Clinical trials: Disorders of Calcium and Bone Metabolism
Osteoporosis
Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.
This study will evaluate the safety, tolerability and exposure of SB-751689 when administered alone at supratherapeutic doses and when SB-751689 is co administered with ketoconazole, a PGP/CYP3A4 inhibitor that increases exposure…
- Trial name
- NCT00468689
- Testing
- SB-751689 oral tablets (100 and 400 ng), Ketoconazole (NIZORAL) oral tablets (200 mg)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
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.
Osteoporosis
Calcium Supplementation in Postmenopausal Women
This study is evaluating the effects of calcium supplementation on the efficacy and safety of recombinant parathyroid hormone (ALX1-11) in postmenopausal women with osteoporosis.
- Trial name
- CAP (NCT00172172)
- Testing
- PTH/Calcium
- Where
- 27 sites in United States, Argentina and 1 more
- Volunteers
- 374 people
- Sponsor
- Shire
Secondary Hyperparathyroidism
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney…
- Trial name
- NCT01414114
- Testing
- Etelcalcetide
- Volunteers
- 37 people
- Sponsor
- KAI Pharmaceuticals
Osteoporosis
Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial.
- Trial name
- NCT00145327
- Testing
- Zoledronic Acid
- Where
- 31 sites in United States, Germany
- Volunteers
- 2,456 people
- Sponsor
- Novartis
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.
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.
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
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.
Osteoporosis
CONFIRM EXTENSION - Long-term Follow-up Study of Patients Treated with AGN1 LOEP
The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study.
- Trial name
- NCT04511364
- Testing
- Clinical imaging is performed during the 24 and 60 month follow-up visits
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- AgNovos Healthcare, LLC
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
X-linked Hypophosphatemia (XLH)
Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age
A Phase 1/2, Open-label, Multicenter, Non-randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Paediatric Patients from Birth to Less than 1 Year of Age with X-linked Hypophosphatemia…
- Trial name
- NCT04188964
- Testing
- Burosumab
- Where
- 9 sites in Austria, France and 4 more
- Volunteers
- 16 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
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
Breast Cancer, Prostate Cancer
Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/Prostate Cancer Patients Treated With Denosumab/Zoledronic Acid
This is an open-label exploratory study of CTAP101 Capsules in patients with bone metastases arising from either breast or prostate cancer, who are taking anti-resorptive therapy.
- Conditions
- Breast Cancer, Prostate Cancer, Bone Neoplasms, Hypocalcemia
- Trial name
- NCT02274623
- Testing
- CTAP101 Capsules
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- OPKO Health, Inc.
Osteoporosis
A Study to Evaluate the Effects of SB-751689 or rhPTH(1-34) on Excretion of Calcium and Phosphate in Women
SB-751689 may alter calcium and phosphate handling at the kidney level. This study will examine what happens to calcium and phosphate, and other electrolytes, at the kidney after treatment with SB-751689 for 1 month.
- Trial name
- NCT00532077
- Testing
- rhPTH(1-34), SB-751689 100 mg, SB-751689 400 mg
- Where
- 5 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Osteopenia
Study to Investigate if Adding Lactulose to Vitamin D and Calcium Has an Effect on the Preservation of Bone in Postmenopausal Women
This is a randomized, double-blind, multicentre, parallel pilot clinical trial to study the efficacy of a treatment of lactulose 15 ml + vitamin D 400 U + calcium 0.5 g compared to lactulose placebo 15 ml + vitamin D 400 U +…
- Trial name
- NCT00160264
- Testing
- Lactulose, Vitamin D, Calcium
- Where
- 3 sites in Spain
- Volunteers
- 40 people
- Sponsor
- Solvay Pharmaceuticals
Post Menopausal Osteoporosis
Evaluation of Adherence With Bisphosphonates and Calcium and Vitamin D Supplements in Women With Postmenopausal Osteoporosis
This study aims to evaluate the adherence of patients to combined treatment with bisphosphonates and calcium and vitamin D supplements, which is one of the usual treatments for postmenopausal osteoporosis.
- Trial name
- OSTEOAD (NCT07105163)
- Where
- 20 sites in Spain
- Volunteers
- 230 people
- Sponsor
- Procare Health Iberia S.L.