPECT imaging and an additional SPECT acquisition on the CZT SPECT camera. Additionally some subjects will undergo CT on the CZT SPECT-CT camera. The quality of images from each device will be compared.
Other (Unknown)
NCT00403598 — Preliminary Study for Identification of Calcium-Binding Proteins in the Serum in Various Metabolic Bone Disorders
| Status | Unknown |
| Phase | N/A |
| Sponsor | Sheba Medical Center |
| Enrollment | N/A |
| Study Type | OBSERVATIONAL |
| Conditions | Osteoporosis; Osteitis Deformans; Parathyroid Diseases |
The purpose of this study is to determine whether the serum levels of certain calcium-binding proteins may be helpful in the diagnosis and management of metabolic bone diseases.
Other (Terminated)
NCT00615628 — Inheritance of Osteosarcoma & Paget’s Disease Through Chromosome 18:
| Status | Terminated |
| Phase | N/A |
| Sponsor | State University of New York - Upstate Medical University |
| Enrollment | 8 |
| Study Type | OBSERVATIONAL |
| Conditions | Osteosarcoma; Paget’s Disease |
Researchers have previously demonstrated loss of heterozygosity in a region on chromosome 18q, associated with osteogenic sarcomas in bone affected by Paget’s disease. The loci used in this study are specifically described by those authors as showing loss of heterozygosity in 6 of 7 affected families.
NCT01882231 — Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma and Ewing Sarcoma
| Status | Terminated |
| Phase | N/A |
| Sponsor | Vanderbilt-Ingram Cancer Center |
| Enrollment | 6 |
| Study Type | INTERVENTIONAL |
| Conditions | Osteosarcoma; Paget’s Disease; Ewing Sarcoma |
| Interventions |
The objective of these studies is to use changes in 3 Tesla MRI measurements of tumor protein content, cell density, and microvessel perfusion, obtained before and after a single cycle of NAC, to predict eventual tumor response observed at the conclusion of NAC, within patients with osteosarcoma or Ewing Sarcoma.