Clinical trials: Osteomalacia
Endocrine System Diseases, Vitamin D Deficiency
Serum Sclerostin Level & Treatment of Vitamin D Deficiency
The aim of this study is to determine serum sclerostin levels and change in serum sclerostin levels in patients with Vitamin D deficiency treated with calcium and vitamin D.
- Trial name
- OMSOST (NCT01553344)
- Where
- Turkey (Türkiye)
- Volunteers
- 26 people
- Sponsor
- Bagcilar Training and Research Hospital
Vitamin D Deficiency, Secondary Hyperparathyroidism
Vitamin D Status in Males in Jerusalem Area and Its Correlation to Parathyroid Hormone (PTH) Level and Bone Mineral Density
Because of its high sun exposure, Israel was traditionally supposed to be protected from vitamin D deficiency, and the country food products hardly contain vitamin D supplements.
- Conditions
- Vitamin D Deficiency, Secondary Hyperparathyroidism, Osteomalacia
- Trial name
- NCT01025128
- Testing
- 25 OH vitamin D
- Where
- Israel
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Clalit Health Services
Osteoarthritis, Osteoporosis
Development of a Non-invasive Assessment of Human Bone Quality Using Spatially Offset Raman Spectroscopy
In this study spatially offset Raman spectroscopy (SORS), which allows the collection of Raman spectra through turbid media, is being applied to collect Raman spectra of bone.
- Conditions
- Osteoarthritis, Osteoporosis, Osteogenesis Imperfecta, Rickets / Osteomalacia
- Trial name
- NCT02814591
- Testing
- spatially offset Raman spectrometer (SORS)
- Volunteers
- 245 people, healthy volunteers welcome
- Sponsor
- University College, London
X-linked Hypophosphatemia, Tumor-Induced Osteomalacia
Expanded Access to Burosumab
Individual patient expanded access requests may be considered for patients who have no other treatment options
- Trial name
- NCT03775187
- Testing
- Burosumab
- Sponsor
- Kyowa Kirin Co., Ltd.
Bone Diseases, Osteomalacia
Study of the Diagnostic Value of Stable Calcium Isotope Profiling in Bone and Calcium Disorders
The purpose of this study is to determine whether mass spectrometry analysis of stable (non-radioactive) calcium isotopes in plasma or urine samples can help in the diagnosis of bone and calcium disorders.
- Conditions
- Bone Diseases, Osteomalacia, Osteoporosis
- Trial name
- eCaSIS (NCT02252679)
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
XLH
A Study of KRN23 in Adult and Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia
Before switching to the post-marketing study: Assess the efficacy and safety of KRN23 administered subcutaneously once every 4 or 2 weeks in adult or children with XLH After switching to the post-marketing study: To evaluate the…
- Trial name
- NCT04308096
- Testing
- KRN23
- Where
- 10 sites in Japan, South Korea
- Volunteers
- 27 people
- Sponsor
- Kyowa Kirin Co., Ltd.
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.
Tooth Loss, Vitamin D3 Deficiency
Dental Implants Rehabilitation in Patients With Vitamin D3 Imbalance
Interventional retrospective prospective randomized clinical trial (RCT) in parallel groups. The sample size is 384 patients with loss of teeth and vitamin D imbalance.
- Conditions
- Tooth Loss, Vitamin D3 Deficiency, Osteomalacia
- Trial name
- NCT04841213
- Testing
- Dental implantation
- Where
- 2 sites in Russia
- Volunteers
- 384 people
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Osteomalacia
Cinacalcet for Fibroblast Growth Factor 23 (FGF23)-Mediated Hypophosphatemia (Hypophosphatemic Rickets)
Background: Hypophosphatemia is a condition where a person has low levels of phosphorus in the blood. Low blood phosphorus can cause muscle and bone weakness (such as rickets) and teeth problems.
- Trial name
- NCT01748812
- Testing
- Osteomalacia
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
Vitamin D Deficiency, Low Bone Density
Nursing-Home Residents Given Bread Fortified With Vitamin D3
Background. For older adults, serum 25-hydroxyvitamin D (25(OH)D) higher than 75 nmol/L lowers fracture risk and attainment of this 25(OH)D target may require 125 mcg (5000 IU)/d of vitamin D3.
