Clinical trials: Bone Metabolism Disorders
Postmenopausal Osteoporosis
A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis
The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry…
- Trial name
- NCT02791516
- Testing
- Romosozumab
- Where
- 10 sites in South Korea
- Volunteers
- 67 people
- Sponsor
- Amgen
Epilepsy, Bone Loss
Antiepileptic Drugs and Osteoporotic Prevention Trial
Study Design: (e.g., Controlled, Double-Blind, Randomized, Parallel): Randomized, double-blind, placebo controlled of a bisphosphonate in the prevention of bone loss associated with the use of antiepileptic drugs.
- Conditions
- Epilepsy, Bone Loss, Osteoporosis, Fractures
- Trial name
- ADOPT (NCT00869622)
- Testing
- Risedronate
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Boston VA Research Institute, Inc.
Pain, Neuropathic, Epilepsy
Cancer in Patients With Gabapentin (GPRD)
High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by spontaneous reports in AERS or in the…
- Conditions
- Pain, Neuropathic, Epilepsy, Renal Pelvis Cancer, Pancreatic Cancer
- Trial name
- NCT01236053
- Testing
- Gabapentin prescriptions
- Volunteers
- 2,323,608 people
- Sponsor
- GlaxoSmithKline
Hyperparathyroidism, Secondary
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).
- Trial name
- NCT01932970
- Testing
- Etelcalcetide
- Where
- 40 sites in United States
- Volunteers
- 158 people
- Sponsor
- Amgen
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
Osteopenia
Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method
The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture.
- Trial name
- NCT00386360
- Testing
- risedronate
- Where
- 9 sites in Argentina, Australia and 5 more
- Volunteers
- 161 people
- Sponsor
- Warner Chilcott
Hypercalciuria, Hypercalciuria, Familial Idiopathic
The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass
The purpose of this study is to assess if estrogen replacement normalizes urinary calcium excretion in postmenopausal women with hypercalciuria and low bone mass and to assess for differences in response to estrogen replacement…
- Conditions
- Hypercalciuria, Hypercalciuria, Familial Idiopathic, Osteopenia, Osteoporosis
- Trial name
- NCT01928082
- Testing
- Transdermal estradiol
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Chicago
Osteoporosis, Atypical Femoral Fracture
Fracture (FX) Improvement With Teriparatide: FiX-IT Study
This open label comparison study examines the hypothesis that teriparatide given immediately following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will enhance healing and improve bone mineral…
- Trial name
- FiX-IT (NCT01705587)
- Testing
- teriparatide
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Susan L. Greenspan
Vertebral Compression Fracture
Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression fractures has been shown to be successful in providing acute pain relief, enabling improved function, and restoring of vertebral body…
- Trial name
- NCT01383616
- Testing
- Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Hospital for Special Surgery, New York
Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With, Glucocorticoid-induced Osteoporosis
Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis
To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 year of age with Glucocorticoid (GC)-induced…
- Trial name
- NCT03164928
- Testing
- Denosumab
- Where
- 38 sites in United States, Australia and 11 more
- Volunteers
- 24 people
- Sponsor
- Amgen
Osteoporosis
Bone Microarchitecture in Osteopenic Postmenopausal Women
The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.
- Trial name
- NCT00577395
- Testing
- risedronate
- Where
- 4 sites in United States, Argentina
- Volunteers
- 13 people
- Sponsor
- Warner Chilcott
Postmenopausal Osteoporosis, Osteoporosis
Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women
Parathyroid hormone (PTH) increases bone formation and thereby improves bone density and bone strength in postmenopausal women with osteoporosis. However, prolonged PTH treatment increases bone formation less and less over time.
- Trial name
- NCT00086619
- Testing
- synthetic hPTH 1-34
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Massachusetts General Hospital
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
Hypoparathyroidism
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol.
- Trial name
- NCT00001304
- Testing
- Synthetic Human Parathyroid Hormone 1-34, Calcitriol & Calcium
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Osteoporosis
Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.
- Trial name
- NCT00542425
- Testing
- teriparatide, BA058 20 µg, BA058 40 µg
- Where
- United States
- Volunteers
- 222 people
- Sponsor
- Radius Health, Inc.
Type 2 Diabetes Mellitus
Changes in Bone Turnover With Increased Incretin Hormone Exposure
The purpose of this study is to determine if the use of sitagliptin increases bone formation and reduces bone turnover in postmenopausal women with type 2 diabetes.
- Trial name
- DRTC (NCT01374568)
- Testing
- sitagliptin
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Osteoporosis, Breast Cancer
Effects of Exemestane on Bone Strength
The NCIC CTG was conducting an international breast cancer prevention trial (MAP.3) examining the effects of a new therapy (exemestane) for breast cancer prevention in postmenopausal women at increased risk of developing this…
- Trial name
- MAP3BSS (NCT01144468)
- Where
- 4 sites in United States, Canada
- Volunteers
- 351 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Postmenopausal Osteoporosis
A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®
The Study will be conducted to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women with Osteoporosis.
- Trial name
- NCT05405725
- Testing
- ENZ215, Prolia
- Where
- 48 sites in Bulgaria, Czechia and 5 more
- Volunteers
- 504 people
- Sponsor
- Enzene Biosciences Ltd.
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.
Diabetes Mellitus, Asthma
Evaluation of VLER-Indiana Health Information Exchange Demonstration Project
Three out of four Veterans receive a portion of their care from non-VA providers. On April 9, 2009, President Barack Obama directed the Department of Veterans Affairs and the Department of Defense to create the Virtual Lifetime…
- Conditions
- Diabetes Mellitus, Asthma, Cardiovascular Diseases, Heart Failure
- Trial name
- VLER-IHIE (NCT01446705)
- Testing
- Active Health Information Exchange, Non-Active Health Information exchange
- Where
- United States
- Volunteers
- 57,073 people
- Sponsor
- VA Office of Research and Development