Clinical trials: Disorders of Calcium and Bone Metabolism
Hypophosphatasia
Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan
This is a multicenter study in Japan. Eleven sites which have already participated in the investigator-initiated clinical study (Early Access Program) will participate in this study.The objective of this study is to gain further…
- Trial name
- NCT02531867
- Testing
- Asfotase Alfa
- Volunteers
- 13 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
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
Vitamin D Deficiency
Treatment of Vitamin D Insufficiency
The purpose of this study is to answer the following questions: Does vitamin D increase calcium absorption, bone mass and muscle mass and function in women past menopause who have mildly low vitamin D levels? Do these benefits…
- Trial name
- NCT00933244
- Testing
- High Dose Vitamin D3, Low Dose Vitamin D3
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Postmenopausal Osteoporosis
A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)
The purpose of the event-driven base study is to determine the safety and efficacy, especially fracture risk reduction, of odanacatib in postmenopausal women diagnosed with osteoporosis.
- Trial name
- NCT00529373
- Testing
- Odanacatib, Vitamin D3, Calcium carbonate
- Volunteers
- 16,071 people
- Sponsor
- Merck Sharp & Dohme LLC
Paget's Disease of the Bone, Hypocalcemia
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®
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…
- Trial name
- NCT00668200
- Testing
- Reclast (ZOL446, zoledronic acid), Calcium, Vitamin D
- Where
- 9 sites in United States
- Volunteers
- 81 people
- Sponsor
- Novartis Pharmaceuticals
Fibrous Dysplasia Of Bone
Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia
Background: Fibrous dysplasia (FD) is a disorder that affects bone growth. Affected bone tissue is weakened, and people with FD are prone to deformities, fractures, and other problems.
- Trial name
- NCT05509595
- Testing
- Burosumab
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
X-linked Hypophosphatemia
Examining the Effect of Burosumab on Muscle Function
Patients with X-linked hypophosphatemia (XLH) often report symptoms of fatigue and weakness particularly after exertion, in addition to their skeletal complaints.
- Trial name
- NCT04146935
- Testing
- Burosumab Injection [Crysvita]
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Yale University
Osteoporosis
A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)
The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo.
- Trial name
- NCT01120600
- Testing
- Odanacatib, Vitamin D3, Calcium carbonate
- Volunteers
- 294 people
- Sponsor
- Merck Sharp & Dohme LLC
Osteoporosis
A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis
- Trial name
- NCT00525798
- Testing
- SMC021 Oral calcitonin
- Where
- 16 sites in United States, Brazil and 10 more
- Volunteers
- 4,665 people
- Sponsor
- Nordic Bioscience A/S
Bone Loss, Post Menopausal Osteoporosis
Lactobacillus Acidophilus and Postmenopausal Women
This study aims to evaluate the effect of Lactobacillus acidophilus supplementation on calcium status and bone densitometry in postmenopausal women in a randomized, double-blind placebo-controlled study.
- Conditions
- Bone Loss, Post Menopausal Osteoporosis, Mineralization
- Trial name
- LaBon (NCT05332626)
- Testing
- Probiotic group
- Where
- Poland
- Volunteers
- 90 people
- Sponsor
- Poznan University of Life Sciences
Vitamin D Deficiency
Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder
It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3 (Rocaltrol) in the patients with CKD stage 3-5.
- Trial name
- NCT01633853
- Testing
- Vitamin D2, 1,25(OH)2 Vit D3
- Where
- China
- Volunteers
- 204 people
- Sponsor
- Dongliang Zhang, MD
X-linked Hypophosphatemia
Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)
The primary efficacy objective of this study is to establish the effect of burosumab treatment compared with placebo on increasing serum phosphorus levels in adults with XLH.
- Trial name
- NCT02526160
- Testing
- burosumab
- Where
- 25 sites in United States, France and 5 more
- Volunteers
- 134 people
- Sponsor
- Kyowa Kirin, Inc.
Hypophosphatasia (HPP)
Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)
This clinical trial studies the long term safety and efficacy of asfotase alfa in children with HPP who completed Study ENB-006-09 (NCT00952484).
- Trial name
- NCT01203826
- Testing
- Asfotase Alfa
- Where
- 2 sites in United States, Canada
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hypophosphatasia (HPP)
Retrospective, Non-interventional Natural History of Patients With Juvenile-onset Hypophosphatasia (HPP)
The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP.
- Trial name
- NCT02104219
- Where
- 19 sites in United States, Australia and 6 more
- Volunteers
- 32 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Chronic Kidney Disease, Vitamin D Deficiency
Vitamin D and Coronary Calcification Study
Patients with chronic kidney disease (CKD) have a higher mortality rate than the general population, with cardiovascular disease (CVD) accounting for approximately 50% of deaths.
- Conditions
- Chronic Kidney Disease, Vitamin D Deficiency, Coronary Calcification, Disorders of Calcium and Bone Metabolism
- Trial name
- VCOR (NCT00752102)
- Testing
- Calcitriol (Rocaltrol®), Paricalcitol
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Joslin Diabetes Center
Bone Resorption, Osteoporosis
The Effect of Protein Supplementation on Bone Health in Healthy Older Men and Women
Women and men consuming a low protein diet may be at risk for bone loss. The purpose of this study is to determine whether a daily protein supplement will improve bone health among healthy older adults.
- Trial name
- NCT00421408
- Testing
- Whey protein supplement
- Where
- 2 sites in United States
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Yale University
Osteoporosis, Osteopenia
Does Treatment of Hypovitaminosis D Increase Calcium Absorption?
The purpose is to perform a one-year study designed to assess whether treatment of hypovitaminosis D increases intestinal absorption of calcium, subsequent retention of calcium within bone, decreases bone turnover, and favorably…
- Conditions
- Osteoporosis, Osteopenia, Vitamin D Deficiency, Hypoparathyroidism
- Trial name
- NCT00581828
- Testing
- Vitamin D
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Hyperparathyroidism, Secondary
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.
- Trial name
- NCT01785849
- Testing
- Etelcalcetide
- Where
- 118 sites in United States, Australia and 13 more
- Volunteers
- 508 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism, Chronic Kidney Disease
Study to Assess Patient Management Practices and Quality of Life With Paricalcitol Capsules in the Treatment of Secondary Hyperparathyroidism in Stage 3-5 Chronic Kidney Disease Patients Not Yet on Dialysis
Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 \& 4 Chronic Kidney Disease (CKD).
- Trial name
- CAPITOL (NCT01265992)
- Where
- 10 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- AbbVie (prior sponsor, Abbott)