- Trial name
- NCT00789503
- Testing
- Bread fortified with vitamin D3 and calcium
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Toronto
Hypophosphatasia (HPP)
Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)
This clinical trial studied the safety and efficacy of asfotase alfa in children with HPP compared to a historical control group.
- Trial name
- NCT00952484
- Testing
- asfotase alfa
- Where
- 2 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
X-Linked Hypophosphatemia
Study of Longitudinal Observation for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia in Collaboration With Asian Partners
Through observation of patients with X-linked hypophosphatemic rickets/osteomalacia (XLH) for up to 10 years, the study intends to collect data that allow achievement of the following objectives: 1.
- Trial name
- SUNFLOWER (NCT03745521)
- Testing
- no intervention
- Where
- Japan
- Volunteers
- 226 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Hypophosphatasia, Bone Disease
Non-interventional Substudy of ALX-HPP-502 to Assess Natural History of Patients With Juvenile-onset HPP Who Served as Historical Controls in ENB-006-09
The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP who served as historical controls in ENB-006-09.
- Trial name
- NCT02235493
- Testing
- Retrospective Case Only
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome
A Study of KRN23 in Subjects With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome
Before switching to the post-marketing study: To evaluate the efficacy and safety of KRN23 after its 144-week once every 4 weeks (Q4W) repeated SC administration to Japanese and Korean patients with TIO or ENS by a multicenter…
- Trial name
- NCT02722798
- Testing
- KRN23
- Where
- 3 sites in Japan, South Korea
- Volunteers
- 14 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Hypophosphatasia
Expanded Access Program for Asfotase Alfa Treatment for Patients With Infantile- or Juvenile-onset Hypophosphatasia (HPP)
This clinical trial is being conducted in Hypophosphatasia, a bone disorder caused by gene mutation(s) resulting in bone defects. These gene mutations cause low levels of an enzyme needed to harden bone.
- Trial name
- NCT02496689
- Testing
- asfotase alfa
- Where
- 5 sites in United States, France
- Sponsor
- Alexion Pharmaceuticals, Inc.
Tumor Induced Osteomalacia (TIO), Epidermal Nevus Syndrome (ENS)
Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)
The primary objectives of this study are to evaluate the effect of burosumab treatment on: Increasing serum phosphorus levels in adults with TIO or ENS-associated osteomalacia Improvement in TIO/ENS-associated osteomalacia as…
- Trial name
- NCT02304367
- Testing
- Burosumab
- Where
- 7 sites in United States
- Volunteers
- 17 people
- Sponsor
- Kyowa Kirin, Inc.
Tumor-induced Osteomalacia (TIO)
Tumor-induced Osteomalacia Disease Monitoring Program
The objectives of this observational study are to assess the long-term safety and long-term effectiveness of burosumab in patients with TIO who are being treated with burosumab as prescribed by their physician and to monitor the…
- Trial name
- NCT04783428
- Testing
- No intervention
- Where
- 6 sites in United States, Argentina
- Volunteers
- 23 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of CRYSVITA injection 10, 20, and 30mg, equivalent to in routine clinical settings
- Trial name
- NCT06202027
- Testing
- FGF23-related hypophosphataemic rickets and osteomalacia
- Where
- 13 sites in South Korea
- Volunteers
- 100 people
- Sponsor
- Kyowa Kirin Korea Co., Ltd.
X-linked Hypophosphatemia
Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)
The primary objective of this study is to establish the effect of KRN23 treatment on improvement in XLH-associated osteomalacia as determined by osteoid volume (osteoid volume/bone volume, OV/BV).
- Trial name
- NCT02537431
- Testing
- burosumab
- Where
- 14 sites in United States, Canada and 4 more
- Volunteers
- 14 people
- Sponsor
- Kyowa Kirin, Inc.
PET / CT, PET / MR
Study of the Diagnostic Value of Hybrid PET/MR and PET/CT in Neuroendocrine Diseases and Tumor Induced Osteomalacia
Neuroendocrine tumors (NETs) are rare neoplasms arising from the diffuse endocrine system and spreading throughout the different organs and tissues of the body.
- Conditions
- PET / CT, PET / MR, Neuroendocrine Tumors, Osteomalacia
- Trial name
- NCT04045834
- Testing
- 68Ga-DOTA-TATE PET/MR and PET/CT imaging
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology