Clinical trials: Disorders of Calcium and Bone Metabolism
Vitamin D Deficiency, Iodine Deficiency
Vitamin D, Iodine, and Lead Levels in Haitian Infants and Children.
Vitamin D deficiency is common worldwide, including in infants and children, and rickets remains a public health concern in many developing countries.
- Conditions
- Vitamin D Deficiency, Iodine Deficiency, Hypothyroidism, Rickets
- Trial name
- Haiti (NCT02301520)
- Where
- 2 sites in Haiti
- Volunteers
- 299 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Secondary Hyperparathyroidism, Chronic Kidney Disease Mineral and Bone Disorder
Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients
This is a prospective cohort study aimed to evaluate change of cardiovascular calcification after parathyroidectomy in patients with end-stage renal disease on dialysis compared with control group on conservative treatment.
- Conditions
- Secondary Hyperparathyroidism, Chronic Kidney Disease Mineral and Bone Disorder, Vascular Calcification, Dialysis
- Trial name
- NCT03937349
- Where
- Russia
- Volunteers
- 63 people
- Sponsor
- Saint Petersburg State University, Russia
Hypophosphatasia
Safety and Efficacy Study of ENB-0040 in Juvenile Patients With Hypophosphatasia (HPP)
This Clinical Trial is being conducted to study Hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone.
- Trial name
- NCT00894075
- Testing
- ENB-0040
- Sponsor
- Alexion Pharmaceuticals, Inc.
X-linked Hypophosphatemia
Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH
This is phase 3b open-label, international, multicenter study to continue to monitor the long-term safety and efficacy of burosumab in adult patients with XLH that participated in previous clinical trials with burosumab…
- Trial name
- NCT03920072
- Testing
- Burosumab
- Where
- 10 sites in France, Ireland and 2 more
- Volunteers
- 35 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Rickets
Study to Assess the Use of a Simple Lab Test to Screen for Rickets in Children
Some experts recommend that all breastfed babies receive supplemental vitamin D. The purpose of this study is to determine the rate of vitamin D use in breastfed babies, the recommendations of pediatricians regarding vitamin D…
- Trial name
- NCT00502866
- Where
- United States
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- Agency for Healthcare Research and Quality (AHRQ)
Galactose Single Point (GSP), Residual Liver Function
Clinical Study for Development of Oral Galactose Single Point (OGSP) Solution (G.S.P. Oral Solution®)
The primary objective is to determine the oral galactose single point (OGSP) cutoff values to discriminate subjects with different hepatic function.
- Trial name
- NCT03457311
- Testing
- G.S.P. Oral Solution 400 mg/ml
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Richever Enterprise Co., Ltd.
Vascular Calcification, Vertebral Fracture
Observer Variability in Scoring Abdominal Aortic Calcifications and Vertebral Morphometry
BACKGROUND In the context of a progressively aging population, monitoring the status of Vascular Calcifications (VC) and Vertebral Fractures (VF) over time would be of primary importance, as VC and VF are recognized to be…
- Trial name
- CALCIFY2D (NCT03839732)
- Testing
- Score of abdominal aorta calcifications
- Where
- Italy
- Volunteers
- 44 people
- Sponsor
- Istituto Ortopedico Rizzoli
X-linked Hypophosphatemic Rickets/Osteomalacia
A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia
The objective of this study is to assess the safety and tolerability of KRN23 after a single subcutaneous (SC) administration in subjects with X-linked hypophosphatemic rickets/osteomalacia (XLH) in Japan or Korea.
- Trial name
- NCT02181764
- Testing
- KRN23
- Where
- 2 sites in Japan, South Korea
- Volunteers
- 15 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Acute Lymphoblastic Leukemia, Vitamin d Deficiency
Effect of Supplementation With ω-3 Fatty Acids, Vitamin D and Calcium in Patients With Acute Lymphoblastic Leukemia.
The purpose of this study is to evaluate the efficacy of supplementation with Omega 3, Vitamin D and Calcium, in a cohort of children with ALL undergoing treatment and compare changes in the concentrations of biomarkers of bone…
- Trial name
- NCT05950204
- Testing
- ω-3 polyunsaturated fatty acids (DHA and EPA), Vitamin D (cholecalciferol), Calcium (calcium carbonate)
- Where
- Mexico
- Volunteers
- 40 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Hyperparathyroidism, Secondary
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.
- Trial name
- NCT01785875
- Testing
- Etelcalcetide
- Where
- 208 sites in United States, Australia and 15 more
- Volunteers
- 891 people
- Sponsor
- Amgen
Hemodialysis
Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study
The goal of this Prospective Observational Study of comparative effectiveness is to provide real world evidence of the effect of Etelcalcetide in increasing actives form VKDPs levels such as BGP and MGP at 3, 9 and 18 months from…
- Trial name
- ETERNITY-ITA (NCT06352957)
- Volunteers
- 160 people
- Sponsor
- Istituto di Fisiologia Clinica CNR
Osteoporosis
Dose Effects of SCF on Calcium Metabolism and GI Microflora in Adolescents
Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties in rats and in adolescent boys and girls.
- Trial name
- NCT01660503
- Testing
- 0 grams SCF, 10 grams SCF, 20 grams SCF
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Purdue University
Chronic Kidney Diseases
SOP's for CKD-MBD-Biomarkers
CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder) is an extensive disease and includes dysfunction of the mineral metabolism, the bone metabolism and cardiovascular diseases in the context of renal insufficiency.
- Trial name
- NCT02708368
- Testing
- blood withdrawal
- Where
- 2 sites in Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- RWTH Aachen University
Breast Neoplasms, Breast Cancer
An Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) in Patients With Breast Cancer
This study is intended to evaluate the safety, tolerability, and possible effectiveness of an investigational humanized monoclonal antibody (CAL) to the parathyroid hormone-related protein (PTHrP) when compared to zoledronic acid…
- Conditions
- Breast Neoplasms, Breast Cancer, Metastasis
- Trial name
- NCT00051779
- Testing
- CAL
- Where
- 38 sites in United States
- Sponsor
- Chugai Pharma USA
Hyperparathyroidism, Primary, Osteoporosis
Efficacy of Cinacalcet in the Control of Primary Hyperparathyroidism
To assess the efficacy and safety of treatment with cinacalcet and with cinacalcet plus alendronate in controlling bone loss induced by primary hyperparathyroidism.
- Trial name
- CA-PHP (NCT02417389)
- Testing
- cinacalcet, Alendronate
- Where
- Italy
- Volunteers
- 22 people
- Sponsor
- Istituto Auxologico Italiano
Osteoporosis
Long-term Nutritional Intervention Study to Determine How Protein Affects Calcium Metabolism
Osteoporosis is a major health problem in men and women in this country and the incidence of this disease is rising. We think that environmental factors such as nutrition may play a role in the increasing prevalence of…
- Trial name
- NCT00671944
- Testing
- Low protein diet
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Yale University
Hyperparathyroidism, Secondary
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.
- Trial name
- NCT01788046
- Testing
- Etelcalcetide
- Where
- 106 sites in United States, Australia and 13 more
- Volunteers
- 515 people
- Sponsor
- Amgen
Low Bone Density
Age Related Changes in Calciotropic Hormones and Their Impact on Male Osteoporosis
The purpose of this pilot study is to generate preliminary data regarding the skeletal effects of age-related changes in calcium and vitamin D metabolism in older men.
- Trial name
- NCT00588874
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Yale University
Spinal Muscular Atrophy, Fragile X Syndrome
Early Check: Expanded Screening in Newborns
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and…
- Conditions
- Spinal Muscular Atrophy, Fragile X Syndrome, Fragile X - Premutation, Duchenne Muscular Dystrophy
- Trial name
- NCT03655223
- Testing
- Confirmatory Testing
- Where
- United States
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- RTI International
End Stage Renal Disease, Kidney Transplantation
Bone Mass and Strength After Kidney Transplantation
The purpose of this study is to test whether active vitamin D (calcitriol) protects bones from weakening and protects blood vessels from calcium deposits over the first year of kidney transplantation.
- Conditions
- End Stage Renal Disease, Kidney Transplantation, Bone Loss, Fractures
- Trial name
- NCT02224144
- Testing
- Vitamin D3, Calcitriol
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Columbia University